Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT05215418
Status:
COMPLETED
Last Update Posted:
2024-07-17
First Post:
2022-01-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of VI-0521 on Ambulatory Blood Pressure (ABPM) in Overweight or Obese Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'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': 'C576188', 'term': 'Qsymia'}, {'id': 'D010645', 'term': 'Phentermine'}], 'ancestors': [{'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': 'clinical@vivus.com', 'phone': '650-934-5246', 'title': 'Lan Nguyen', 'organization': 'Vivus LLC'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': "Participants with baseline blood pressure greater than 140/90 were excluded. Of the 565 total participants randomized and treated with study drug, 180 participants were excluded from the per protocol population used for the primary analysis due to participants' reluctance or inability to properly complete end of study ABPM assessments."}}, 'adverseEventsModule': {'timeFrame': 'Up to a total of 12 weeks (from baseline to 28 days after last dose of study drug)', 'eventGroups': [{'id': 'EG000', 'title': 'VI-0521 Top Dose (Phentermine 15 mg + Topiramate 92 mg)', 'description': 'Week 1: VI-0521 (Phentermine 3.75 mg + Topiramate 23 mg) oral capsule, once daily; Week 2: VI-0521 (Phentermine 7.5 mg + Topiramate 46 mg) oral capsule, once daily; Week 3: VI-0521 (Phentermine 11.25 mg + Topiramate 69 mg) oral capsule, once daily; Weeks 4-8: VI-0521 (Phentermine 15 mg + Topiramate 92 mg) oral capsule, once daily\n\nVI-0521: Phentermine/Topiramate Top Dose 15 mg/92 mg capsule', 'otherNumAtRisk': 190, 'deathsNumAtRisk': 190, 'otherNumAffected': 66, 'seriousNumAtRisk': 190, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Phentermine 30mg', 'description': 'Weeks 1-8: Phentermine 30mg oral capsule, once daily\n\nPhentermine: Phentermine 30 mg capsule', 'otherNumAtRisk': 191, 'deathsNumAtRisk': 191, 'otherNumAffected': 44, 'seriousNumAtRisk': 191, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Weeks 1-8: Placebo oral capsule, once daily\n\nPlacebo: Inactive oral capsule', 'otherNumAtRisk': 184, 'deathsNumAtRisk': 184, 'otherNumAffected': 6, 'seriousNumAtRisk': 184, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 184, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numEvents': 27, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}], 'seriousEvents': [{'term': 'Angina pectoris', 'notes': 'chest pain or discomfort due to coronary heart disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 184, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to Week 8 in Mean Systolic Blood Pressure as Measured by 24-hr ABPM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VI-0521 Top Dose (Phentermine 15 mg + Topiramate 92 mg)', 'description': 'Week 1: VI-0521 (Phentermine 3.75 mg + Topiramate 23 mg) oral capsule, once daily; Week 2: VI-0521 (Phentermine 7.5 mg + Topiramate 46 mg) oral capsule, once daily; Week 3: VI-0521 (Phentermine 11.25 mg + Topiramate 69 mg) oral capsule, once daily; Weeks 4-8: VI-0521 (Phentermine 15 mg + Topiramate 92 mg) oral capsule, once daily\n\nVI-0521: Phentermine/Topiramate Top Dose 15 mg/92 mg capsule'}, {'id': 'OG001', 'title': 'Phentermine 30mg', 'description': 'Weeks 1-8: Phentermine 30mg oral capsule, once daily\n\nPhentermine: Phentermine 30 mg capsule'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Weeks 1-8: Placebo oral capsule, once daily\n\nPlacebo: Inactive oral capsule'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.3', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.05', 'groupId': 'OG001'}, {'value': '-0.1', 'spread': '1.04', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean SBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.'}, {'pValue': '0.0059', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean SBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.'}, {'pValue': '0.1867', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean SBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 8', 'description': 'The change between systolic blood pressure measured at Week 8 relative to the baseline measurements from the ABPM data read out. Blood pressure and heart rate were measured every 20 minutes from 6:00 to 22:00 hours, and every 30 minutes from 22:01 to 5:59 hours for 24 consecutive hours, while subjects continue normal routine activities.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who completed the study per protocol. Per Protocol Population (PPP) was defined as:\n\n1. Randomized and received at least one dose of study drug;\n2. ≥ 80% treatment compliance;\n3. Last daily dose of study drug administered on the same date that ABPM was initiated at Week 8/End of Study or early termination (EOS);\n4. ≥ 23.5 hours of ABPM data at baseline and at Week 8/EOS or early termination, and ≥ 75% ABPM readings;\n5. No major protocol deviation that impacted ABPM readings.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 8 in Mean Diastolic Blood Pressure as Measured by 24-hr ABPM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VI-0521 Top Dose (Phentermine 15 mg + Topiramate 92 mg)', 'description': 'Week 1: VI-0521 (Phentermine 3.75 mg + Topiramate 23 mg) oral capsule, once daily; Week 2: VI-0521 (Phentermine 7.5 mg + Topiramate 46 mg) oral capsule, once daily; Week 3: VI-0521 (Phentermine 11.25 mg + Topiramate 69 mg) oral capsule, once daily; Weeks 4-8: VI-0521 (Phentermine 15 mg + Topiramate 92 mg) oral capsule, once daily\n\nVI-0521: Phentermine/Topiramate Top Dose 15 mg/92 mg capsule'}, {'id': 'OG001', 'title': 'Phentermine 30mg', 'description': 'Weeks 1-8: Phentermine 30mg oral capsule, once daily\n\nPhentermine: Phentermine 30 mg capsule'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Weeks 1-8: Placebo oral capsule, once daily\n\nPlacebo: Inactive oral capsule'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '0.64', 'groupId': 'OG001'}, {'value': '-0.4', 'spread': '0.63', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0277', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean DBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.'}, {'pValue': '0.0852', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean DBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.'}, {'pValue': '<.0001', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean DBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 8', 'description': 'The change between diastolic blood pressure measured at Week 8 relative to the baseline measurements from the ABPM data read out. Blood pressure and heart rate were measured every 20 minutes from 6:00 to 22:00 hours, and every 30 minutes from 22:01 to 5:59 hours for 24 consecutive hours, while subjects continue normal routine activities.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who completed the study per protocol. Per Protocol Population (PPP) was defined as:\n\n1. Randomized and received at least one dose of study drug;\n2. ≥ 80% treatment compliance;\n3. Last daily dose of study drug administered on the same date that ABPM was initiated at Week 8/End of Study or early termination (EOS);\n4. ≥ 23.5 hours of ABPM data at baseline and at Week 8/EOS or early termination, and ≥ 75% ABPM readings;\n5. No major protocol deviation that impacted ABPM readings.'}, {'type': 'SECONDARY', 'title': 'Mean Change in Systolic and Diastolic Blood Pressure From Baseline to Week 8 as Measured in Clinic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VI-0521 Top Dose (Phentermine 15 mg + Topiramate 92 mg)', 'description': 'Week 1: VI-0521 (Phentermine 3.75 mg + Topiramate 23 mg) oral capsule, once daily; Week 2: VI-0521 (Phentermine 7.5 mg + Topiramate 46 mg) oral capsule, once daily; Week 3: VI-0521 (Phentermine 11.25 mg + Topiramate 69 mg) oral capsule, once daily; Weeks 4-8: VI-0521 (Phentermine 15 mg + Topiramate 92 mg) oral capsule, once daily\n\nVI-0521: Phentermine/Topiramate Top Dose 15 mg/92 mg capsule'}, {'id': 'OG001', 'title': 'Phentermine 30mg', 'description': 'Weeks 1-8: Phentermine 30mg oral capsule, once daily\n\nPhentermine: Phentermine 30 mg capsule'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Weeks 1-8: Placebo oral capsule, once daily\n\nPlacebo: Inactive oral capsule'}], 'classes': [{'title': 'Systolic blood pressure as measured in clinic', 'categories': [{'measurements': [{'value': '-4.3', 'spread': '1.15', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '1.13', 'groupId': 'OG001'}, {'value': '-1.7', 'spread': '1.12', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic blood pressure as measured in clinic', 'categories': [{'measurements': [{'value': '-1.3', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.81', 'groupId': 'OG001'}, {'value': '-1.1', 'spread': '0.80', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0109', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'In-clinic systolic blood pressure', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean SBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.'}, {'pValue': '0.0339', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'In-clinic systolic blood pressure', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean SBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.'}, {'pValue': '0.6769', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'In-clinic systolic blood pressure', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean SBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.'}, {'pValue': '0.0082', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'In-clinic diastolic blood pressure', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean DBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.'}, {'pValue': '0.8131', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'In-clinic diastolic blood pressure', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean DBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.'}, {'pValue': '0.0150', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'In-clinic diastolic blood pressure', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean DBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 8', 'description': "The change between systolic and diastolic blood pressure measured in the clinic at Week 8 relative to the baseline measurements after subjects are seated comfortably for at least 10 minutes prior to taking blood pressure. In clinic blood pressure for determining hypertension was the average of three successive blood pressure readings, collected at least 2 minutes apart. The mean of the three values was be recorded as the subject's blood pressure.", 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who completed the study per protocol. Per Protocol Population (PPP) was defined as:\n\n1. Randomized and received at least one dose of study drug;\n2. ≥ 80% treatment compliance;\n3. Last daily dose of study drug administered on the same date that ABPM was initiated at Week 8/End of Study or early termination (EOS);\n4. ≥ 23.5 hours of ABPM data at baseline and at Week 8/EOS or early termination, and ≥ 75% ABPM readings;\n5. No major protocol deviation that impacted ABPM readings.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'VI-0521 Top Dose (Phentermine 15 mg + Topiramate 92 mg)', 'description': 'Week 1: VI-0521 (Phentermine 3.75 mg + Topiramate 23 mg) oral capsule, once daily; Week 2: VI-0521 (Phentermine 7.5 mg + Topiramate 46 mg) oral capsule, once daily; Week 3: VI-0521 (Phentermine 11.25 mg + Topiramate 69 mg) oral capsule, once daily; Weeks 4-8: VI-0521 (Phentermine 15 mg + Topiramate 92 mg) oral capsule, once daily\n\nVI-0521: Phentermine/Topiramate Top Dose 15 mg/92 mg capsule'}, {'id': 'FG001', 'title': 'Phentermine 30mg', 'description': 'Weeks 1-8: Phentermine 30mg oral capsule, once daily\n\nPhentermine: Phentermine 30 mg capsule'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Weeks 1-8: Placebo oral capsule, once daily\n\nPlacebo: Inactive oral capsule'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '190'}, {'groupId': 'FG001', 'numSubjects': '191'}, {'groupId': 'FG002', 'numSubjects': '184'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '156'}, {'groupId': 'FG001', 'numSubjects': '167'}, {'groupId': 'FG002', 'numSubjects': '164'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '20'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'BG000'}, {'value': '191', 'groupId': 'BG001'}, {'value': '184', 'groupId': 'BG002'}, {'value': '565', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'VI-0521 Top Dose (Phentermine 15 mg + Topiramate 92 mg)', 'description': 'Week 1: VI-0521 (Phentermine 3.75 mg + Topiramate 23 mg) oral capsule, once daily; Week 2: VI-0521 (Phentermine 7.5 mg + Topiramate 46 mg) oral capsule, once daily; Week 3: VI-0521 (Phentermine 11.25 mg + Topiramate 69 mg) oral capsule, once daily; Weeks 4-8: VI-0521 (Phentermine 15 mg + Topiramate 92 mg) oral capsule, once daily\n\nVI-0521: Phentermine/Topiramate Top Dose 15 mg/92 mg capsule'}, {'id': 'BG001', 'title': 'Phentermine 30mg', 'description': 'Weeks 1-8: Phentermine 30mg oral capsule, once daily\n\nPhentermine: Phentermine 30 mg capsule'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Weeks 1-8: Placebo oral capsule, once daily\n\nPlacebo: Inactive oral capsule'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.6', 'spread': '13.34', 'groupId': 'BG000'}, {'value': '53.3', 'spread': '12.12', 'groupId': 'BG001'}, {'value': '53.3', 'spread': '11.36', 'groupId': 'BG002'}, {'value': '53.4', 'spread': '12.29', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '136', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}, {'value': '415', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '149', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '138', 'groupId': 'BG000'}, {'value': '141', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}, {'value': '416', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '81', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '154', 'groupId': 'BG000'}, {'value': '167', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}, {'value': '461', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '190', 'groupId': 'BG000'}, {'value': '191', 'groupId': 'BG001'}, {'value': '184', 'groupId': 'BG002'}, {'value': '565', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Hypertensive status', 'classes': [{'title': 'No Medical Diagnosis of or Treatment for Hypertension', 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '183', 'groupId': 'BG003'}]}]}, {'title': 'Medical Diagnosis of Hypertension Treated with 0 to 2 Antihypertensive Agents', 'categories': [{'measurements': [{'value': '116', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}, {'value': '353', 'groupId': 'BG003'}]}]}, {'title': 'Medical Diagnosis of Hypertension Treated with 3 or More Antihypertensive Agents', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diabetes Status', 'classes': [{'title': 'Type 2 Diabetes', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '64', 'groupId': 'BG003'}]}]}, {'title': 'Prediabetes', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}]}]}, {'title': 'Gestational Diabetes', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Borderline Diabetes', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Not Diabetic', 'categories': [{'measurements': [{'value': '137', 'groupId': 'BG000'}, {'value': '148', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}, {'value': '423', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Blood Pressure', 'classes': [{'title': 'Systolic Blood Pressure', 'categories': [{'measurements': [{'value': '123.9', 'spread': '9.82', 'groupId': 'BG000'}, {'value': '123.4', 'spread': '10.38', 'groupId': 'BG001'}, {'value': '124.5', 'spread': '11.23', 'groupId': 'BG002'}, {'value': '123.9', 'spread': '10.48', 'groupId': 'BG003'}]}]}, {'title': 'Diastolic Blood Pressure', 'categories': [{'measurements': [{'value': '77.5', 'spread': '7.63', 'groupId': 'BG000'}, {'value': '77.0', 'spread': '7.98', 'groupId': 'BG001'}, {'value': '78.3', 'spread': '7.71', 'groupId': 'BG002'}, {'value': '77.6', 'spread': '7.78', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '98.8', 'spread': '20.84', 'groupId': 'BG000'}, {'value': '99.5', 'spread': '21.58', 'groupId': 'BG001'}, {'value': '100.4', 'spread': '21.52', 'groupId': 'BG002'}, {'value': '99.6', 'spread': '21.29', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '165.7', 'spread': '9.16', 'groupId': 'BG000'}, {'value': '166.6', 'spread': '9.51', 'groupId': 'BG001'}, {'value': '166.1', 'spread': '10.08', 'groupId': 'BG002'}, {'value': '166.2', 'spread': '9.58', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI (Body Mass Index)', 'classes': [{'categories': [{'measurements': [{'value': '35.7', 'spread': '6.20', 'groupId': 'BG000'}, {'value': '35.4', 'spread': '5.88', 'groupId': 'BG001'}, {'value': '36.2', 'spread': '6.17', 'groupId': 'BG002'}, {'value': '35.8', 'spread': '6.08', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-10-15', 'size': 1583304, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-04-30T19:58', 'hasProtocol': True}, {'date': '2023-04-27', 'size': 534876, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-04-30T19:59', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 565}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'dispFirstSubmitDate': '2024-04-09', 'completionDateStruct': {'date': '2023-04-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-21', 'studyFirstSubmitDate': '2022-01-17', 'resultsFirstSubmitDate': '2024-04-30', 'studyFirstSubmitQcDate': '2022-01-17', 'dispFirstPostDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-07-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-23', 'studyFirstPostDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to Week 8 in Mean Systolic Blood Pressure as Measured by 24-hr ABPM', 'timeFrame': 'Baseline to Week 8', 'description': 'The change between systolic blood pressure measured at Week 8 relative to the baseline measurements from the ABPM data read out. Blood pressure and heart rate were measured every 20 minutes from 6:00 to 22:00 hours, and every 30 minutes from 22:01 to 5:59 hours for 24 consecutive hours, while subjects continue normal routine activities.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to Week 8 in Mean Diastolic Blood Pressure as Measured by 24-hr ABPM', 'timeFrame': 'Baseline to Week 8', 'description': 'The change between diastolic blood pressure measured at Week 8 relative to the baseline measurements from the ABPM data read out. Blood pressure and heart rate were measured every 20 minutes from 6:00 to 22:00 hours, and every 30 minutes from 22:01 to 5:59 hours for 24 consecutive hours, while subjects continue normal routine activities.'}, {'measure': 'Mean Change in Systolic and Diastolic Blood Pressure From Baseline to Week 8 as Measured in Clinic', 'timeFrame': 'Baseline to Week 8', 'description': "The change between systolic and diastolic blood pressure measured in the clinic at Week 8 relative to the baseline measurements after subjects are seated comfortably for at least 10 minutes prior to taking blood pressure. In clinic blood pressure for determining hypertension was the average of three successive blood pressure readings, collected at least 2 minutes apart. The mean of the three values was be recorded as the subject's blood pressure."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obesity', 'Overweight', 'Qsymia', 'ABPM'], 'conditions': ['Blood Pressure']}, 'referencesModule': {'references': [{'pmid': '38304225', 'type': 'DERIVED', 'citation': 'Bays HE, Hsia DS, Nguyen LT, Peterson CA, Varghese ST. Effects of phentermine / topiramate extended-release, phentermine, and placebo on ambulatory blood pressure monitoring in adults with overweight or obesity: A randomized, multicenter, double-blind study. Obes Pillars. 2024 Jan 8;9:100099. doi: 10.1016/j.obpill.2024.100099. eCollection 2024 Mar.'}]}, 'descriptionModule': {'briefSummary': 'The study is being conducted to evaluate the effect of VI-0521 (Qsymia®) on blood pressure as measured by 24-hour ambulatory blood pressure monitoring, compared to both placebo and an active control (phentermine 30 mg).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Overweight/obese adult males/females 18-75 years of age with a BMI ≥ 27 kg/m2;\n* At least 1 weight-related comorbidity (i.e., hypertension, dyslipidemia, Type 2 diabetes mellitus \\[T2DM\\] or prediabetes, or obstructive sleep apnea).\n* Must be ambulatory, willing, and able to wear ABPM monitor apparatus for 24 hours at beginning and end of study.\n\nExclusion Criteria:\n\n* Screening blood pressure of \\> 140/90 mmHg;\n* Type 1 diabetes; T2DM treated with SFUs, GLP-1 receptor agonists, SGLT inhibitors; or not on stable diabetic medications for at least 3 months prior to randomization;\n* Clinically significant cardiac, hepatic, renal, pulmonary, or thyroid disease;\n* History of bipolar disorder, psychosis, greater than one lifetime episode of major depressive disorder, or presence or history of suicidal behavior or suicidal ideation with intent to act;\n* History of glaucoma;\n* Night shift workers;\n* Obesity of known genetic or endocrine origin; recent history of weight instability, or recent participation in a formal weight loss program within 3 months prior to screening; and\n* Smoking cessation within 3 months prior to screening;\n* Use of antihypertensive medications, antidiabetic medications, statins or other lipid lowering agents, or CPAP therapy that has not been stable for at least 3 months prior to randomization;\n* COVID-19 vaccination or treatment for severe COVID-19 infection within a month prior to randomization.'}, 'identificationModule': {'nctId': 'NCT05215418', 'briefTitle': 'A Study of VI-0521 on Ambulatory Blood Pressure (ABPM) in Overweight or Obese Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'VIVUS LLC'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind Study to Compare the Effects of VI-0521,Phentermine, and Placebo on Ambulatory Blood Pressure in Overweight or Obese Subjects', 'orgStudyIdInfo': {'id': 'OB-409'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VI-0521 Top Dose (Phentermine 15 mg + Topiramate 92 mg)', 'description': 'Week 1: VI-0521 (Phentermine 3.75 mg + Topiramate 23 mg) oral capsule, once daily; Week 2: VI-0521 (Phentermine 7.5 mg + Topiramate 46 mg) oral capsule, once daily; Week 3: VI-0521 (Phentermine 11.25 mg + Topiramate 69 mg) oral capsule, once daily; Weeks 4-8: VI-0521 (Phentermine 15 mg + Topiramate 92 mg) oral capsule, once daily', 'interventionNames': ['Drug: VI-0521']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Phentermine 30mg', 'description': 'Weeks 1-8: Phentermine 30mg oral capsule, once daily', 'interventionNames': ['Drug: Phentermine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Weeks 1-8: Placebo oral capsule, once daily', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'VI-0521', 'type': 'DRUG', 'otherNames': ['Qsymia', 'Phentermine and topiramate'], 'description': 'Phentermine/Topiramate Top Dose 15 mg/92 mg capsule', 'armGroupLabels': ['VI-0521 Top Dose (Phentermine 15 mg + Topiramate 92 mg)']}, {'name': 'Phentermine', 'type': 'DRUG', 'description': 'Phentermine 30 mg capsule', 'armGroupLabels': ['Phentermine 30mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Inactive oral capsule', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36207', 'city': 'Anniston', 'state': 'Alabama', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 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'geoPoint': {'lat': 46.00382, 'lon': -112.53474}}, {'zip': '27518', 'city': 'Cary', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 35.79154, 'lon': -78.78112}}, {'zip': '97404', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}, {'zip': '29223', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'zip': '37920', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '77546', 'city': 'Friendswood', 'state': 'Texas', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 29.5294, 'lon': -95.20104}}, {'zip': '76180', 'city': 'North Richland Hills', 'state': 'Texas', 'country': 'United States', 'facility': 'Clinical 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