Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT00281320
Status:
COMPLETED
Last Update Posted:
2022-02-09
First Post:
2006-01-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of Asenapine in Elderly Subjects With Psychosis (A7501021)(P05717)
Sponsor:
Organization:
Raw JSON
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If any patent action is required to protect intellectual property rights, Institution agrees to delay the disclosure for a period not to exceed and additional 60 days. 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'EG000', 'numAtRisk': 61, 'numEvents': 11, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '10.1'}], 'seriousEvents': [{'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '10.1'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '10.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 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'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All-Subjects-Pharmacokinetically-Evaluable Group defined as all subjects for which at least one pharmacokinetic parameter could be calculated and who did not have any protocol violations interfering with pharmacokinetics.'}, {'type': 'PRIMARY', 'title': 'Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis,Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Asenapine 5mg BID Day 4', 'description': 'Pharmacokinetic parameter of asepanine for Day 4.'}, {'id': 'OG001', 'title': 'Asenapine 10mg BID Day 8', 'description': 'Pharmacokinetic parameter of asepanine for Day 8.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.01', 'spread': '3.89', 'groupId': 'OG000'}, {'value': '10.3', 'spread': '6.71', 'groupId': 'OG001'}]}]}], 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'groups': [{'id': 'OG000', 'title': 'Asenapine 5mg BID Day 4', 'description': 'Pharmacokinetic parameter of asenapine for Day 4.'}, {'id': 'OG001', 'title': 'Asenapine 10mg BID Day 8', 'description': 'Pharmacokinetic parameter of asenapine for Day 8.'}], 'classes': [{'categories': [{'measurements': [{'value': '38.6', 'spread': '21.1', 'groupId': 'OG000'}, {'value': '70.3', 'spread': '41.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 4 or 8', 'description': 'AUC 0-12 defined as area-under-the-curve from zero to time point 12 hours.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All-Subjects-Pharmacokinetically-Evaluable Group defined as all subjects for which at least one pharmacokinetic parameter could be calculated and who did not have any protocol violations interfering with pharmacokinetics.'}, {'type': 'PRIMARY', 'title': 'Pharmacokinetics of Asenapine up to Doses of 10 mg BID in 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could be calculated and who did not have any protocol violations interfering with pharmacokinetics.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Asenapine 2-10 mg Twice Daily (BID)', 'description': 'Asenapine 2 mg twice daily (BID) on Days 1 and 2, 5 mg BID on Days 3 and 4, followed by 10 mg BID on Day 5 through the end of the trial (Week 6)'}, {'id': 'FG001', 'title': 'Asenapine 5-10 mg BID', 'description': 'Asenapine 5 mg BID on Days 1 to 4 followed by 10 mg BID on Day 5 through the end of the trial (Week 6)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '61'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '21'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Asenapine 2-10 mg BID', 'description': 'Asenapine 2 mg twice daily (BID) on Days 1 and 2, 5 mg BID on Days 3 and 4, followed by 10 mg BID on Day 5 through the end of the trial (Week 6)'}, {'id': 'BG001', 'title': 'Asenapine 5-10 mg BID', 'description': 'Asenapine 5 mg twice daily (BID) on Days 1 to 4 followed by 10 mg BID on Day 5 through the end of the trial (Week 6)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70.5', 'spread': '4.6', 'groupId': 'BG000'}, {'value': '72.0', 'spread': '5.8', 'groupId': 'BG001'}, {'value': '71.2', 'spread': '5.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 122}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'dispFirstSubmitDate': '2009-04-17', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-07', 'studyFirstSubmitDate': '2006-01-23', 'dispFirstSubmitQcDate': '2009-10-02', 'resultsFirstSubmitDate': '2010-08-12', 'studyFirstSubmitQcDate': '2006-01-23', 'dispFirstPostDateStruct': {'date': '2009-10-06', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2022-02-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-08-12', 'studyFirstPostDateStruct': {'date': '2006-01-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Experienced an Adverse Event', 'timeFrame': 'Up to Day 42 (treatment period)', 'description': 'Participants who experienced treatment-emergent adverse events, defined as newly reported events after baseline or events reported to have worsened in severity since baseline (from the date of informed consent to the last dose day + 7 days for non-serious adverse events and 30 days for serious adverse events).'}, {'measure': 'Number of Participants Who Discontinued Because of an Adverse Event', 'timeFrame': 'up to 30 days after study medication stop date', 'description': 'Discontinuations due to treatment-emergent adverse events starting on or after Day1 and up to 7 days after study medication stop date (30 days for serious adverse events).'}, {'measure': 'Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Tmax', 'timeFrame': 'Day 4 or 8', 'description': 'Tmax defined as time to peak concentration.'}, {'measure': 'Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis,Cmax', 'timeFrame': 'Day 4 or 8', 'description': 'Cmax defined as peak concentration.'}, {'measure': 'Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis , Dn-Cmax', 'timeFrame': 'Day 4 or 8', 'description': 'dn-Cmax is defined as dose normalized peak concentration.'}, {'measure': 'Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Cmin', 'timeFrame': 'Day 4 or 8', 'description': 'Cmin defined as pre-dose concentration.'}, {'measure': 'Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, AUC 0-12', 'timeFrame': 'Day 4 or 8', 'description': 'AUC 0-12 defined as area-under-the-curve from zero to time point 12 hours.'}, {'measure': 'Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Dn-AUC 0-12', 'timeFrame': 'Day 4 or 8', 'description': 'dn-AUC 0-12 defined as dose-normalized area-under-the-curve from zero to time point 12 hours.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Psychosis']}, 'referencesModule': {'references': [{'pmid': '21755540', 'type': 'RESULT', 'citation': 'Dubovsky SL, Frobose C, Phiri P, de Greef R, Panagides J. Short-term safety and pharmacokinetic profile of asenapine in older patients with psychosis. Int J Geriatr Psychiatry. 2012 May;27(5):472-82. doi: 10.1002/gps.2737. Epub 2011 Jul 13.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the safety and tolerability of Asenapine in elderly patients with psychosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elderly subjects with psychosis\n\nExclusion Criteria:\n\n* Have an uncontrolled, unstable clinically significant\n\nmedical condition.\n\n* Have an established diagnosis of dementia'}, 'identificationModule': {'nctId': 'NCT00281320', 'briefTitle': 'Study of Asenapine in Elderly Subjects With Psychosis (A7501021)(P05717)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'A Randomized, Parallel Group, Multiple Dose, 6-Week Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Asenapine in Elderly Subjects With Psychosis.', 'orgStudyIdInfo': {'id': 'P05717'}, 'secondaryIdInfos': [{'id': 'A7501021'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Asenapine 2-10 mg BID', 'description': 'Dose titration from 2 mg to 5 mg to 10 mg twice daily (BID)', 'interventionNames': ['Drug: Asenapine']}, {'type': 'EXPERIMENTAL', 'label': 'Asenapine 5-10mg BID', 'description': 'Dose titration from 5 mg to 10 mg BID', 'interventionNames': ['Drug: Asenapine']}], 'interventions': [{'name': 'Asenapine', 'type': 'DRUG', 'otherNames': ['Saphris'], 'description': 'Asenapine 2 mg twice daily (BID) on Days 1 and 2, 5 mg BID on Days 3 and 4, followed by 10 mg BID on Day 5 through the end of the trial (Week 6); or Asenapine 5 mg BID on Days 1 to 4 followed by 10 mg BID on Day 5 through the end of the trial (Week 6).', 'armGroupLabels': ['Asenapine 2-10 mg BID', 'Asenapine 5-10mg BID']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Organon and Co', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}