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1383 lines
116 KiB
HTML
1383 lines
116 KiB
HTML
<!DOCTYPE html>
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<html xmlns="http://www.w3.org/1999/xhtml" lang='en'>
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<head>
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<meta charset="UTF-8"><title>History of Changes for Study: NCT00658567</title>
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<script src="html/images/../jquery/js/jquery.min.js?v=3.5.1"></script><noscript></noscript>
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<link rel="stylesheet" type="text/css" href="html/css/HistoryDiffsStyle.css?v=b40">
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<meta name="ncbi_app" content="ctgov-archive"/>
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<meta name="ncbi_db" content="ctgov"/>
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<meta name="ncbi_pdid" content="HomePage"/>
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</head><body>
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<div id="ArchiveHeader" class="wrapper"><img class="responsive-image" src="html/images/ct.gov-nlm-nih-archive-logo.png" alt="ClinicalTrials.gov" style="margin:2px;">
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</div>
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<hr class="fancyDivider" style="clear:both;">
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<div id="controls" class="wrapper">
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<div style="text-align:center;font-size:larger;font-weight:bold;padding:14px 10px 0;">History of Changes for Study: NCT00658567</div>
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<div style="text-align:center;font-size:larger;font-weight:bold;padding:14px 10px;">A Study of Safety and Efficacy of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis</div>
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<div style="text-align:center;font-size:smaller;margin-bottom:10px;"><a href="https://clinicaltrials.gov/ct2/show/NCT00658567">Latest version (submitted April 18, 2017) on ClinicalTrials.gov</a></div>
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<div style="clear:both;"></div><div class="w3-container">
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<div class="w3-row">
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<div class="w3-col l4" style="float:right;">
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<div style="font-size:smaller;padding:10px; color:navy;">
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<ul class="instructions">
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<li>A study version is represented by a row in the table.</li>
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<li>Select two study versions to compare. One each from columns A and B.</li>
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<li>Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.</li>
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<li>Click "Compare" to do the comparison and show the differences.</li>
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<li>Select a version's Submitted Date link to see a rendering of the study for that version.</li>
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<li>The <span style="background-color: lightyellow;"> yellow A/B </span>choices in the table indicate the study versions currently compared below. A<span style="background-color: lightyellow;"> yellow </span>table row indicates the study version currently being viewed.</li>
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<li>Hover over the "<span class="recruitmentStatus">Recruitment Status</span>" to see how the study's recruitment status changed.</li>
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<li>Study edits or deletions are displayed in <span class="drop_hilite">red</span>.</li>
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<li>Study additions are displayed in <span class="add_hilite">green</span>.</li>
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</ul></div>
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</div>
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<div class="w3-col l8" style="float:left;">
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<form action="#StudyPageTop" data-ncbi-sg-search="true" onsubmit="sendSearchPing();" method="GET">
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<div class="w3-responsive"><fieldset class="releases ct-StdBackground"><legend class="releases">Study Record Versions</legend><table class="w3-bordered releases">
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<thead><tr>
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<th style="text-align:center;border-right:1px solid dimgrey;" id="VersionNumber">Version</th>
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<th style="text-align:center;border-right:1px solid dimgrey;" id="ColumnA">A</th>
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<th style="text-align:center;border-right:1px solid dimgrey;" id="ColumnB">B</th>
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<th style="text-align:center;border-right:1px solid dimgrey;white-space:nowrap;" id="VersionDate">Submitted Date</th>
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<th style="text-align:center; width:100%;" id="Changes">Changes</th>
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</tr></thead><tbody><tr>
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<td headers="VersionNumber">1</td><td headers="ColumnA" class="currentChoice"><input type="radio" name="A" title="Column A, study version 1" value="1" checked ></td>
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<td headers="ColumnB"><input type="radio" name="B" title="Column B, study version 1" value="1" ></td>
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<td style="text-align:right;white-space:nowrap;" headers="VersionDate"><a href="?V_1=View#StudyPageTop" title="View study version (1) dated April 10, 2008">April 10, 2008</a>
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</td>
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<td style="text-align:left;" headers="Changes">None (earliest Version on record)<tr>
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<td headers="VersionNumber">2</td><td headers="ColumnA"><input type="radio" name="A" title="Column A, study version 2" value="2" ></td>
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<td headers="ColumnB"><input type="radio" name="B" title="Column B, study version 2" value="2" ></td>
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<td style="text-align:right;white-space:nowrap;" headers="VersionDate"><a href="?V_2=View#StudyPageTop" title="View study version (2) dated May 19, 2008">May 19, 2008</a>
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</td>
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<td style="text-align:left;" headers="Changes">Study Status and Contacts/Locations</td>
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</tr>
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<tr>
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<td headers="VersionNumber">3</td><td headers="ColumnA"><input type="radio" name="A" title="Column A, study version 3" value="3" ></td>
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<td headers="ColumnB"><input type="radio" name="B" title="Column B, study version 3" value="3" ></td>
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<td style="text-align:right;white-space:nowrap;" headers="VersionDate"><a href="?V_3=View#StudyPageTop" title="View study version (3) dated August 25, 2008">August 25, 2008</a>
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</td>
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<td style="text-align:left;" headers="Changes">Study Status and Contacts/Locations</td>
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</tr>
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<tr>
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<td headers="VersionNumber">4</td><td headers="ColumnA"><input type="radio" name="A" title="Column A, study version 4" value="4" ></td>
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<td headers="ColumnB"><input type="radio" name="B" title="Column B, study version 4" value="4" ></td>
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<td style="text-align:right;white-space:nowrap;" headers="VersionDate"><a href="?V_4=View#StudyPageTop" title="View study version (4) dated September 24, 2008">September 24, 2008</a>
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</td>
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<td style="text-align:left;" headers="Changes">Study Status and Contacts/Locations</td>
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</tr>
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<tr>
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<td headers="VersionNumber">5</td><td headers="ColumnA"><input type="radio" name="A" title="Column A, study version 5" value="5" ></td>
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<td headers="ColumnB"><input type="radio" name="B" title="Column B, study version 5" value="5" ></td>
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<td style="text-align:right;white-space:nowrap;" headers="VersionDate"><a href="?V_5=View#StudyPageTop" title="View study version (5) dated October 20, 2008">October 20, 2008</a>
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</td>
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<td style="text-align:left;" headers="Changes">Study Status and Contacts/Locations</td>
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</tr>
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<tr>
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<td headers="VersionNumber">6</td><td headers="ColumnA"><input type="radio" name="A" title="Column A, study version 6" value="6" ></td>
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<td headers="ColumnB"><input type="radio" name="B" title="Column B, study version 6" value="6" ></td>
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<td style="text-align:right;white-space:nowrap;" headers="VersionDate"><a href="?V_6=View#StudyPageTop" title="View study version (6) dated November 17, 2008">November 17, 2008</a>
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</td>
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<td style="text-align:left;" headers="Changes">Study Status and Contacts/Locations</td>
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</tr>
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<tr>
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<td headers="VersionNumber">7</td><td headers="ColumnA"><input type="radio" name="A" title="Column A, study version 7" value="7" ></td>
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<td headers="ColumnB"><input type="radio" name="B" title="Column B, study version 7" value="7" ></td>
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<td style="text-align:right;white-space:nowrap;" headers="VersionDate"><a href="?V_7=View#StudyPageTop" title="View study version (7) dated December 17, 2008">December 17, 2008</a>
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</td>
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<td style="text-align:left;" headers="Changes">Contacts/Locations, Study Status and Eligibility</td>
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</tr>
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<tr>
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<td headers="VersionNumber">8</td><td headers="ColumnA"><input type="radio" name="A" title="Column A, study version 8" value="8" ></td>
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<td headers="ColumnB"><input type="radio" name="B" title="Column B, study version 8" value="8" ></td>
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<td style="text-align:right;white-space:nowrap;" headers="VersionDate"><a href="?V_8=View#StudyPageTop" title="View study version (8) dated February 16, 2009">February 16, 2009</a>
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</td>
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<td style="text-align:left;" headers="Changes">Study Status and Contacts/Locations</td>
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</tr>
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<tr>
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<td headers="VersionNumber">9</td><td headers="ColumnA"><input type="radio" name="A" title="Column A, study version 9" value="9" ></td>
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<td headers="ColumnB"><input type="radio" name="B" title="Column B, study version 9" value="9" ></td>
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<td style="text-align:right;white-space:nowrap;" headers="VersionDate"><a href="?V_9=View#StudyPageTop" title="View study version (9) dated March 26, 2009">March 26, 2009</a>
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</td>
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<td style="text-align:left;" headers="Changes">Study Status and Contacts/Locations</td>
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</tr>
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<tr>
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<td headers="VersionNumber">10</td><td headers="ColumnA"><input type="radio" name="A" title="Column A, study version 10" value="10" ></td>
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<td headers="ColumnB"><input type="radio" name="B" title="Column B, study version 10" value="10" ></td>
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<td style="text-align:right;white-space:nowrap;" headers="VersionDate"><a href="?V_10=View#StudyPageTop" title="View study version (10) dated April 16, 2009">April 16, 2009</a>
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</td>
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<td style="text-align:left;" headers="Changes">Study Status and Contacts/Locations</td>
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</tr>
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<tr>
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<td headers="VersionNumber">11</td><td headers="ColumnA"><input type="radio" name="A" title="Column A, study version 11" value="11" ></td>
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<td headers="ColumnB"><input type="radio" name="B" title="Column B, study version 11" value="11" ></td>
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<td style="text-align:right;white-space:nowrap;" headers="VersionDate"><a href="?V_11=View#StudyPageTop" title="View study version (11) dated June 16, 2009">June 16, 2009</a>
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</td>
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<td style="text-align:left;" headers="Changes">Contacts/Locations and Study Status</td>
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</tr>
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<tr>
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<td headers="VersionNumber">12</td><td headers="ColumnA"><input type="radio" name="A" title="Column A, study version 12" value="12" ></td>
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<td headers="ColumnB"><input type="radio" name="B" title="Column B, study version 12" value="12" ></td>
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<td style="text-align:right;white-space:nowrap;" headers="VersionDate"><a href="?V_12=View#StudyPageTop" title="View study version (12) dated July 16, 2009">July 16, 2009</a>
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</td>
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<td style="text-align:left;" headers="Changes">Study Status and Contacts/Locations</td>
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</tr>
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<tr>
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<td headers="VersionNumber">13</td><td headers="ColumnA"><input type="radio" name="A" title="Column A, study version 13" value="13" ></td>
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<td headers="ColumnB"><input type="radio" name="B" title="Column B, study version 13" value="13" ></td>
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<td style="text-align:right;white-space:nowrap;" headers="VersionDate"><a href="?V_13=View#StudyPageTop" title="View study version (13) dated August 4, 2010">August 4, 2010</a>
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</td>
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<td style="text-align:left;" headers="Changes"><span class="recruitmentStatus" title="Recruiting --> Completed">Recruitment Status</span>, Study Status, Contacts/Locations and Sponsor/Collaborators</td>
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</tr>
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<tr>
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<td headers="VersionNumber">14</td><td headers="ColumnA"><input type="radio" name="A" title="Column A, study version 14" value="14" ></td>
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<td headers="ColumnB"><input type="radio" name="B" title="Column B, study version 14" value="14" ></td>
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<td style="text-align:right;white-space:nowrap;" headers="VersionDate"><a href="?V_14=View#StudyPageTop" title="View study version (14) dated August 29, 2014">August 29, 2014</a>
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</td>
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<td style="text-align:left;" headers="Changes">Study Status, Outcome Measures, Sponsor/Collaborators, Arms and Interventions, Study Design, Results and Eligibility</td>
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</tr>
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<tr>
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<td headers="VersionNumber">15</td><td headers="ColumnA"><input type="radio" name="A" title="Column A, study version 15" value="15" ></td>
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<td headers="ColumnB" class="currentChoice"><input type="radio" name="B" title="Column B, study version 15" value="15" checked ></td>
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<td style="text-align:right;white-space:nowrap;" headers="VersionDate"><a href="?V_15=View#StudyPageTop" title="View study version (15) dated April 18, 2017">April 18, 2017</a>
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</td>
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<td style="text-align:left;" headers="Changes">Oversight, Study Status, IPDSharing and Contacts/Locations</td>
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</tr>
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</tbody></table>
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<div class="w3-left-align" style="margin-top:10px;">
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<input type="submit" class="compareButton" value="Compare" title="Compare" autofocus/>
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<div class="controls">
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<span style="white-space:nowrap;">Comparison Format:</span>
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<ul class="format w3-left-align">
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<li><label for="mergedCB" title="Use merged format everywhere" >
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<input type="radio" id="mergedCB" name="C" value="merged" checked> Merged
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</label></li>
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<li><label for="sbsCB" title="Side-by-Side (applies only to Protocol Section)">
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<input type="radio" id="sbsCB" name="C" value="Side-by-Side"> Side-by-Side
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</label></li>
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</ul>
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</div>
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</div>
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</fieldset>
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</div>
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</form>
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</div></div></div>
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</div>
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<a id="StudyPageTop"></a><hr class="fancyDivider" style="margin:2px auto;">
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<div style="padding:3px;text-align:center;font-size:smaller;color:grey;"><a href="javascript:;" onClick="document.getElementById('controls').scrollIntoView();">Scroll up to access the controls</a></div>
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<hr class="fancyDivider" style="margin:2px auto 6px auto;">
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<div class="wrapper" style="text-align:center;font-weight:bold;">
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Changes (Merged) for Study: NCT00658567<br>
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April 10, 2008 (v1) -- April 18, 2017 (v15)<br><br>Changes in: <a href="#StudyStatus" target="_self" title="Jump to the Study Status module" style="white-space:nowrap;">Study Status</a>, <a href="#SponsorCollaborators" target="_self" title="Jump to the Sponsor/Collaborators module" style="white-space:nowrap;">Sponsor/Collaborators</a>, <a href="#Oversight" target="_self" title="Jump to the Oversight module" style="white-space:nowrap;">Oversight</a>, <a href="#StudyDesign" target="_self" title="Jump to the Study Design module" style="white-space:nowrap;">Study Design</a>, <a href="#ArmsandInterventions" target="_self" title="Jump to the Arms and Interventions module" style="white-space:nowrap;">Arms and Interventions</a>, <a href="#ROutcomeMeasures" target="_self" title="Jump to the Outcome Measures module" style="white-space:nowrap;">Outcome Measures</a>, <a href="#Eligibility" target="_self" title="Jump to the Eligibility module" style="white-space:nowrap;">Eligibility</a>, <a href="#ContactsLocations" target="_self" title="Jump to the Contacts/Locations module" style="white-space:nowrap;">Contacts/Locations</a>, <a href="#IPDSharing" target="_self" title="Jump to the IPDSharing module" style="white-space:nowrap;">IPDSharing</a> and <a href="#Results" target="_self" title="Jump to the Results module" style="white-space:nowrap;">Results</a><script type="text/javascript">
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$(window).on("load", function() {
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var hash = window.location.hash;
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if (hash !== null && hash != "") {
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$(hash).get(0).scrollIntoView(true);}
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});function toggleModule(theModuleId) {
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var theModuleBody = $('#'+theModuleId+'Body');
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$('#'+theModuleId+'Img').attr("src", (theModuleBody.css("display") == "none") ?
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"html/images/collapse.png" : "html/images/expand.png") ;
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theModuleBody.fadeToggle('slow');
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};
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</script><noscript></noscript>
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<div style="margin-top:1ex;padding:4px;"><label for="OpenOnlyChangedModules">
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<input type="checkbox" id="OpenOnlyChangedModules" style="vertical-align:text-bottom;" onchange="setOpenOnlyChangedModules()"> Show only changed modules</label></div>
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<script type="text/javascript">
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var ChangedModules = [];
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var theModule = "StudyStatus";ChangedModules.push(theModule);
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if (theModule === "ROutcomeMeasures") ChangedModules.push("ProtocolOutcomeMeasures");
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var theModule = "SponsorCollaborators";ChangedModules.push(theModule);
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if (theModule === "ROutcomeMeasures") ChangedModules.push("ProtocolOutcomeMeasures");
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var theModule = "Oversight";ChangedModules.push(theModule);
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if (theModule === "ROutcomeMeasures") ChangedModules.push("ProtocolOutcomeMeasures");
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var theModule = "StudyDesign";ChangedModules.push(theModule);
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if (theModule === "ROutcomeMeasures") ChangedModules.push("ProtocolOutcomeMeasures");
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var theModule = "ArmsandInterventions";ChangedModules.push(theModule);
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if (theModule === "ROutcomeMeasures") ChangedModules.push("ProtocolOutcomeMeasures");
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var theModule = "ROutcomeMeasures";ChangedModules.push(theModule);
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if (theModule === "ROutcomeMeasures") ChangedModules.push("ProtocolOutcomeMeasures");
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var theModule = "Eligibility";ChangedModules.push(theModule);
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if (theModule === "ROutcomeMeasures") ChangedModules.push("ProtocolOutcomeMeasures");
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var theModule = "ContactsLocations";ChangedModules.push(theModule);
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if (theModule === "ROutcomeMeasures") ChangedModules.push("ProtocolOutcomeMeasures");
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var theModule = "IPDSharing";ChangedModules.push(theModule);
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if (theModule === "ROutcomeMeasures") ChangedModules.push("ProtocolOutcomeMeasures");
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var theModule = "Results";ChangedModules.push(theModule);
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if (theModule === "ROutcomeMeasures") ChangedModules.push("ProtocolOutcomeMeasures");
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ChangedModules.push("AdverseEvents");
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ChangedModules.push("LimitationsandCaveats");
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ChangedModules.push("MoreInformation");
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var OpenOnlyChangedModules = false;
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function getIndexOf(theArray, theValue) {
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if (theArray === null || theValue === null) return -1;
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for (var i = 0; i < theArray.length; ++i) {
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if (theArray[i] == theValue) return i;
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}
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return -1;
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function setOpenOnlyChangedModules() {
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var cbChecked = $('#OpenOnlyChangedModules').is(':checked'); if (cbChecked === OpenOnlyChangedModules) return;
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OpenOnlyChangedModules = cbChecked;
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localStorage.setItem('CT_Archive_OpenOnlyChangedModules', JSON.stringify( OpenOnlyChangedModules ));
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resetAllModules();
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function closeModuleIfNotChanged(theModuleId) {
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$(document).ready(function() {
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$('#OpenOnlyChangedModules').prop('checked', true);
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</script><noscript></noscript>
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</div>
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<hr>
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<table class="history">
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<thead><tr><th></th><th></th></tr></thead><tbody>
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<tr><td colspan="2"><a id="Protocol"></a></td></tr>
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<tr>
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<td colspan="2">
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<form id="form_StudyIdentification"><div class="w3-responsive"><fieldset class="entryReq" id="StudyIdentification" style="margin:auto;margin-bottom:1em;padding-bottom:0.5em;width:98%;">
|
|
<legend class="moduleLabel"> <img id="StudyIdentificationImg" class="toggleImage" onclick="toggleModule('StudyIdentification');" src="html/images/collapse.png" alt='Open or close this module'>
|
|
Study Identification</legend>
|
|
<div id="StudyIdentificationBody" class="moduleBody">
|
|
<table class="indent1 moduleTable resultTable"><thead><tr>
|
|
<th style="width:210px;"></th>
|
|
<th></th>
|
|
</tr></thead><tbody>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Unique Protocol ID:</td>
|
|
<td>ACP-103-014 </td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Brief Title:</td>
|
|
<td>A Study of Safety and Efficacy of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis </td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Official Title:</td>
|
|
<td></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Secondary IDs:</td>
|
|
<td></td></tr>
|
|
</tbody>
|
|
</table>
|
|
</div>
|
|
</fieldset>
|
|
</div>
|
|
</form>
|
|
</td></tr>
|
|
<tr>
|
|
<td colspan="2">
|
|
<form id="form_StudyStatus"><div class="w3-responsive"><fieldset class="entryReq" id="StudyStatus" style="margin:auto;margin-bottom:1em;padding-bottom:0.5em;width:98%;">
|
|
<legend class="moduleLabel"> <img id="StudyStatusImg" class="toggleImage" onclick="toggleModule('StudyStatus');" src="html/images/collapse.png" alt='Open or close this module'>
|
|
Study Status</legend>
|
|
<div id="StudyStatusBody" class="moduleBody">
|
|
<table class="indent1 moduleTable resultTable"><thead><tr>
|
|
<th style="width:210px;"></th>
|
|
<th></th>
|
|
</tr></thead><tbody>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Record Verification:</td>
|
|
<td>April <span class="drop_hilite">2008</span> <span class="add_hilite">2017</span> </td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Overall Status:</td>
|
|
<td><span class="drop_hilite">Recruiting</span> <span class="add_hilite">Completed</span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Study Start:</td>
|
|
<td>March 2008 </td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Primary Completion:</td>
|
|
<td> <span class="add_hilite">December 2009 [Actual]</span> </td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Study Completion:</td>
|
|
<td>December 2009 [ <span class="drop_hilite">Anticipated</span> <span class="add_hilite">Actual</span>] </td>
|
|
</tr>
|
|
<tr style="border-bottom:1px solid lightgray"><td colspan="3"></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">First Submitted:</td>
|
|
<td>April 10, 2008 </td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">First Submitted that<br/>Met QC Criteria:</td>
|
|
<td>April 10, 2008 </td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">First Posted:</td>
|
|
<td>April 15, 2008 [Estimate] </td>
|
|
</tr>
|
|
<tr style="border-bottom:1px solid lightgray"><td colspan="3"></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Results First Submitted:</td>
|
|
<td> <span class="add_hilite">February 6, 2014</span> </td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Results First Submitted that<br/>Met QC Criteria:</td>
|
|
<td> <span class="add_hilite">August 29, 2014</span> </td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Results First Posted:</td>
|
|
<td> <span class="add_hilite">September 9, 2014 [Estimate]</span> </td>
|
|
</tr>
|
|
<tr style="border-bottom:1px solid lightgray"><td colspan="3"></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Last Update Submitted that<br/>Met QC Criteria:</td>
|
|
<td>April <span class="drop_hilite">10</span> <span class="add_hilite">18</span>, <span class="drop_hilite">2008</span> <span class="add_hilite">2017</span> </td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Last Update Posted:</td>
|
|
<td><span class="drop_hilite">April 15, 2008 [Estimate]</span> <span class="add_hilite">May 19, 2017 [Actual]</span> </td>
|
|
</tr>
|
|
</tbody>
|
|
</table>
|
|
</div>
|
|
</fieldset>
|
|
</div>
|
|
</form>
|
|
</td></tr>
|
|
<tr>
|
|
<td colspan="2">
|
|
<form id="form_SponsorCollaborators"><div class="w3-responsive"><fieldset class="entryReq" id="SponsorCollaborators" style="margin:auto;margin-bottom:1em;padding-bottom:0.5em;width:98%;">
|
|
<legend class="moduleLabel"> <img id="SponsorCollaboratorsImg" class="toggleImage" onclick="toggleModule('SponsorCollaborators');" src="html/images/collapse.png" alt='Open or close this module'>
|
|
Sponsor/Collaborators</legend>
|
|
<div id="SponsorCollaboratorsBody" class="moduleBody">
|
|
<table class="indent1 moduleTable resultTable"><thead><tr>
|
|
<th style="width:210px;"></th>
|
|
<th></th>
|
|
</tr></thead><tbody>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Sponsor:</td>
|
|
<td>ACADIA Pharmaceuticals Inc. </td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Responsible Party:</td>
|
|
<td> <span class="add_hilite">Sponsor</span> </td>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Collaborators:</td>
|
|
<td></td></tr>
|
|
</tbody>
|
|
</table>
|
|
</div>
|
|
</fieldset>
|
|
</div>
|
|
</form>
|
|
</td></tr>
|
|
<tr>
|
|
<td colspan="2">
|
|
<form id="form_Oversight"><div class="w3-responsive"><fieldset class="entryReq" id="Oversight" style="margin:auto;margin-bottom:1em;padding-bottom:0.5em;width:98%;">
|
|
<legend class="moduleLabel"> <img id="OversightImg" class="toggleImage" onclick="toggleModule('Oversight');" src="html/images/collapse.png" alt='Open or close this module'>
|
|
Oversight</legend>
|
|
<div id="OversightBody" class="moduleBody">
|
|
<table class="indent1 moduleTable resultTable"><thead><tr>
|
|
<th style="width:210px;"></th>
|
|
<th></th>
|
|
</tr></thead><tbody>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">U.S. FDA-regulated Drug:</td>
|
|
<td> <span class="add_hilite">Yes</span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">U.S. FDA-regulated Device:</td>
|
|
<td> <span class="add_hilite">No</span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Data Monitoring:</td>
|
|
<td> <span class="add_hilite">No</span> </td>
|
|
</tr>
|
|
</tbody>
|
|
</table>
|
|
</div>
|
|
</fieldset>
|
|
</div>
|
|
</form>
|
|
</td></tr>
|
|
<tr>
|
|
<td colspan="2">
|
|
<form id="form_StudyDescription"><div class="w3-responsive"><fieldset class="entryReq" id="StudyDescription" style="margin:auto;margin-bottom:1em;padding-bottom:0.5em;width:98%;">
|
|
<legend class="moduleLabel"> <img id="StudyDescriptionImg" class="toggleImage" onclick="toggleModule('StudyDescription');" src="html/images/collapse.png" alt='Open or close this module'>
|
|
Study Description</legend>
|
|
<div id="StudyDescriptionBody" class="moduleBody">
|
|
<table class="indent1 moduleTable resultTable"><thead><tr>
|
|
<th style="width:210px;"></th>
|
|
<th></th>
|
|
</tr></thead><tbody>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Brief Summary:</td>
|
|
<td>This study will evaluate the safety and efficacy of two dose levels of pimavanserin (ACP-103) compared to placebo in patients with Parkinson's disease psychosis. </td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Detailed Description:</td>
|
|
<td></td></tr>
|
|
</tbody>
|
|
</table>
|
|
</div>
|
|
</fieldset>
|
|
</div>
|
|
</form>
|
|
</td></tr>
|
|
<tr>
|
|
<td colspan="2">
|
|
<form id="form_Conditions"><div class="w3-responsive"><fieldset class="entryReq" id="Conditions" style="margin:auto;margin-bottom:1em;padding-bottom:0.5em;width:98%;">
|
|
<legend class="moduleLabel"> <img id="ConditionsImg" class="toggleImage" onclick="toggleModule('Conditions');" src="html/images/collapse.png" alt='Open or close this module'>
|
|
Conditions</legend>
|
|
<div id="ConditionsBody" class="moduleBody">
|
|
<table class="indent1 moduleTable resultTable"><thead><tr>
|
|
<th style="width:210px;"></th>
|
|
<th></th>
|
|
</tr></thead><tbody>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Conditions:</td>
|
|
<td>Parkinson's Disease Psychosis </td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Keywords:</td>
|
|
<td></td></tr>
|
|
</tbody>
|
|
</table>
|
|
</div>
|
|
</fieldset>
|
|
</div>
|
|
</form>
|
|
</td></tr>
|
|
<tr>
|
|
<td colspan="2">
|
|
<form id="form_StudyDesign"><div class="w3-responsive"><fieldset class="entryReq" id="StudyDesign" style="margin:auto;margin-bottom:1em;padding-bottom:0.5em;width:98%;">
|
|
<legend class="moduleLabel"> <img id="StudyDesignImg" class="toggleImage" onclick="toggleModule('StudyDesign');" src="html/images/collapse.png" alt='Open or close this module'>
|
|
Study Design</legend>
|
|
<div id="StudyDesignBody" class="moduleBody">
|
|
<table class="indent1 moduleTable resultTable"><thead><tr>
|
|
<th style="width:210px;"></th>
|
|
<th></th>
|
|
</tr></thead><tbody>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Study Type:</td>
|
|
<td>Interventional</td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Primary Purpose:</td>
|
|
<td>Treatment</td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Study Phase:</td>
|
|
<td>Phase 3</td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Interventional Study Model:</td>
|
|
<td>Parallel Assignment </td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Number of Arms:</td>
|
|
<td>3</td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Masking:</td>
|
|
<td>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Allocation:</td>
|
|
<td>Randomized</td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Enrollment:</td>
|
|
<td><span class="drop_hilite">240 [Anticipated]</span> <span class="add_hilite">123 [Actual]</span> </td>
|
|
</tr>
|
|
</tbody>
|
|
</table>
|
|
</div>
|
|
</fieldset>
|
|
</div>
|
|
</form>
|
|
</td></tr>
|
|
<tr>
|
|
<td colspan="2">
|
|
<form id="form_ArmsandInterventions"><div class="w3-responsive"><fieldset class="entryReq" id="ArmsandInterventions" style="margin:auto;margin-bottom:1em;padding-bottom:0.5em;width:98%;">
|
|
<legend class="moduleLabel"> <img id="ArmsandInterventionsImg" class="toggleImage" onclick="toggleModule('ArmsandInterventions');" src="html/images/collapse.png" alt='Open or close this module'>
|
|
Arms and Interventions</legend>
|
|
<div id="ArmsandInterventionsBody" class="moduleBody">
|
|
<table class="indent1 moduleTable resultTable"><thead><tr>
|
|
<th style="width:210px;"></th>
|
|
<th></th>
|
|
</tr></thead><tbody>
|
|
<tr><td colspan="2"><table class="ArmsInterv">
|
|
<thead>
|
|
<tr><th style="width:60%;">Arms</th>
|
|
<th>Assigned Interventions</th>
|
|
</tr></thead>
|
|
<tbody>
|
|
<tr style="border:1px solid gray"><td>Experimental: 2<div class="indent1">pimavanserin tartrate (ACP-103) 20 mg, tablet, once daily by mouth, 6 weeks</div></td>
|
|
<td>Drug: Pimavanserin tartrate (ACP-103)<div class="indent1">20 mg, tablet, once daily by mouth, for six weeks</div> </td>
|
|
</tr>
|
|
<tr style="border:1px solid gray"><td>Placebo Comparator: <span class="drop_hilite">3</span> <span class="add_hilite">Placebo</span><div class="indent1">Placebo tablet, once daily by mouth, 6 weeks</div></td>
|
|
<td>Drug: Pimavanserin tartrate (ACP-103)<div class="indent1">Placebo, tablet, once daily by mouth, for six weeks</div> </td>
|
|
</tr>
|
|
<tr style="border:1px solid gray"><td>Experimental: 1<div class="indent1">pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks</div></td>
|
|
<td>Drug: Pimavanserin tartrate (ACP-103)<div class="indent1">10 mg, tablet, once daily by mouth, for six weeks</div> </td>
|
|
</tr>
|
|
</tbody></table>
|
|
</td></tr>
|
|
</tbody>
|
|
</table>
|
|
</div>
|
|
</fieldset>
|
|
</div>
|
|
</form>
|
|
</td></tr>
|
|
<tr>
|
|
<td colspan="2">
|
|
<form id="form_ProtocolOutcomeMeasures"><div class="w3-responsive"><fieldset class="entryReq" id="ProtocolOutcomeMeasures" style="margin:auto;margin-bottom:1em;padding-bottom:0.5em;width:98%;">
|
|
<legend class="moduleLabel"> <img id="ProtocolOutcomeMeasuresImg" class="toggleImage" onclick="toggleModule('ProtocolOutcomeMeasures');" src="html/images/collapse.png" alt='Open or close this module'>
|
|
Outcome Measures</legend>
|
|
<div id="ProtocolOutcomeMeasuresBody" class="moduleBody">
|
|
<table class="indent1 moduleTable resultTable"><thead><tr>
|
|
<th style="width:3em;"></th>
|
|
<th></th>
|
|
</tr></thead><tbody>
|
|
<tr><a href="#ROutcomeMeasures" class="indent1" style="white-space:nowrap;" title="See Results Section Outcome Measures"> <span class="add_hilite">[See Results Section.]</span></a><tr><td class="rowLabel" style="white-space:nowrap;width: 3em;">Primary Outcome Measures:</td><td></td></tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="rowLabel" style="width:3em;white-space:nowrap;">1.</td>
|
|
<td><span class="drop_hilite">Antipsychotic efficacy will be assessed using the scale for the assessment of Positive Symptoms (SAPS)</span> <span class="add_hilite">Antipsychotic Efficacy</span><br>[ Time Frame: <span class="drop_hilite">6 weeks</span> <span class="add_hilite">Each study visit (i.e. Days 1, 8, 15, 29 and 42)</span> ]<br><br><p><span class="add_hilite">Antipsychotic efficacy was defined as a decrease in the severity and/or frequency of hallucinations and/or delusions. This is measured as the change from baseline (Day 1) to Day 42 in the Scale for the Assessment of Positive Symptoms - Hallucinations and Delusions scales (SAPS-H+D) score for the ITT Analysis Set. The possible total score is 1 to 100 and a negative change in score indicates improvement.
|
|
</span></p>
|
|
|
|
<p><span class="add_hilite">Analysis Method: Analysis of Covariance (ANCOVA) and missing data was imputed using Last Observation Carried Forward (LOCF) method.
|
|
</span></p>
|
|
|
|
</td>
|
|
</tr><tr><td class="rowLabel" style="white-space:nowrap;width: 3em;">Secondary Outcome Measures:</td><td></td></tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="rowLabel" style="width:3em;white-space:nowrap;"> <span class="add_hilite">1</span>.</td>
|
|
<td> <span class="add_hilite">Motor Symptoms Change From Baseline (Negative = Improvement)</span><br>[ Time Frame: <span class="add_hilite">Each study visit (i.e. Days 1, 8, 15, 29 and 42)</span> ]<br><br><p><span class="add_hilite">Motor symptoms were measured using the change from baseline (Day 1) to Day 42 in the combined score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) and Part III (Motor Examination). The total possible score is 0 to 160 and a negative change in score indicates improvement.
|
|
</span></p>
|
|
|
|
<p><span class="add_hilite">Analysis Method: ANCOVA, and missing data was imputed using LOCF method. The UPDRS Parts II+III score was analyzed by constructing 2-sided 95% confidence intervals (CIs) on the difference between each pimavanserin dose group and placebo mean change from baseline. Non-inferiority was concluded if the upper limit of the CI was less than or equal to 5.
|
|
</span></p>
|
|
|
|
</td>
|
|
</tr> </tbody>
|
|
</table>
|
|
</div>
|
|
</fieldset>
|
|
</div>
|
|
</form>
|
|
</td></tr>
|
|
<tr>
|
|
<td colspan="2">
|
|
<form id="form_Eligibility"><div class="w3-responsive"><fieldset class="entryReq" id="Eligibility" style="margin:auto;margin-bottom:1em;padding-bottom:0.5em;width:98%;">
|
|
<legend class="moduleLabel"> <img id="EligibilityImg" class="toggleImage" onclick="toggleModule('Eligibility');" src="html/images/collapse.png" alt='Open or close this module'>
|
|
Eligibility</legend>
|
|
<div id="EligibilityBody" class="moduleBody">
|
|
<table class="indent1 moduleTable resultTable"><thead><tr>
|
|
<th style="width:210px;"></th>
|
|
<th></th>
|
|
</tr></thead><tbody>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Minimum Age:</td>
|
|
<td>40 Years </td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Maximum Age:</td>
|
|
<td></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Sex:</td>
|
|
<td>All </td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Gender Based:</td>
|
|
<td></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Accepts Healthy Volunteers:</td>
|
|
<td>No</td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Criteria:</td>
|
|
<td><p>Inclusion Criteria:</p><ul>
|
|
<li>A clinical diagnosis of Parkinson's disease with a minimum duration of 1 year</li><li>Presence of visual and/or auditory hallucinations, and/or delusions, occurring during the four weeks prior to study screening</li><li>Psychotic symptoms must have developed after Parkinson's disease diagnosis was established</li><li>Subject must be on stable dose of anti-Parkinson's medication for 1 month prior to Study Day 1 (Baseline) and during the trial</li><li>Subject that has received stereotaxic surgery for subthalamic nucleus deep brain stimulation must be at least 6 months post surgery and the stimulator settings must have been stable for at least 1 month prior to Study Day 1 (Baseline) and must remain stable during the trial</li><li>The subject is willing and able to provide consent</li><li>Caregiver is willing and able to accompany the subject to all visits</li></ul>
|
|
<p>Exclusion Criteria:</p><ul>
|
|
<li>Subject has a history of significant psychotic disorders prior to or concomitantly with the diagnosis of Parkinson's disease including, but not limited to, schizophrenia or bipolar disorder</li><li>Subject has received previous ablative stereotaxic surgery ( <span class="drop_hilite">is</span> <span class="add_hilite">i</span>.<span class="add_hilite">e.</span>, pallidotomy and thalamotomy) to treat Parkinson's disease</li><li>Subject has current evidence of a serious and or unstable cardiovascular, respiratory, gastrointestinal, renal, <span class="drop_hilite">mematologic </span> <span class="add_hilite">hematologic </span>or other medical disorder</li><li>Subject has had a myocardial infarction in last six months</li><li>Subject has any surgery planned during the screening, treatment or follow-up periods</li></ul>
|
|
<p>Patients will be evaluated at screening to ensure that all criteria for study participation are met. These evaluations will include specific measures of psychosis severity, delirium, dementia, cardiovascular condition, and pregnancy status. Patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline health and psychiatric condition do not meet all protocol-specified entry criteria).</p> </td>
|
|
</tr>
|
|
</tbody>
|
|
</table>
|
|
</div>
|
|
</fieldset>
|
|
</div>
|
|
</form>
|
|
</td></tr>
|
|
<tr>
|
|
<td colspan="2">
|
|
<form id="form_ContactsLocations"><div class="w3-responsive"><fieldset class="entryReq" id="ContactsLocations" style="margin:auto;margin-bottom:1em;padding-bottom:0.5em;width:98%;">
|
|
<legend class="moduleLabel"> <img id="ContactsLocationsImg" class="toggleImage" onclick="toggleModule('ContactsLocations');" src="html/images/collapse.png" alt='Open or close this module'>
|
|
Contacts/Locations</legend>
|
|
<div id="ContactsLocationsBody" class="moduleBody">
|
|
<table class="indent1 moduleTable resultTable"><thead><tr>
|
|
<th style="width:210px;"></th>
|
|
<th></th>
|
|
</tr></thead><tbody>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Central Contact Person:</td>
|
|
<td><span class="drop_hilite">Kimberly Wilson<br><span class="indent1">Email: ACP-103clintrials@acadia-pharm.com</span></span> </td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Locations:</td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">United States, California</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">La Habra, California, United States, 90631</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Laguna Hills, California, United States, 92653</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td><span class="drop_hilite"><span style="font-weight:bold;">United States, California</span></span> </td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="drop_hilite">[Recruiting]<br></span> <span class="indent1">Reseda, California, United States</span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Ventura, California, United States, 93003</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">United States, Colorado</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Englewood, Colorado, United States, 80113</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">United States, Connecticut</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Farmington, Connecticut, United States, 06030</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">United States, Florida</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Deerfield Beach, Florida, United States, 33064</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Panama City, Florida, United States, 32405</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Sarasota, Florida, United States, 34233</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">United States, Massachusetts</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Boston, Massachusetts, United States, 02215</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Worcester, Massachusetts, United States, 01655</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">United States, Michigan</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Clinton, Michigan, United States, 48035</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Detroit, Michigan, United States, 48201</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">East Lansing, Michigan, United States, 48824</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">United States, Missouri</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Columbia, Missouri, United States, 65201</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">United States, Nebraska</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Omaha, Nebraska, United States, 68131</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">United States, New York</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Albany, New York, United States, 12208</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Commack, New York, United States, 11725</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">United States, North Carolina</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Charlotte, North Carolina, United States, 28204</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Durham, North Carolina, United States, 27705</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td><span class="drop_hilite"><span style="font-weight:bold;">United States, North Carolina</span></span> </td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="drop_hilite">[Recruiting]<br></span> <span class="indent1">New Bern, North Carolina, United States</span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">United States, Ohio</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Toledo, Ohio, United States, 43614</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">United States, Pennsylvania</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Philadelphia, Pennsylvania, United States, 19131</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Philadelphia, Pennsylvania, United States, 19141</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">United States, Texas</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Houston, Texas, United States, 77030</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">United States, Vermont</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Burlington, Vermont, United States, 05401</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">Austria</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Innsbruck, Austria, 6020</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">Belgium</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Brussels, Belgium, 1090</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Ottignies, Belgium, 1340</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Roeselare, Belgium, 8800</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">Italy</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Chieti Scalo, Italy, 66013</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Grossetto, Italy, 58100</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Roma, Italy, 00163</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Roma, Italy, 00185</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">Poland</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Bydgoszcz, Poland, 85-096</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Katowice, Poland, 40-752</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Lodz, Poland, 90-130</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Lublin, Poland, 20-090</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">Portugal</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Coimbra, Portugal, 3000-548</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Lisboa, Portugal, 1649-028</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Porto, Portugal, 4099-001</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">Serbia</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Belgrade, Serbia, 11000</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">Spain</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Barcelona, Spain, 08003</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Barcelona, Spain, 08036</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Barcelona, Spain, 08195</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">San Sebastian, Spain, 20009</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Santiago De Compostela, Spain, 15706</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">Sweden</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Jonkoping, Sweden, SE-551 85</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Linkoping, Sweden, SE-581 85</span></span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Stockholm, Sweden, SE-112 45</span></span></td></tr>
|
|
</tbody>
|
|
</table>
|
|
</div>
|
|
</fieldset>
|
|
</div>
|
|
</form>
|
|
</td></tr>
|
|
<tr>
|
|
<td colspan="2">
|
|
<form id="form_IPDSharing"><div class="w3-responsive"><fieldset class="entryReq" id="IPDSharing" style="margin:auto;margin-bottom:1em;padding-bottom:0.5em;width:98%;">
|
|
<legend class="moduleLabel"> <img id="IPDSharingImg" class="toggleImage" onclick="toggleModule('IPDSharing');" src="html/images/collapse.png" alt='Open or close this module'>
|
|
IPDSharing</legend>
|
|
<div id="IPDSharingBody" class="moduleBody">
|
|
<table class="indent1 moduleTable resultTable"><thead><tr>
|
|
<th style="width:210px;"></th>
|
|
<th></th>
|
|
</tr></thead><tbody>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Plan to Share IPD:</td>
|
|
<td> <span class="add_hilite">No</span> </td>
|
|
</tr>
|
|
</tbody>
|
|
</table>
|
|
</div>
|
|
</fieldset>
|
|
</div>
|
|
</form>
|
|
</td></tr>
|
|
<tr>
|
|
<td colspan="2">
|
|
<form id="form_References"><div class="w3-responsive"><fieldset class="entryReq" id="References" style="margin:auto;margin-bottom:1em;padding-bottom:0.5em;width:98%;">
|
|
<legend class="moduleLabel"> <img id="ReferencesImg" class="toggleImage" onclick="toggleModule('References');" src="html/images/collapse.png" alt='Open or close this module'>
|
|
References</legend>
|
|
<div id="ReferencesBody" class="moduleBody">
|
|
<table class="indent1 moduleTable resultTable"><thead><tr>
|
|
<th style="width:210px;"></th>
|
|
<th></th>
|
|
</tr></thead><tbody>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Citations:</td>
|
|
<td></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Links:</td>
|
|
<td></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Available IPD/Information:</td>
|
|
<td></td></tr>
|
|
</tbody>
|
|
</table>
|
|
</div>
|
|
</fieldset>
|
|
</div>
|
|
</form>
|
|
</td></tr>
|
|
<tr><td colspan="3"><a id="Results"></a><div class="sectionDivider">Study Results</div></td></tr>
|
|
<tr>
|
|
<td colspan=3>
|
|
<form id="form_ParticipantFlow"><a id="ParticipantFlow"></a><div><fieldset class="entryReq" style="margin:auto;margin-bottom:1em;width:98%;padding-bottom:0.5em;background-color:#F7F7F7;">
|
|
<legend class="moduleLabel"> <img id="ParticipantFlowImg" class="toggleImage" onclick="toggleModule('ParticipantFlow');" src="html/images/collapse.png" alt='Open or close this module'>
|
|
Participant Flow</legend>
|
|
<div id="ParticipantFlowBody" class="moduleBody">
|
|
<table class="moduleTable resultTable" style="margin-top:0.5em;">
|
|
<thead>
|
|
<tr style="display:none;"><th style="width:250px;"></th><th></th></tr>
|
|
</thead>
|
|
<tbody>
|
|
<tr style="vertical-align:top;">
|
|
<td class="resultLabelCellRight popFlowLabelCell" style="min-width: 250px;">Recruitment Details</td>
|
|
<td class="resultValueCell" style="text-align:left;width:100%"></td></tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="resultLabelCellRight popFlowLabelCell" style="min-width: 250px;">Pre-assignment Details</td>
|
|
<td class="resultValueCell" style="text-align:left;width:100%"></td></tr>
|
|
<tr><td colspan="2" style="margin-top:1em;"> </td></tr><tr><td colspan="2" style="padding:0;"><table class="resultTable" style="margin-top:1em;width:100%;empty-cells:show;">
|
|
<tbody><tr>
|
|
<th class="resultLabelCellRight popFlowLabelCell" style="min-width:250px;">Arm/Group Title</th>
|
|
<th class="resultLabelCell popFlowLabelCell" style="text-align:center;width:33%;"> <span class="add_hilite">Placebo</span></td>
|
|
<th class="resultLabelCell popFlowLabelCell" style="text-align:center;width:33%;"> <span class="add_hilite">Pimavanserin 10 mg</span></td>
|
|
<th class="resultLabelCell popFlowLabelCell" style="text-align:center;width:33%;"> <span class="add_hilite">Pimavanserin 20 mg</span></td>
|
|
</tr>
|
|
<tr><th class="resultLabelCellRight popFlowLabelCell">Arm/Group Description</th>
|
|
<th class="resultLabelCell popFlowLabelCell" style="text-align:left; width:33%;"><span class="add_hilite">Placebo tablet, once daily by mouth, 6 weeks
|
|
</span>
|
|
</th>
|
|
<th class="resultLabelCell popFlowLabelCell" style="text-align:left; width:33%;"><span class="add_hilite">Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
|
|
</span>
|
|
</th>
|
|
<th class="resultLabelCell popFlowLabelCell" style="text-align:left; width:33%;"><span class="add_hilite">Pimavanserin tartrate (ACP-103) 20 mg, tablet, once daily by mouth, 6 weeks
|
|
</span>
|
|
</th>
|
|
</tr>
|
|
<tr><td colspan="4"><tr><td style="padding-top: 1em;" colspan="4">Period Title: <span style="font-weight:bold;"> <span class="add_hilite">Overall Study</span></span></td></tr>
|
|
<tr><td class="resultLabelCellRight popFlowLabelCell popFlowLabelCompleted"> <span class="add_hilite">Started</span></td>
|
|
<td class="resultValueCell"> <span class="add_hilite">40</span></td>
|
|
<td class="resultValueCell"> <span class="add_hilite">42</span></td>
|
|
<td class="resultValueCell"> <span class="add_hilite">41</span></td>
|
|
</tr><tr><td class="resultLabelCellRight popFlowLabelCell popFlowLabelCompleted"> <span class="add_hilite">Completed</span></td>
|
|
<td class="resultValueCell"> <span class="add_hilite">32</span></td>
|
|
<td class="resultValueCell"> <span class="add_hilite">38</span></td>
|
|
<td class="resultValueCell"> <span class="add_hilite">35</span></td>
|
|
</tr><tr><td class="resultLabelCellRight popFlowLabelCell popFlowLabelCompleted"> <span class="add_hilite">Not Completed</span></td>
|
|
<td class="resultValueCell"> <span class="add_hilite">8</span></td>
|
|
<td class="resultValueCell"> <span class="add_hilite">4</span></td>
|
|
<td class="resultValueCell"> <span class="add_hilite">6</span></td>
|
|
</tr><tr><td class="resultLabelCellRight popFlowLabelCell"><span style="margin-left:1em;opacity:50%;font-weight:bold;">Reason Not Completed</span></td><td class="resultValueCell"></td><td class="resultValueCell"></td><td class="resultValueCell"></td></tr>
|
|
<tr><td class="resultLabelCellRight popFlowLabelCell" style="padding-left: 2em;"> <span class="add_hilite">Adverse Event</span></td>
|
|
<td class="resultValueCell popFlowValueNotCompleted"> <span class="add_hilite">5</span></td>
|
|
<td class="resultValueCell popFlowValueNotCompleted"> <span class="add_hilite">2</span></td>
|
|
<td class="resultValueCell popFlowValueNotCompleted"> <span class="add_hilite">3</span></td>
|
|
</tr><tr><td class="resultLabelCellRight popFlowLabelCell" style="padding-left: 2em;"> <span class="add_hilite">Voluntary Withdrawal of Consent</span></td>
|
|
<td class="resultValueCell popFlowValueNotCompleted"> <span class="add_hilite">2</span></td>
|
|
<td class="resultValueCell popFlowValueNotCompleted"> <span class="add_hilite">0</span></td>
|
|
<td class="resultValueCell popFlowValueNotCompleted"> <span class="add_hilite">2</span></td>
|
|
</tr><tr><td class="resultLabelCellRight popFlowLabelCell" style="padding-left: 2em;"> <span class="add_hilite">Physician Decision</span></td>
|
|
<td class="resultValueCell popFlowValueNotCompleted"> <span class="add_hilite">0</span></td>
|
|
<td class="resultValueCell popFlowValueNotCompleted"> <span class="add_hilite">1</span></td>
|
|
<td class="resultValueCell popFlowValueNotCompleted"> <span class="add_hilite">0</span></td>
|
|
</tr><tr><td class="resultLabelCellRight popFlowLabelCell" style="padding-left: 2em;"> <span class="add_hilite">At Discretion of Sponsor</span></td>
|
|
<td class="resultValueCell popFlowValueNotCompleted"> <span class="add_hilite">1</span></td>
|
|
<td class="resultValueCell popFlowValueNotCompleted"> <span class="add_hilite">1</span></td>
|
|
<td class="resultValueCell popFlowValueNotCompleted"> <span class="add_hilite">1</span></td>
|
|
</tr></td></tr>
|
|
</tbody></table></td></tr>
|
|
</tbody>
|
|
</table>
|
|
</div>
|
|
</fieldset>
|
|
</div>
|
|
</form>
|
|
</td></tr>
|
|
<tr>
|
|
<td colspan=3>
|
|
<form id="form_BaselineCharacteristics"><a id="BaselineCharacteristics"></a><div><fieldset class="entryReq" style="margin:auto;margin-bottom:1em;width:98%;padding-bottom:0.5em;background-color:#F7F7F7;">
|
|
<legend class="moduleLabel"> <img id="BaselineCharacteristicsImg" class="toggleImage" onclick="toggleModule('BaselineCharacteristics');" src="html/images/collapse.png" alt='Open or close this module'>
|
|
Baseline Characteristics</legend>
|
|
<div id="BaselineCharacteristicsBody" class="moduleBody">
|
|
<table class="moduleTable resultTable" style="margin-top:0.5em;">
|
|
<thead>
|
|
<tr style="display:none;"><th style="width:250px;"></th><th></th></tr>
|
|
</thead>
|
|
<tbody>
|
|
<tr><td colspan="2" style="padding:0;"><table class="resultTable" style="width:100%;empty-cells:show;">
|
|
<thead><tr>
|
|
<th style="width:15%;"></th>
|
|
<th style="width:10%;"></th>
|
|
<th style="width:18%;"></th><th style="width:18%;"></th><th style="width:18%;"></th><th style="width:18%;"></th></tr></thead>
|
|
<tbody><tr><td class="resultLabelCellRight baselineLabelCell resultTopCell" style="min-width:350px;" colspan="2">Arm/Group Title</td><td class="resultLabelCell baselineLabelCell resultTopCell" style="text-align:center;"> <span class="add_hilite">Placebo</span></td><td class="resultLabelCell baselineLabelCell resultTopCell" style="text-align:center;"> <span class="add_hilite">10 mg</span></td><td class="resultLabelCell baselineLabelCell resultTopCell" style="text-align:center;"> <span class="add_hilite">20 mg</span></td><td class="resultLabelCell baselineLabelCell resultTopCell" style="text-align:center;"> <span class="add_hilite">Total</span></td></tr>
|
|
<tr><td class="resultLabelCellRight baselineLabelCell resultBottomCell" colspan="2">Arm/Group Description</td><td class="resultLabelCell baselineLabelCell resultBottomCell" style="text-align:left;"><span class="add_hilite">Placebo tablet, once daily by mouth, 6 weeks
|
|
</span>
|
|
</td><td class="resultLabelCell baselineLabelCell resultBottomCell" style="text-align:left;"><span class="add_hilite">Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
|
|
</span>
|
|
</td><td class="resultLabelCell baselineLabelCell resultBottomCell" style="text-align:left;"><span class="add_hilite">Pimavanserin tartrate (ACP-103) 20 mg, tablet, once daily by mouth, 6 weeks
|
|
</span>
|
|
</td><td class="resultLabelCell baselineLabelCell resultBottomCell" style="text-align:left;"><span class="add_hilite">Total of all reporting groups
|
|
</span>
|
|
</td></tr><tr><td class="resultLabelCellRight baselineLabelCell resultTopCell" colspan="2">Overall Number of Baseline <span class="add_hilite">Participants</span></td>
|
|
<td class="baselineValueCell resultTopCell"> <span class="add_hilite">39</span></td>
|
|
<td class="baselineValueCell resultTopCell"> <span class="add_hilite">41</span></td>
|
|
<td class="baselineValueCell resultTopCell"> <span class="add_hilite">41</span></td>
|
|
<td class="baselineValueCell resultTopCell"> <span class="add_hilite">121</span></td>
|
|
</tr>
|
|
<tr><td colspan="2" class=" resultLabelCellRight baselineLabelCell resultBottomCell">Baseline Analysis Population Description</td><td colspan="4" class="resultValueCellLeft baselineValueCell resultBottomCell">
|
|
[Not Specified]</td></tr>
|
|
<tr><td class="resultLabelCell baselineLabelCell resultTopCell resultBottomCell" rowspan="4"><span style="font-weight:bold;"> <span class="add_hilite">Age, Categorical</span></span><div style="font-size:smaller;padding-left:1em;margin-top:0.5em;">Measure Type: <span class="add_hilite">Count of Participants</span><br>Unit of measure: <span class="add_hilite">Participants</span></div></td><td class="resultLabelCellRight baselineLabelCell resultTopCell" style="font-size:smaller;">Number Analyzed</td><td class="baselineValueCell resultTopCell" style="font-size:smaller;"> <span class="add_hilite">39 Participants</span></td><td class="baselineValueCell resultTopCell" style="font-size:smaller;"> <span class="add_hilite">41 Participants</span></td><td class="baselineValueCell resultTopCell" style="font-size:smaller;"> <span class="add_hilite">41 Participants</span></td><td class="baselineValueCell resultTopCell" style="font-size:smaller;"> <span class="add_hilite">121 Participants</span></td></tr><tr><td class="resultLabelCellRight baselineLabelCell" style="font-size:smaller;"> <span class="add_hilite"><=18 years</span></td><td class="resultValueCell"><div class="percentHalf"> <span class="add_hilite">0</span></div><div class="percentHalf percentValue"> <span class="add_hilite">0%</span></div></td><td class="resultValueCell"><div class="percentHalf"> <span class="add_hilite">0</span></div><div class="percentHalf percentValue"> <span class="add_hilite">0%</span></div></td><td class="resultValueCell"><div class="percentHalf"> <span class="add_hilite">0</span></div><div class="percentHalf percentValue"> <span class="add_hilite">0%</span></div></td><td class="resultValueCell"><div class="percentHalf"> <span class="add_hilite">0</span></div><div class="percentHalf percentValue"> <span class="add_hilite">0%</span></div></td></tr>
|
|
<tr><td class="resultLabelCellRight baselineLabelCell" style="font-size:smaller;"> <span class="add_hilite">Between 18 and 65 years</span></td><td class="resultValueCell"><div class="percentHalf"> <span class="add_hilite">7</span></div><div class="percentHalf percentValue"> <span class="add_hilite">17.95%</span></div></td><td class="resultValueCell"><div class="percentHalf"> <span class="add_hilite">7</span></div><div class="percentHalf percentValue"> <span class="add_hilite">17.07%</span></div></td><td class="resultValueCell"><div class="percentHalf"> <span class="add_hilite">7</span></div><div class="percentHalf percentValue"> <span class="add_hilite">17.07%</span></div></td><td class="resultValueCell"><div class="percentHalf"> <span class="add_hilite">21</span></div><div class="percentHalf percentValue"> <span class="add_hilite">17.36%</span></div></td></tr>
|
|
<tr><td class="resultLabelCellRight baselineLabelCell resultBottomCell" style="font-size:smaller;"> <span class="add_hilite">>=65 years</span></td><td class="resultValueCell resultBottomCell"><div class="percentHalf"> <span class="add_hilite">32</span></div><div class="percentHalf percentValue"> <span class="add_hilite">82.05%</span></div></td><td class="resultValueCell resultBottomCell"><div class="percentHalf"> <span class="add_hilite">34</span></div><div class="percentHalf percentValue"> <span class="add_hilite">82.93%</span></div></td><td class="resultValueCell resultBottomCell"><div class="percentHalf"> <span class="add_hilite">34</span></div><div class="percentHalf percentValue"> <span class="add_hilite">82.93%</span></div></td><td class="resultValueCell resultBottomCell"><div class="percentHalf"> <span class="add_hilite">100</span></div><div class="percentHalf percentValue"> <span class="add_hilite">82.64%</span></div></td></tr>
|
|
<tr><td class="resultLabelCell baselineLabelCell resultTopCell resultBottomCell" rowspan="2"><span style="font-weight:bold;"> <span class="add_hilite">Age, Continuous</span></span><div style="font-size:smaller;padding-left:1em;margin-top:0.5em;"> <span class="add_hilite">Mean</span> ( <span class="add_hilite">Standard Deviation</span>)<br>Unit of measure: <span class="add_hilite">years</span></div></td><td class="resultLabelCellRight baselineLabelCell resultTopCell" style="font-size:smaller;">Number Analyzed</td><td class="baselineValueCell resultTopCell" style="font-size:smaller;"> <span class="add_hilite">39 Participants</span></td><td class="baselineValueCell resultTopCell" style="font-size:smaller;"> <span class="add_hilite">41 Participants</span></td><td class="baselineValueCell resultTopCell" style="font-size:smaller;"> <span class="add_hilite">41 Participants</span></td><td class="baselineValueCell resultTopCell" style="font-size:smaller;"> <span class="add_hilite">121 Participants</span></td></tr><tr><td class="resultLabelCellRight baselineLabelCell resultBottomCell" style="font-size:smaller;"></td><td class="resultValueCell resultBottomCell"> <span class="add_hilite">73.0</span> <span class="add_hilite"><span style="margin-left:0.5em;">(7.91)</span></span></td><td class="resultValueCell resultBottomCell"> <span class="add_hilite">71.0</span> <span class="add_hilite"><span style="margin-left:0.5em;">(7.44)</span></span></td><td class="resultValueCell resultBottomCell"> <span class="add_hilite">72.1</span> <span class="add_hilite"><span style="margin-left:0.5em;">(8.15)</span></span></td><td class="resultValueCell resultBottomCell"> <span class="add_hilite">72.0</span> <span class="add_hilite"><span style="margin-left:0.5em;">(7.82)</span></span></td></tr>
|
|
<tr><td class="resultLabelCell baselineLabelCell resultTopCell resultBottomCell" rowspan="3"><span style="font-weight:bold;"> <span class="add_hilite">Sex: Female, Male</span></span><div style="font-size:smaller;padding-left:1em;margin-top:0.5em;">Measure Type: <span class="add_hilite">Count of Participants</span><br>Unit of measure: <span class="add_hilite">Participants</span></div></td><td class="resultLabelCellRight baselineLabelCell resultTopCell" style="font-size:smaller;">Number Analyzed</td><td class="baselineValueCell resultTopCell" style="font-size:smaller;"> <span class="add_hilite">39 Participants</span></td><td class="baselineValueCell resultTopCell" style="font-size:smaller;"> <span class="add_hilite">41 Participants</span></td><td class="baselineValueCell resultTopCell" style="font-size:smaller;"> <span class="add_hilite">41 Participants</span></td><td class="baselineValueCell resultTopCell" style="font-size:smaller;"> <span class="add_hilite">121 Participants</span></td></tr><tr><td class="resultLabelCellRight baselineLabelCell" style="font-size:smaller;"> <span class="add_hilite">Female</span></td><td class="resultValueCell"><div class="percentHalf"> <span class="add_hilite">12</span></div><div class="percentHalf percentValue"> <span class="add_hilite">30.77%</span></div></td><td class="resultValueCell"><div class="percentHalf"> <span class="add_hilite">15</span></div><div class="percentHalf percentValue"> <span class="add_hilite">36.59%</span></div></td><td class="resultValueCell"><div class="percentHalf"> <span class="add_hilite">17</span></div><div class="percentHalf percentValue"> <span class="add_hilite">41.46%</span></div></td><td class="resultValueCell"><div class="percentHalf"> <span class="add_hilite">44</span></div><div class="percentHalf percentValue"> <span class="add_hilite">36.36%</span></div></td></tr>
|
|
<tr><td class="resultLabelCellRight baselineLabelCell resultBottomCell" style="font-size:smaller;"> <span class="add_hilite">Male</span></td><td class="resultValueCell resultBottomCell"><div class="percentHalf"> <span class="add_hilite">27</span></div><div class="percentHalf percentValue"> <span class="add_hilite">69.23%</span></div></td><td class="resultValueCell resultBottomCell"><div class="percentHalf"> <span class="add_hilite">26</span></div><div class="percentHalf percentValue"> <span class="add_hilite">63.41%</span></div></td><td class="resultValueCell resultBottomCell"><div class="percentHalf"> <span class="add_hilite">24</span></div><div class="percentHalf percentValue"> <span class="add_hilite">58.54%</span></div></td><td class="resultValueCell resultBottomCell"><div class="percentHalf"> <span class="add_hilite">77</span></div><div class="percentHalf percentValue"> <span class="add_hilite">63.64%</span></div></td></tr>
|
|
<tr><td class="resultLabelCell baselineLabelCell resultTopCell" rowspan="1"><span style="font-weight:bold;"> <span class="add_hilite">Region of Enrollment</span></span><div style="font-size:smaller;padding-left:1em;margin-top:0.5em;">Measure Type: <span class="add_hilite">Number</span><br>Unit of measure: <span class="add_hilite">participants</span></div></td><td class="resultLabelCellRight baselineLabelCell resultTopCell" style="font-size:smaller;">Number Analyzed</td><td class="baselineValueCell resultTopCell" style="font-size:smaller;"> <span class="add_hilite">39 Participants</span></td><td class="baselineValueCell resultTopCell" style="font-size:smaller;"> <span class="add_hilite">41 Participants</span></td><td class="baselineValueCell resultTopCell" style="font-size:smaller;"> <span class="add_hilite">41 Participants</span></td><td class="baselineValueCell resultTopCell" style="font-size:smaller;"> <span class="add_hilite">121 Participants</span></td></tr><tr><td class="resultLabelCell baselineLabelCell"><div style="text-align:right"> <span class="add_hilite">United States</span></div></td><td class="resultLabelCellRight baselineLabelCell" style="font-size:smaller;"></td><td class="resultValueCell"> <span class="add_hilite">18</span></td><td class="resultValueCell"> <span class="add_hilite">17</span></td><td class="resultValueCell"> <span class="add_hilite">18</span></td><td class="resultValueCell"> <span class="add_hilite">53</span></td></tr>
|
|
<tr><td class="resultLabelCell baselineLabelCell resultBottomCell"><div style="text-align:right"> <span class="add_hilite">Europe</span></div></td><td class="resultLabelCellRight baselineLabelCell resultBottomCell" style="font-size:smaller;"></td><td class="resultValueCell resultBottomCell"> <span class="add_hilite">21</span></td><td class="resultValueCell resultBottomCell"> <span class="add_hilite">24</span></td><td class="resultValueCell resultBottomCell"> <span class="add_hilite">23</span></td><td class="resultValueCell resultBottomCell"> <span class="add_hilite">68</span></td></tr>
|
|
</tbody></table></div></td></tr>
|
|
</tbody>
|
|
</table>
|
|
</div>
|
|
</fieldset>
|
|
</div>
|
|
</form>
|
|
</td></tr>
|
|
<tr>
|
|
<td colspan=3>
|
|
<form id="form_ROutcomeMeasures"><a id="ROutcomeMeasures"></a><div><fieldset class="entryReq" style="margin:auto;margin-bottom:1em;width:98%;padding-bottom:0.5em;background-color:#F7F7F7;">
|
|
<legend class="moduleLabel"> <img id="ROutcomeMeasuresImg" class="toggleImage" onclick="toggleModule('ROutcomeMeasures');" src="html/images/collapse.png" alt='Open or close this module'>
|
|
Outcome Measures</legend>
|
|
<div id="ROutcomeMeasuresBody" class="moduleBody">
|
|
<table class="moduleTable resultTable" style="margin-top:0.5em;">
|
|
<thead>
|
|
<tr style="display:none;"><th style="width:250px;"></th><th></th></tr>
|
|
</thead>
|
|
<tbody>
|
|
<tr><td colspan="2"><fieldset class="resultOMFieldset"><legend class="resultOMLegend"> <span class="add_hilite">1. Primary</span> Outcome:</legend><div style="padding:1em;overflow-x:auto;background-color:#FFFFFF;"><table class="moduleTable resultTable" style="width:100%;">
|
|
<thead>
|
|
<tr style="display:none;"><th style="width:250px;"></th><th style="width:100%;"></th></tr>
|
|
</thead>
|
|
<tbody>
|
|
<tr style="vertical-align:top;">
|
|
<td class="resultLabelCellRight outcomeLabelCell" style="min-width: 250px;">Title</td>
|
|
<td class="resultCell" style="width:100%"> <span class="add_hilite">Antipsychotic Efficacy</span></td></tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="resultLabelCellRight outcomeLabelCell" style="min-width: 250px;">Description</td>
|
|
<td class="resultValueCellLeft" style="text-align:left;width:100%"><p><span class="add_hilite">Antipsychotic efficacy was defined as a decrease in the severity and/or frequency of hallucinations and/or delusions. This is measured as the change from baseline (Day 1) to Day 42 in the Scale for the Assessment of Positive Symptoms - Hallucinations and Delusions scales (SAPS-H+D) score for the ITT Analysis Set. The possible total score is 1 to 100 and a negative change in score indicates improvement.
|
|
</span></p>
|
|
|
|
<p><span class="add_hilite">Analysis Method: Analysis of Covariance (ANCOVA) and missing data was imputed using Last Observation Carried Forward (LOCF) method.
|
|
</span></p>
|
|
|
|
</td></tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="resultLabelCellRight outcomeLabelCell" style="min-width: 250px;">Time Frame</td>
|
|
<td class="resultValueCellLeft" style="text-align:left;width:100%"> <span class="add_hilite">Each study visit (i.e. Days 1, 8, 15, 29 and 42)</span></td></tr>
|
|
<tr><td style="padding:1em 0;" colspan="2">Outcome Measure Data</td></tr><tr><td class="resultLabelCell outcomeLabelCell" colspan="2">Analysis Population Description</td></tr>
|
|
<tr><td class="resultCell" colspan="2"><span class="add_hilite">This is the "Intent to Treat" population, defined as patients who received at least one dose of study drug and had both the baseline SAPS assessment and at least one post-baseline SAPS assessment.
|
|
</span>
|
|
</td></tr>
|
|
<tr><td colspan="2" style="padding:0;"><div class="BigTableWrapper">
|
|
<table class="resultTable" style="margin-top:1em;empty-cells:show;width:99.9%;">
|
|
<thead><tr style="visibility:hidden;">
|
|
<th class="resultLabelCell" style="width:15%;max-width:250px;border-width:0;"> </th>
|
|
<th></th><th></th><th></th></tr></thead>
|
|
<tbody><tr><td class="resultLabelCellRight outcomeLabelCell" style="min-width:250px" colspan="1">Arm/Group Title</td><td class="resultLabelCell outcomeLabelCell" style="text-align:center;width:25%;"> <span class="add_hilite">Placebo</span></td><td class="resultLabelCell outcomeLabelCell" style="text-align:center;width:25%;"> <span class="add_hilite">Pimavanserin 10 mg</span></td><td class="resultLabelCell outcomeLabelCell" style="text-align:center;width:25%;"> <span class="add_hilite">Pimavanserin 20 mg</span></td><tr><td class="resultLabelCellRight outcomeLabelCell" colspan="1">Arm/Group Description</td><td class="resultLabelCell outcomeLabelCell" style="text-align:left;"><span class="add_hilite">Placebo tablet, once daily by mouth, 6 weeks
|
|
</span>
|
|
</td><td class="resultLabelCell outcomeLabelCell" style="text-align:left;"><span class="add_hilite">Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
|
|
</span>
|
|
</td><td class="resultLabelCell outcomeLabelCell" style="text-align:left;"><span class="add_hilite">Pimavanserin tartrate (ACP-103) 20 mg, tablet, once daily by mouth, 6 weeks
|
|
</span>
|
|
</td></tr><tr><td class="resultLabelCellRight outcomeLabelCell" colspan="1">Overall Number of Participants Analyzed</td><td class="resultValueCell"> <span class="add_hilite">38</span></td>
|
|
<td class="resultValueCell"> <span class="add_hilite">38</span></td>
|
|
<td class="resultValueCell"> <span class="add_hilite">41</span></td>
|
|
</tr>
|
|
<tr><td class="resultLabelCellRight outcomeLabelCell" rowspan="1"><div style="font-size:smaller;"> <span class="add_hilite">Least Squares Mean (95% Confidence Interval)</span><br>Unit of Measure: <span class="add_hilite">Scores on the SAPS H+D scale</span></div></td><td class="resultValueCell"></td><td class="resultValueCell"></td><td class="resultValueCell"></td></tr>
|
|
<tr><td class="resultLabelCell outcomeLabelCell"><div style="text-align:right"> <span class="add_hilite">Change from Baseline</span></div></td><td class="resultValueCell"> <span class="add_hilite">-4.4</span> <span class="add_hilite"><span style="margin-left:0.5em;">(-6.5 to -2.3)</span></span></td>
|
|
<td class="resultValueCell"> <span class="add_hilite">NA</span> <span class="add_hilite"><span style="margin-left:0.5em;">(NA to NA)</span><sup class="commentOutcomeIndex"> [1]</sup></span></td>
|
|
<td class="resultValueCell"> <span class="add_hilite">-6.5</span> <span class="add_hilite"><span style="margin-left:0.5em;">(-8.5 to -4.5)</span></span></td>
|
|
</tr>
|
|
<tr><td class="resultLabelCell outcomeLabelCell"><div style="text-align:right"> <span class="add_hilite">Difference of Least Squares Mean versus Placebo</span></div></td><td class="resultValueCell"> <span class="add_hilite">NA</span> <span class="add_hilite"><span style="margin-left:0.5em;">(NA to NA)</span><sup class="commentOutcomeIndex"> [2]</sup></span></td>
|
|
<td class="resultValueCell"> <span class="add_hilite">NA</span> <span class="add_hilite"><span style="margin-left:0.5em;">(NA to NA)</span><sup class="commentOutcomeIndex"> [1]</sup></span></td>
|
|
<td class="resultValueCell"> <span class="add_hilite">-2.1</span> <span class="add_hilite"><span style="margin-left:0.5em;">(-4.9 to 0.8)</span></span></td>
|
|
</tr>
|
|
</tbody></table></div></td></tr>
|
|
<tr><td colspan="4"><table style="border-collapse:collapse;border-width:0;table-layout:fixed;width:100%;"><tbody><tr><td style="width:3em;text-align:center;vertical-align:text-top;"><span class="commentOutcomeIndex">[1]</span></td><td style="text-align:left;"> <span class="add_hilite">NA Explanation: </span><span class="add_hilite">Only the high dose comparison was incorporated in the ANCOVA model analysis following the early termination of the study. The prospective SAP eliminated the analysis of the low dose, 10 mg arm.
|
|
</span>
|
|
</td></tr>
|
|
<tr><td style="width:3em;text-align:center;vertical-align:text-top;"><span class="commentOutcomeIndex">[2]</span></td><td style="text-align:left;"> <span class="add_hilite">NA Explanation: </span><span class="add_hilite">Calculation is a comparison of active arm versus placebo.
|
|
</span>
|
|
</td></tr>
|
|
</tbody></table></td></tr>
|
|
</tbody></table></div></fieldset></td></tr>
|
|
<tr><td colspan="2"><fieldset class="resultOMFieldset"><legend class="resultOMLegend"> <span class="add_hilite">2. Secondary</span> Outcome:</legend><div style="padding:1em;overflow-x:auto;background-color:#FFFFFF;"><table class="moduleTable resultTable" style="width:100%;">
|
|
<thead>
|
|
<tr style="display:none;"><th style="width:250px;"></th><th style="width:100%;"></th></tr>
|
|
</thead>
|
|
<tbody>
|
|
<tr style="vertical-align:top;">
|
|
<td class="resultLabelCellRight outcomeLabelCell" style="min-width: 250px;">Title</td>
|
|
<td class="resultCell" style="width:100%"> <span class="add_hilite">Motor Symptoms Change From Baseline (Negative = Improvement)</span></td></tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="resultLabelCellRight outcomeLabelCell" style="min-width: 250px;">Description</td>
|
|
<td class="resultValueCellLeft" style="text-align:left;width:100%"><p><span class="add_hilite">Motor symptoms were measured using the change from baseline (Day 1) to Day 42 in the combined score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) and Part III (Motor Examination). The total possible score is 0 to 160 and a negative change in score indicates improvement.
|
|
</span></p>
|
|
|
|
<p><span class="add_hilite">Analysis Method: ANCOVA, and missing data was imputed using LOCF method. The UPDRS Parts II+III score was analyzed by constructing 2-sided 95% confidence intervals (CIs) on the difference between each pimavanserin dose group and placebo mean change from baseline. Non-inferiority was concluded if the upper limit of the CI was less than or equal to 5.
|
|
</span></p>
|
|
|
|
</td></tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="resultLabelCellRight outcomeLabelCell" style="min-width: 250px;">Time Frame</td>
|
|
<td class="resultValueCellLeft" style="text-align:left;width:100%"> <span class="add_hilite">Each study visit (i.e. Days 1, 8, 15, 29 and 42)</span></td></tr>
|
|
<tr><td style="padding:1em 0;" colspan="2">Outcome Measure Data</td></tr><tr><td class="resultLabelCell outcomeLabelCell" colspan="2">Analysis Population Description</td></tr>
|
|
<tr><td class="resultCell" colspan="2"><span class="add_hilite">This is the "Intent to Treat" population, defined as patients who received at least one dose of study drug and had both the baseline SAPS assessment and at least one post-baseline SAPS assessment.
|
|
</span>
|
|
</td></tr>
|
|
<tr><td colspan="2" style="padding:0;"><div class="BigTableWrapper">
|
|
<table class="resultTable" style="margin-top:1em;empty-cells:show;width:99.9%;">
|
|
<thead><tr style="visibility:hidden;">
|
|
<th class="resultLabelCell" style="width:15%;max-width:250px;border-width:0;"> </th>
|
|
<th></th><th></th><th></th></tr></thead>
|
|
<tbody><tr><td class="resultLabelCellRight outcomeLabelCell" style="min-width:250px" colspan="1">Arm/Group Title</td><td class="resultLabelCell outcomeLabelCell" style="text-align:center;width:25%;"> <span class="add_hilite">Placebo</span></td><td class="resultLabelCell outcomeLabelCell" style="text-align:center;width:25%;"> <span class="add_hilite">Pimavanserin 10 mg</span></td><td class="resultLabelCell outcomeLabelCell" style="text-align:center;width:25%;"> <span class="add_hilite">Pimavanserin 20 mg</span></td><tr><td class="resultLabelCellRight outcomeLabelCell" colspan="1">Arm/Group Description</td><td class="resultLabelCell outcomeLabelCell" style="text-align:left;"><span class="add_hilite">Placebo tablet, once daily by mouth, 6 weeks
|
|
</span>
|
|
</td><td class="resultLabelCell outcomeLabelCell" style="text-align:left;"><span class="add_hilite">Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
|
|
</span>
|
|
</td><td class="resultLabelCell outcomeLabelCell" style="text-align:left;"><span class="add_hilite">Pimavanserin tartrate (ACP-103) 20 mg, tablet, once daily by mouth, 6 weeks
|
|
</span>
|
|
</td></tr><tr><td class="resultLabelCellRight outcomeLabelCell" colspan="1">Overall Number of Participants Analyzed</td><td class="resultValueCell"> <span class="add_hilite">38</span></td>
|
|
<td class="resultValueCell"> <span class="add_hilite">38</span></td>
|
|
<td class="resultValueCell"> <span class="add_hilite">41</span></td>
|
|
</tr>
|
|
<tr><td class="resultLabelCellRight outcomeLabelCell" rowspan="1"><div style="font-size:smaller;"> <span class="add_hilite">Least Squares Mean (95% Confidence Interval)</span><br>Unit of Measure: <span class="add_hilite">Score on UPDRS-II+III scale.</span></div></td><td class="resultValueCell"></td><td class="resultValueCell"></td><td class="resultValueCell"></td></tr>
|
|
<tr><td class="resultLabelCell outcomeLabelCell"><div style="text-align:right"> <span class="add_hilite">Change from Baseline</span></div></td><td class="resultValueCell"> <span class="add_hilite">-1.8</span> <span class="add_hilite"><span style="margin-left:0.5em;">(-4.6 to 1.0)</span></span></td>
|
|
<td class="resultValueCell"> <span class="add_hilite">NA</span> <span class="add_hilite"><span style="margin-left:0.5em;">(NA to NA)</span><sup class="commentOutcomeIndex"> [1]</sup></span></td>
|
|
<td class="resultValueCell"> <span class="add_hilite">-3.9</span> <span class="add_hilite"><span style="margin-left:0.5em;">(-6.6 to -1.2)</span></span></td>
|
|
</tr>
|
|
<tr><td class="resultLabelCell outcomeLabelCell"><div style="text-align:right"> <span class="add_hilite">Difference of Least Squares Mean versus Placebo</span></div></td><td class="resultValueCell"> <span class="add_hilite">NA</span> <span class="add_hilite"><span style="margin-left:0.5em;">(NA to NA)</span><sup class="commentOutcomeIndex"> [2]</sup></span></td>
|
|
<td class="resultValueCell"> <span class="add_hilite">NA</span> <span class="add_hilite"><span style="margin-left:0.5em;">(NA to NA)</span><sup class="commentOutcomeIndex"> [1]</sup></span></td>
|
|
<td class="resultValueCell"> <span class="add_hilite">-2.1</span> <span class="add_hilite"><span style="margin-left:0.5em;">(-5.9 to 1.8)</span></span></td>
|
|
</tr>
|
|
</tbody></table></div></td></tr>
|
|
<tr><td colspan="4"><table style="border-collapse:collapse;border-width:0;table-layout:fixed;width:100%;"><tbody><tr><td style="width:3em;text-align:center;vertical-align:text-top;"><span class="commentOutcomeIndex">[1]</span></td><td style="text-align:left;"> <span class="add_hilite">NA Explanation: </span><span class="add_hilite">Only the high dose comparison was incorporated in the ANCOVA model analysis following the early termination of the study. The prospective SAP eliminated the analysis of the low dose, 10 mg arm.
|
|
</span>
|
|
</td></tr>
|
|
<tr><td style="width:3em;text-align:center;vertical-align:text-top;"><span class="commentOutcomeIndex">[2]</span></td><td style="text-align:left;"> <span class="add_hilite">NA Explanation: </span><span class="add_hilite">Calculation is a comparison of active arm versus placebo.
|
|
</span>
|
|
</td></tr>
|
|
</tbody></table></td></tr>
|
|
</tbody></table></div></fieldset></td></tr>
|
|
</tbody>
|
|
</table>
|
|
</div>
|
|
</fieldset>
|
|
</div>
|
|
</form>
|
|
</td></tr>
|
|
<tr>
|
|
<td colspan=3>
|
|
<form id="form_AdverseEvents"><a id="AdverseEvents"></a><div><fieldset class="entryReq" style="margin:auto;margin-bottom:1em;width:98%;padding-bottom:0.5em;background-color:#F7F7F7;">
|
|
<legend class="moduleLabel"> <img id="AdverseEventsImg" class="toggleImage" onclick="toggleModule('AdverseEvents');" src="html/images/collapse.png" alt='Open or close this module'>
|
|
Adverse Events</legend>
|
|
<div id="AdverseEventsBody" class="moduleBody">
|
|
<table class="moduleTable resultTable" style="margin-top:0.5em;">
|
|
<thead>
|
|
<tr style="display:none;"><th style="width:250px;"></th><th></th></tr>
|
|
</thead>
|
|
<tbody>
|
|
<tr><td colspan=2 style="padding:0;"><table class="resultTable" style="width:100%;">
|
|
<thead style="display:none;"><tr><th class="resultLabelCell labelCellAdEv"> </th><th class="resultLabelCell labelCellAdEv resultBottomCell" style="width:16%"></th><th class="resultLabelCell labelCellAdEv resultBottomCell" style="width:8%"></th><th class="resultLabelCell labelCellAdEv resultBottomCell" style="width:16%"></th><th class="resultLabelCell labelCellAdEv resultBottomCell" style="width:8%"></th><th class="resultLabelCell labelCellAdEv resultBottomCell" style="width:16%"></th><th class="resultLabelCell labelCellAdEv resultBottomCell" style="width:8%"></th></tr></thead><tbody> <tr style="vertical-align:top;">
|
|
<td class="resultLabelCellRight labelCellAdEv resultTopCell" style="min-width: 300px;">Time Frame</td>
|
|
<td class="resultValueCellLeft resultTopCell" colspan="6"> <span class="add_hilite">6 weeks</span></td></tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="resultLabelCellRight labelCellAdEv resultBottomCell" style="min-width: 25%;">Adverse Event Reporting Description</td>
|
|
<td class="resultValueCell resultBottomCell" style="text-align:left;" colspan="6"><span class="add_hilite">From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 8, 15, 29, 42 and Day 70 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.
|
|
</span>
|
|
</td></tr>
|
|
<tr><td colspan="7" style="padding-top:1em;border-width:0;"> </td></tr>
|
|
<tr>
|
|
<td class="resultLabelCellRight labelCellAdEv resultTopCell">Arm/Group Title</td>
|
|
<td class="resultValueCell resultTopCell" style="text-align:center;" colspan="2"> <span class="add_hilite">Placebo</span></td>
|
|
<td class="resultValueCell resultTopCell" style="text-align:center;" colspan="2"> <span class="add_hilite">Pimavanserin 10 mg</span></td>
|
|
<td class="resultValueCell resultTopCell" style="text-align:center;" colspan="2"> <span class="add_hilite">Pimavanserin 20 mg</span></td>
|
|
</tr>
|
|
<tr><td class="resultLabelCellRight labelCellAdEv resultBottomCell">Arm/Group Description</td>
|
|
<td class="resultValueCellLeft resultTopCell resultBottomCell" colspan="2"><span class="add_hilite">Placebo tablet, once daily by mouth, 6 weeks
|
|
</span>
|
|
</td>
|
|
<td class="resultValueCellLeft resultTopCell resultBottomCell" colspan="2"><span class="add_hilite">Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
|
|
</span>
|
|
</td>
|
|
<td class="resultValueCellLeft resultTopCell resultBottomCell" colspan="2"><span class="add_hilite">Pimavanserin tartrate (ACP-103) 20 mg, tablet, once daily by mouth, 6 weeks
|
|
</span>
|
|
</td>
|
|
</tr>
|
|
<tr><td colspan="7" style="padding-top:1em;font-weight:bold;">All-Cause Mortality</td></tr>
|
|
<tr><td class="resultLabelCell labelCellAdEv resultTopCell"> </td>
|
|
<td class="resultLabelCell labelCellAdEv resultTopCell" style="text-align:center;" colspan="2"><span style="font-weight:bold;"> <span class="add_hilite">Placebo</span></span></td><td class="resultLabelCell labelCellAdEv resultTopCell" style="text-align:center;" colspan="2"><span style="font-weight:bold;"> <span class="add_hilite">Pimavanserin 10 mg</span></span></td><td class="resultLabelCell labelCellAdEv resultTopCell" style="text-align:center;" colspan="2"><span style="font-weight:bold;"> <span class="add_hilite">Pimavanserin 20 mg</span></span></td></tr>
|
|
<tr><td class="resultLabelCell labelCellAdEv resultBottomCell"> </td><td class="resultLabelCell labelCellAdEv resultBottomCell" dataCellAdEv" style="text-align:center;font-size:smaller;vertical-align:middle;">Affected / At Risk (%)</td><td class="resultLabelCell labelCellAdEv resultBottomCell" style="text-align:center;font-size:smaller;vertical-align:middle;"># Events</td>
|
|
<td class="resultLabelCell labelCellAdEv resultBottomCell" dataCellAdEv" style="text-align:center;font-size:smaller;vertical-align:middle;">Affected / At Risk (%)</td><td class="resultLabelCell labelCellAdEv resultBottomCell" style="text-align:center;font-size:smaller;vertical-align:middle;"># Events</td>
|
|
<td class="resultLabelCell labelCellAdEv resultBottomCell" dataCellAdEv" style="text-align:center;font-size:smaller;vertical-align:middle;">Affected / At Risk (%)</td><td class="resultLabelCell labelCellAdEv resultBottomCell" style="text-align:center;font-size:smaller;vertical-align:middle;"># Events</td>
|
|
</tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="resultLabelCellRight labelCellAdEv resultTopCell resultBottomCell" style="min-width: 250px;">Total</td>
|
|
<td class="resultValueCell resultTopCell resultBottomCell dataCellAdEv"> / </td><td class="resultValueCell resultTopCell resultBottomCell"></td><td class="resultValueCell resultTopCell resultBottomCell dataCellAdEv"> / </td><td class="resultValueCell resultTopCell resultBottomCell"></td><td class="resultValueCell resultTopCell resultBottomCell dataCellAdEv"> / </td><td class="resultValueCell resultTopCell resultBottomCell"></td></tr>
|
|
<tr><td colspan="7" class="resultTopCell resultBottomCell" style="padding-top:1em;font-weight:bold;">Serious Adverse Events</td></tr>
|
|
<tr><td class="resultLabelCell labelCellAdEv resultTopCell"> </td>
|
|
<td class="resultLabelCell labelCellAdEv resultTopCell" style="text-align:center;" colspan="2"><span style="font-weight:bold;"> <span class="add_hilite">Placebo</span></span></td><td class="resultLabelCell labelCellAdEv resultTopCell" style="text-align:center;" colspan="2"><span style="font-weight:bold;"> <span class="add_hilite">Pimavanserin 10 mg</span></span></td><td class="resultLabelCell labelCellAdEv resultTopCell" style="text-align:center;" colspan="2"><span style="font-weight:bold;"> <span class="add_hilite">Pimavanserin 20 mg</span></span></td></tr>
|
|
<tr><td class="resultLabelCell labelCellAdEv resultBottomCell"> </td><td class="resultLabelCell labelCellAdEv resultBottomCell" dataCellAdEv" style="text-align:center;font-size:smaller;vertical-align:middle;">Affected / At Risk (%)</td><td class="resultLabelCell labelCellAdEv resultBottomCell" style="text-align:center;font-size:smaller;vertical-align:middle;"># Events</td>
|
|
<td class="resultLabelCell labelCellAdEv resultBottomCell" dataCellAdEv" style="text-align:center;font-size:smaller;vertical-align:middle;">Affected / At Risk (%)</td><td class="resultLabelCell labelCellAdEv resultBottomCell" style="text-align:center;font-size:smaller;vertical-align:middle;"># Events</td>
|
|
<td class="resultLabelCell labelCellAdEv resultBottomCell" dataCellAdEv" style="text-align:center;font-size:smaller;vertical-align:middle;">Affected / At Risk (%)</td><td class="resultLabelCell labelCellAdEv resultBottomCell" style="text-align:center;font-size:smaller;vertical-align:middle;"># Events</td>
|
|
</tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="resultLabelCellRight labelCellAdEv resultTopCell resultBottomCell" style="min-width: 250px;">Total</td>
|
|
<td class="resultValueCell resultTopCell resultBottomCell dataCellAdEv"> <span class="add_hilite">2</span> / <span class="add_hilite">39</span> ( <span class="add_hilite">5.13%</span>)</td><td class="resultValueCell resultTopCell resultBottomCell"></td><td class="resultValueCell resultTopCell resultBottomCell dataCellAdEv"> <span class="add_hilite">3</span> / <span class="add_hilite">41</span> ( <span class="add_hilite">7.32%</span>)</td><td class="resultValueCell resultTopCell resultBottomCell"></td><td class="resultValueCell resultTopCell resultBottomCell dataCellAdEv"> <span class="add_hilite">1</span> / <span class="add_hilite">41</span> ( <span class="add_hilite">2.44%</span>)</td><td class="resultValueCell resultTopCell resultBottomCell"></td></tr>
|
|
<tr><td class="resultLabelCell labelCellAdEv resultTopCell" colspan="7"> <span class="add_hilite">Infections and infestations</span></td></tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="resultLabelCellRight labelCellAdEv" style="min-width: 250px;"> <span class="add_hilite">Gastroenteritis <sup class="commentAdEvIndex">† A </sup></span></td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">1</span> / <span class="add_hilite">39</span> ( <span class="add_hilite">2.56%</span>)</td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">1</span></td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span> / <span class="add_hilite">41</span> ( <span class="add_hilite">0%</span>)</td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span></td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span> / <span class="add_hilite">41</span> ( <span class="add_hilite">0%</span>)</td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span></td></tr>
|
|
<tr><td class="resultLabelCell labelCellAdEv resultTopCell" colspan="7"> <span class="add_hilite">Injury, poisoning and procedural complications</span></td></tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="resultLabelCellRight labelCellAdEv" style="min-width: 250px;"> <span class="add_hilite">Fall <sup class="commentAdEvIndex">† A </sup></span></td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span> / <span class="add_hilite">39</span> ( <span class="add_hilite">0%</span>)</td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span></td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">1</span> / <span class="add_hilite">41</span> ( <span class="add_hilite">2.44%</span>)</td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">1</span></td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span> / <span class="add_hilite">41</span> ( <span class="add_hilite">0%</span>)</td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span></td></tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="resultLabelCellRight labelCellAdEv" style="min-width: 250px;"> <span class="add_hilite">Hip fracture <sup class="commentAdEvIndex">† A </sup></span></td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span> / <span class="add_hilite">39</span> ( <span class="add_hilite">0%</span>)</td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span></td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">1</span> / <span class="add_hilite">41</span> ( <span class="add_hilite">2.44%</span>)</td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">1</span></td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span> / <span class="add_hilite">41</span> ( <span class="add_hilite">0%</span>)</td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span></td></tr>
|
|
<tr><td class="resultLabelCell labelCellAdEv resultTopCell" colspan="7"> <span class="add_hilite">Nervous system disorders</span></td></tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="resultLabelCellRight labelCellAdEv" style="min-width: 250px;"> <span class="add_hilite">Parkinson's disease <sup class="commentAdEvIndex">† A </sup></span></td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span> / <span class="add_hilite">39</span> ( <span class="add_hilite">0%</span>)</td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span></td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span> / <span class="add_hilite">41</span> ( <span class="add_hilite">0%</span>)</td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span></td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">1</span> / <span class="add_hilite">41</span> ( <span class="add_hilite">2.44%</span>)</td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">1</span></td></tr>
|
|
<tr><td class="resultLabelCell labelCellAdEv resultTopCell" colspan="7"> <span class="add_hilite">Psychiatric disorders</span></td></tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="resultLabelCellRight labelCellAdEv" style="min-width: 250px;"> <span class="add_hilite">Delirium <sup class="commentAdEvIndex">† A </sup></span></td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">1</span> / <span class="add_hilite">39</span> ( <span class="add_hilite">2.56%</span>)</td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">1</span></td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span> / <span class="add_hilite">41</span> ( <span class="add_hilite">0%</span>)</td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span></td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span> / <span class="add_hilite">41</span> ( <span class="add_hilite">0%</span>)</td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span></td></tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="resultLabelCellRight labelCellAdEv" style="min-width: 250px;"> <span class="add_hilite">Delusion <sup class="commentAdEvIndex">† A </sup></span></td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span> / <span class="add_hilite">39</span> ( <span class="add_hilite">0%</span>)</td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span></td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">1</span> / <span class="add_hilite">41</span> ( <span class="add_hilite">2.44%</span>)</td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">2</span></td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span> / <span class="add_hilite">41</span> ( <span class="add_hilite">0%</span>)</td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span></td></tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="resultLabelCellRight labelCellAdEv" style="min-width: 250px;"> <span class="add_hilite">Delusional disorder, persecutory type <sup class="commentAdEvIndex">† A </sup></span></td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span> / <span class="add_hilite">39</span> ( <span class="add_hilite">0%</span>)</td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span></td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">1</span> / <span class="add_hilite">41</span> ( <span class="add_hilite">2.44%</span>)</td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">1</span></td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span> / <span class="add_hilite">41</span> ( <span class="add_hilite">0%</span>)</td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span></td></tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="resultLabelCellRight labelCellAdEv" style="min-width: 250px;"> <span class="add_hilite">Mental status changes <sup class="commentAdEvIndex">† A </sup></span></td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">1</span> / <span class="add_hilite">39</span> ( <span class="add_hilite">2.56%</span>)</td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">1</span></td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span> / <span class="add_hilite">41</span> ( <span class="add_hilite">0%</span>)</td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span></td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span> / <span class="add_hilite">41</span> ( <span class="add_hilite">0%</span>)</td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span></td></tr>
|
|
<tr><td colspan="7"><span class="commentAdEvIndex" style="font-weight:bold;margin-right:1em;">†</span> <span class="add_hilite">Indicates events were collected by systematic assessment.</span><br>
|
|
<span class="add_hilite"><span class="commentAdEvIndex" style="margin-right:1em;">A</span>Term from vocabulary, MedDRA (11.1)</span><br>
|
|
</td></tr>
|
|
<tr><td colspan="7" class="resultTopCell resultBottomCell" style="padding-top:1em;font-weight:bold;">Other (Not Including Serious) Adverse Events <tr style="vertical-align:top;">
|
|
<td class="resultLabelCellRight labelCellAdEv resultTopCell resultBottomCell" style="min-width: 250px;">Frequency Threshold for Reporting Other Adverse Events</td>
|
|
<td colspan="6" class="resultCell resultTopCell resultBottomCell"> <span class="add_hilite">5.00</span>%</td></tr>
|
|
<tr><td class="resultLabelCell labelCellAdEv resultTopCell"> </td>
|
|
<td class="resultLabelCell labelCellAdEv resultTopCell" style="text-align:center;" colspan="2"><span style="font-weight:bold;"> <span class="add_hilite">Placebo</span></span></td><td class="resultLabelCell labelCellAdEv resultTopCell" style="text-align:center;" colspan="2"><span style="font-weight:bold;"> <span class="add_hilite">Pimavanserin 10 mg</span></span></td><td class="resultLabelCell labelCellAdEv resultTopCell" style="text-align:center;" colspan="2"><span style="font-weight:bold;"> <span class="add_hilite">Pimavanserin 20 mg</span></span></td></tr>
|
|
<tr><td class="resultLabelCell labelCellAdEv resultBottomCell"> </td><td class="resultLabelCell labelCellAdEv resultBottomCell" dataCellAdEv" style="text-align:center;font-size:smaller;vertical-align:middle;">Affected / At Risk (%)</td><td class="resultLabelCell labelCellAdEv resultBottomCell" style="text-align:center;font-size:smaller;vertical-align:middle;"># Events</td>
|
|
<td class="resultLabelCell labelCellAdEv resultBottomCell" dataCellAdEv" style="text-align:center;font-size:smaller;vertical-align:middle;">Affected / At Risk (%)</td><td class="resultLabelCell labelCellAdEv resultBottomCell" style="text-align:center;font-size:smaller;vertical-align:middle;"># Events</td>
|
|
<td class="resultLabelCell labelCellAdEv resultBottomCell" dataCellAdEv" style="text-align:center;font-size:smaller;vertical-align:middle;">Affected / At Risk (%)</td><td class="resultLabelCell labelCellAdEv resultBottomCell" style="text-align:center;font-size:smaller;vertical-align:middle;"># Events</td>
|
|
</tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="resultLabelCellRight labelCellAdEv resultTopCell resultBottomCell" style="min-width: 250px;">Total</td>
|
|
<td class="resultValueCell resultTopCell resultBottomCell dataCellAdEv"> <span class="add_hilite">12</span> / <span class="add_hilite">39</span> ( <span class="add_hilite">30.77%</span>)</td><td class="resultValueCell resultTopCell resultBottomCell"></td><td class="resultValueCell resultTopCell resultBottomCell dataCellAdEv"> <span class="add_hilite">4</span> / <span class="add_hilite">41</span> ( <span class="add_hilite">9.76%</span>)</td><td class="resultValueCell resultTopCell resultBottomCell"></td><td class="resultValueCell resultTopCell resultBottomCell dataCellAdEv"> <span class="add_hilite">8</span> / <span class="add_hilite">41</span> ( <span class="add_hilite">19.51%</span>)</td><td class="resultValueCell resultTopCell resultBottomCell"></td></tr>
|
|
<tr><td class="resultLabelCell labelCellAdEv resultTopCell" colspan="7"> <span class="add_hilite">Injury, poisoning and procedural complications</span></td></tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="resultLabelCellRight labelCellAdEv" style="min-width: 250px;"> <span class="add_hilite">Fall <sup class="commentAdEvIndex">† A </sup></span></td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">3</span> / <span class="add_hilite">39</span> ( <span class="add_hilite">7.69%</span>)</td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">5</span></td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">2</span> / <span class="add_hilite">41</span> ( <span class="add_hilite">4.88%</span>)</td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">3</span></td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">3</span> / <span class="add_hilite">41</span> ( <span class="add_hilite">7.32%</span>)</td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">3</span></td></tr>
|
|
<tr><td class="resultLabelCell labelCellAdEv resultTopCell" colspan="7"> <span class="add_hilite">Nervous system disorders</span></td></tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="resultLabelCellRight labelCellAdEv" style="min-width: 250px;"> <span class="add_hilite">Dizziness <sup class="commentAdEvIndex">† A </sup></span></td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">2</span> / <span class="add_hilite">39</span> ( <span class="add_hilite">5.13%</span>)</td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">2</span></td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span> / <span class="add_hilite">41</span> ( <span class="add_hilite">0%</span>)</td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span></td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">1</span> / <span class="add_hilite">41</span> ( <span class="add_hilite">2.44%</span>)</td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">1</span></td></tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="resultLabelCellRight labelCellAdEv" style="min-width: 250px;"> <span class="add_hilite">Somnolence <sup class="commentAdEvIndex">† A </sup></span></td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">2</span> / <span class="add_hilite">39</span> ( <span class="add_hilite">5.13%</span>)</td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">2</span></td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">1</span> / <span class="add_hilite">41</span> ( <span class="add_hilite">2.44%</span>)</td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">1</span></td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">1</span> / <span class="add_hilite">41</span> ( <span class="add_hilite">2.44%</span>)</td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">1</span></td></tr>
|
|
<tr><td class="resultLabelCell labelCellAdEv resultTopCell" colspan="7"> <span class="add_hilite">Psychiatric disorders</span></td></tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="resultLabelCellRight labelCellAdEv" style="min-width: 250px;"> <span class="add_hilite">Hallucination <sup class="commentAdEvIndex">† A </sup></span></td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">2</span> / <span class="add_hilite">39</span> ( <span class="add_hilite">5.13%</span>)</td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">2</span></td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span> / <span class="add_hilite">41</span> ( <span class="add_hilite">0%</span>)</td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span></td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">2</span> / <span class="add_hilite">41</span> ( <span class="add_hilite">4.88%</span>)</td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">2</span></td></tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="resultLabelCellRight labelCellAdEv" style="min-width: 250px;"> <span class="add_hilite">Insomnia <sup class="commentAdEvIndex">† A </sup></span></td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">1</span> / <span class="add_hilite">39</span> ( <span class="add_hilite">2.56%</span>)</td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">1</span></td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span> / <span class="add_hilite">41</span> ( <span class="add_hilite">0%</span>)</td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span></td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">3</span> / <span class="add_hilite">41</span> ( <span class="add_hilite">7.32%</span>)</td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">3</span></td></tr>
|
|
<tr><td class="resultLabelCell labelCellAdEv resultTopCell" colspan="7"> <span class="add_hilite">Vascular disorders</span></td></tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="resultLabelCellRight labelCellAdEv" style="min-width: 250px;"> <span class="add_hilite">Orthostatic hypotension <sup class="commentAdEvIndex">† A </sup></span></td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">3</span> / <span class="add_hilite">39</span> ( <span class="add_hilite">7.69%</span>)</td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">3</span></td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">2</span> / <span class="add_hilite">41</span> ( <span class="add_hilite">4.88%</span>)</td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">2</span></td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span> / <span class="add_hilite">41</span> ( <span class="add_hilite">0%</span>)</td><td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span></td></tr>
|
|
<tr><td colspan="7"><span class="commentAdEvIndex" style="font-weight:bold;margin-right:1em;">†</span> <span class="add_hilite">Indicates events were collected by systematic assessment.</span><br>
|
|
<span class="add_hilite"><span class="commentAdEvIndex" style="margin-right:1em;">A</span>Term from vocabulary, MedDRA (11.1)</span><br>
|
|
</td></tr>
|
|
</table></tr> </tbody>
|
|
</table>
|
|
</div>
|
|
</fieldset>
|
|
</div>
|
|
</form>
|
|
</td></tr>
|
|
<tr><td colspan="3"><a id="LimitationsandCaveatsorMoreInformation"></a></td></tr><tr>
|
|
<td colspan=3>
|
|
<form id="form_LimitationsandCaveats"><a id="LimitationsandCaveats"></a><div><fieldset class="entryReq" style="margin:auto;margin-bottom:1em;width:98%;padding-bottom:0.5em;">
|
|
<legend class="moduleLabel"> <img id="LimitationsandCaveatsImg" class="toggleImage" onclick="toggleModule('LimitationsandCaveats');" src="html/images/collapse.png" alt='Open or close this module'>
|
|
Limitations and Caveats</legend>
|
|
<div id="LimitationsandCaveatsBody" class="moduleBody">
|
|
<table class="indent1 moduleTable resultTable"> <thead>
|
|
<tr style="line-height: 0;">
|
|
<th style="width:10%;"></th>
|
|
<th style="width:90%;"></th>
|
|
</tr>
|
|
</thead>
|
|
<tbody>
|
|
<tr><td colspan="2"><div class="indent1">[Not specified]</div></td></tr>
|
|
</tbody>
|
|
</table>
|
|
</div>
|
|
</fieldset>
|
|
</div>
|
|
</form>
|
|
</td></tr>
|
|
<tr>
|
|
<td colspan=3>
|
|
<form id="form_MoreInformation"><a id="MoreInformation"></a><div><fieldset class="entryReq" style="margin:auto;margin-bottom:1em;width:98%;padding-bottom:0.5em;">
|
|
<legend class="moduleLabel"> <img id="MoreInformationImg" class="toggleImage" onclick="toggleModule('MoreInformation');" src="html/images/collapse.png" alt='Open or close this module'>
|
|
More Information</legend>
|
|
<div id="MoreInformationBody" class="moduleBody">
|
|
<table class="indent1 moduleTable resultTable"><thead>
|
|
<tr style="line-height: 0;">
|
|
<th style="width:20%;"></th>
|
|
<th style="width:80%;"></th>
|
|
</tr>
|
|
</thead>
|
|
<tbody>
|
|
<tr><td colspan="2"><span style="font-weight:bold;">Certain Agreements</span>:</td></tr>
|
|
<tr><td colspan="2"><div class="indent1" style="display:inline-block;"> <span class="add_hilite">Principal Investigators are NOT employed by the organization sponsoring the study.<br/><br/>There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. <br/><br/><span class="indent1" style="display:inline-block;background-color:inherit">Investigator may publish the study results, relative to his/her own patients, only after review, comment and approval by the sponsor. No publication of confidential information shall be made without the sponsor's prior written consent. At least 60 days prior to submitting a manuscript or prior to any public presentation, a copy of the manuscript or presentation will be provided to the sponsor for review and comment. The sponsor has 60 days to review and comment.</span></span></div></td></tr>
|
|
<tr><td colspan="2"><div style="margin-top:1em;"><span style="font-weight:bold;">Results Point of Contact</span>:</div></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"><div class="indent1" style="text-align:left;">Name/Official Title:</div></td>
|
|
<td> <span class="add_hilite">Roger Mills, MD</span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"><div class="indent1" style="text-align:left;">Organization:</div></td>
|
|
<td> <span class="add_hilite">ACADIA Pharmaceuticals Inc.</span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"><div class="indent1" style="text-align:left;">Phone:</div></td>
|
|
<td> <span class="add_hilite">858-202-7563</span></td></tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"><div class="indent1" style="text-align:left;">Email:</div></td>
|
|
<td> <span class="add_hilite">rmills@acadia-pharm.com</span></td></tr>
|
|
</tbody>
|
|
</table>
|
|
</div>
|
|
</fieldset>
|
|
</div>
|
|
</form>
|
|
</td></tr>
|
|
</tbody></table>
|
|
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