Viewing Study NCT00563368

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Ignite Creation Date: 2025-12-24 @ 6:27 PM
Ignite Modification Date: 2025-12-28 @ 3:59 PM
Study NCT ID: NCT00563368
Status: COMPLETED
Last Update Posted: 2015-03-30
First Post: 2007-11-21
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: A Study Comparing Multiple Doses of VI-0521 With Placebo and Their Single-agent Constituents for Treatment of Obesity in Adults
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077236', 'term': 'Topiramate'}, {'id': 'D010645', 'term': 'Phentermine'}], 'ancestors': [{'id': 'D005632', 'term': 'Fructose'}, {'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D007661', 'term': 'Ketoses'}, {'id': 'D000662', 'term': 'Amphetamines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'day@vivus.com', 'phone': '650-934-5200', 'title': 'Wesley W. Day PhD', 'organization': 'Vivus, Inc.'}, 'certainAgreement': {'otherDetails': "After Sponsor's written notification that publication of results is no longer planned or 12 months after termination of the study at all sites, Institution \\& PI may publish, upon written approval from Sponsor, results of the Study. Sponsor will be given the opportunity to review any proposed publication at least 60 days prior to submission for publication or disclosure. Upon Sponsor's written request, Institution and PI shall not publish or disclose information related to the Study.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.', 'description': 'Only subjects who received at least one dose of study drug were included in the safety analysis.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo', 'otherNumAtRisk': 109, 'otherNumAffected': 87, 'seriousNumAtRisk': 109, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'PHEN 7.5 mg', 'description': '7.5 mg phentermine', 'otherNumAtRisk': 109, 'otherNumAffected': 85, 'seriousNumAtRisk': 109, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'TPM 46 mg', 'description': '46 mg topiramate', 'otherNumAtRisk': 106, 'otherNumAffected': 90, 'seriousNumAtRisk': 106, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'VI-0521 Mid', 'description': '7.5 mg/46 mg phentermine/topiramate', 'otherNumAtRisk': 106, 'otherNumAffected': 84, 'seriousNumAtRisk': 106, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'PHEN 15 mg', 'description': '15 mg phentermine', 'otherNumAtRisk': 108, 'otherNumAffected': 88, 'seriousNumAtRisk': 108, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'TPM 92 mg', 'description': '92 mg topiramate', 'otherNumAtRisk': 107, 'otherNumAffected': 84, 'seriousNumAtRisk': 107, 'seriousNumAffected': 1}, {'id': 'EG006', 'title': 'VI-0521 Top', 'description': '15 mg/92 mg phentermine/topiramate', 'otherNumAtRisk': 108, 'otherNumAffected': 88, 'seriousNumAtRisk': 108, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 108, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 107, 'numAffected': 14}, {'groupId': 'EG006', 'numAtRisk': 108, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 10}, {'groupId': 'EG005', 'numAtRisk': 107, 'numAffected': 9}, {'groupId': 'EG006', 'numAtRisk': 108, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 108, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 107, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 108, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 107, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 108, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 108, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 12}, {'groupId': 'EG005', 'numAtRisk': 107, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 108, 'numAffected': 11}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 107, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 108, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 107, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 108, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 108, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 16}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 11}, {'groupId': 'EG005', 'numAtRisk': 107, 'numAffected': 11}, {'groupId': 'EG006', 'numAtRisk': 108, 'numAffected': 17}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Paresthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 18}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 107, 'numAffected': 24}, {'groupId': 'EG006', 'numAtRisk': 108, 'numAffected': 25}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 108, 'numAffected': 16}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 107, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 108, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Disturbance in Attention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 107, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 108, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 13}, {'groupId': 'EG005', 'numAtRisk': 107, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 108, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 107, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 108, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 107, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 108, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 107, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 108, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}], 'seriousEvents': [{'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Jaundice cholestatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Malignant neoplasm of ampulia of vater', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Pelvic Mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'cardiac arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Weight Loss From Baseline to Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}, {'value': '103', 'groupId': 'OG003'}, {'value': '106', 'groupId': 'OG004'}, {'value': '105', 'groupId': 'OG005'}, {'value': '103', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo'}, {'id': 'OG001', 'title': 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'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat Last-observation-carried-forward (ITT-LOCF)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo'}, {'id': 'FG001', 'title': 'PHEN 7.5 mg', 'description': '7.5 mg phentermine'}, {'id': 'FG002', 'title': 'TPM 46 mg', 'description': '46 mg topiramate'}, {'id': 'FG003', 'title': 'VI-0521 Mid', 'description': '7.5 mg/46 mg phentermine/topiramate'}, {'id': 'FG004', 'title': 'PHEN 15 mg', 'description': '15 mg phentermine'}, {'id': 'FG005', 'title': 'TPM 92 mg', 'description': '92 mg topiramate'}, {'id': 'FG006', 'title': 'VI-0521 Top', 'description': '15 mg/92 mg phentermine/topiramate'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '109'}, {'groupId': 'FG001', 'numSubjects': '109'}, {'groupId': 'FG002', 'numSubjects': '108'}, {'groupId': 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{'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '8'}, {'groupId': 'FG006', 'numSubjects': '9'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '10'}, {'groupId': 'FG006', 'numSubjects': '17'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '4'}]}, {'type': 'protocol non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '3'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'requirement for restricted medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subject recruitment occurred at investigative sites in the US between November 2007 through January 2008'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}, {'value': '107', 'groupId': 'BG003'}, {'value': '108', 'groupId': 'BG004'}, {'value': '107', 'groupId': 'BG005'}, {'value': '108', 'groupId': 'BG006'}, {'value': '756', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo'}, {'id': 'BG001', 'title': 'PHEN 7.5 mg', 'description': '7.5 mg phentermine'}, {'id': 'BG002', 'title': 'TPM 46 mg', 'description': '46 mg 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'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}, {'value': '85', 'groupId': 'BG003'}, {'value': '86', 'groupId': 'BG004'}, {'value': '85', 'groupId': 'BG005'}, {'value': '85', 'groupId': 'BG006'}, {'value': '599', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}, {'value': '23', 'groupId': 'BG006'}, {'value': '157', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}, {'value': '107', 'groupId': 'BG003'}, {'value': '108', 'groupId': 'BG004'}, {'value': '107', 'groupId': 'BG005'}, {'value': '108', 'groupId': 'BG006'}, {'value': '756', 'groupId': 'BG007'}]}]}], 'paramType': 'NUMBER', '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': 756}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'dispFirstSubmitDate': '2009-11-18', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-10', 'studyFirstSubmitDate': '2007-11-21', 'dispFirstSubmitQcDate': '2009-11-18', 'resultsFirstSubmitDate': '2012-07-31', 'studyFirstSubmitQcDate': '2007-11-21', 'dispFirstPostDateStruct': {'date': '2009-11-20', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-03-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-07-31', 'studyFirstPostDateStruct': {'date': '2007-11-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-09-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Weight Loss From Baseline to Week 28', 'timeFrame': 'baseline to 28 weeks', 'description': 'Percent weight loss from baseline to Week 28 with last observation carried forward (LOCF)'}, {'measure': 'Percentage of Subjects With at Least 5% Weight Loss at Week 28 With LOCF', 'timeFrame': 'baseline to 28 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the safety and efficacy of various doses of VI-0521 compared to both placebo, and the single-agent components that comprise each combination dose. This study will provide confirmatory data to demonstrate that doses of VI-0521 have efficacy that is greater than placebo and each of the single-agent components that comprise the combination dose.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 70 years of age or less with body mass index (BMI) between 30 and 45 kg/m2\n* Informed Consent\n* Females of child-bearing potential must be using adequate contraception\n\nExclusion Criteria:\n\n* Stroke/myocardial infarction (MI)/unstable cardiovascular disease within 6 months\n* Clinically significant renal, hepatic or psychiatric disease\n* Unstable thyroid disease or replacement therapy\n* Nephrolithiasis\n* Obesity of known genetic or endocrine origin\n* Participation in a formal weight loss program or lifestyle intervention\n* Glaucoma or elevated intraocular pressure\n* Pregnancy or breastfeeding\n* Drug or Alcohol abuse\n* Smoking cessation within previous 3 months or plans to quit smoking during study\n* Eating disorders within past year\n* Cholelithiasis within past 6 months\n* Type 2 diabetes\n* Previous bariatric surgery\n* Bipolar disorder or psychosis\n* Steroid hormone therapy not stable for 3 months\n* Systolic blood pressure \\> 160 mmHg, diastolic blood pressure \\> 100 mmHg'}, 'identificationModule': {'nctId': 'NCT00563368', 'briefTitle': 'A Study Comparing Multiple Doses of VI-0521 With Placebo and Their Single-agent Constituents for Treatment of Obesity in Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'VIVUS LLC'}, 'officialTitle': 'A Phase III, Randomized, Double-Blind, Parallel-Design Study Comparing Multiple Doses of VI-0521 to Placebo and Their Single-Agent Phentermine and Topiramate Constituents for the Treatment of Obesity in Adults', 'orgStudyIdInfo': {'id': 'OB-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VI-0521 Top', 'description': 'VI-0521; high dose phentermine/topiramate', 'interventionNames': ['Drug: VI-0521']}, {'type': 'EXPERIMENTAL', 'label': 'VI-0521 Mid', 'description': 'VI-0521; mid dose phentermine/topiramate', 'interventionNames': ['Drug: VI-0521']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TPM 46', 'description': 'mid dose topiramate', 'interventionNames': ['Drug: topiramate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TPM 92', 'description': 'high dose topiramate', 'interventionNames': ['Drug: topiramate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PHEN 7.5', 'description': 'mid dose phentermine', 'interventionNames': ['Drug: phentermine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PHEN 15', 'description': 'high dose phentermine', 'interventionNames': ['Drug: phentermine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: VI-0521']}], 'interventions': [{'name': 'VI-0521', 'type': 'DRUG', 'description': 'phentermine 15 mg and topiramate 92 mg, po once daily', 'armGroupLabels': ['VI-0521 Top']}, {'name': 'VI-0521', 'type': 'DRUG', 'description': 'phentermine 7.5 mg and topiramate 46 mg, po once daily', 'armGroupLabels': ['VI-0521 Mid']}, {'name': 'topiramate', 'type': 'DRUG', 'description': 'topiramate 46 mg, po once daily', 'armGroupLabels': ['TPM 46']}, {'name': 'topiramate', 'type': 'DRUG', 'description': 'topiramate 92 mg, po once daily', 'armGroupLabels': ['TPM 92']}, {'name': 'phentermine', 'type': 'DRUG', 'description': 'phentermine 7.5 mg, po once daily', 'armGroupLabels': ['PHEN 7.5']}, {'name': 'phentermine', 'type': 'DRUG', 'description': 'phentermine 15 mg, po once daily', 'armGroupLabels': ['PHEN 15']}, {'name': 'VI-0521', 'type': 'DRUG', 'description': 'placebo, po once daily', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Craig Peterson', 'role': 'STUDY_DIRECTOR', 'affiliation': 'VIVUS LLC'}, {'name': 'Kishore Gadde, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Duke University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VIVUS LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Medpace, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}