Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
Study NCT ID:
NCT01602367
Status:
TERMINATED
Last Update Posted:
2015-10-12
First Post:
2012-05-17
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of BMS-823778 to Treat Uncontrolled High Blood Pressure in Overweight and Obese Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Argentina', 'Mexico']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000624964', 'term': 'BMS-823778'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'dispFirstSubmitDate': '2015-09-23', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-23', 'studyFirstSubmitDate': '2012-05-17', 'dispFirstSubmitQcDate': '2015-09-23', 'studyFirstSubmitQcDate': '2012-05-18', 'dispFirstPostDateStruct': {'date': '2015-10-12', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-10-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The dose-dependent trend among doses of BMS-823778 and placebo by assessing the change from baseline in 24-hour ambulatory diastolic blood pressure following 12 weeks of double-blind treatment', 'timeFrame': 'At Day -7 (baseline) and Week 12'}], 'secondaryOutcomes': [{'measure': 'Change in 24-hour ambulatory systolic blood pressure (SBP)(evaluation of the dose-dependent trend)', 'timeFrame': 'At Day -7 (baseline) and Week 12'}, {'measure': 'Change in 24-hour ambulatory diastolic blood pressure (DBP)', 'timeFrame': 'At Day -7 (baseline) and Week 12'}, {'measure': 'Change in 24-hour ambulatory SBP', 'timeFrame': 'At Day -7 (baseline) and Week 12'}, {'measure': 'Change in ambulatory daytime and nighttime DBP', 'timeFrame': 'At Day -7 (baseline) and Week 12'}, {'measure': 'Change in ambulatory daytime and nighttime SBP', 'timeFrame': 'At Day -7 (baseline) and Week 12'}, {'measure': 'Change in seated DBP', 'timeFrame': 'At Day -7 (baseline) and Week 12'}, {'measure': 'Change in seated SBP', 'timeFrame': 'At Day -7 (baseline) and Week 12'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bms.com/studyconnect/Pages/home.aspx', 'label': 'BMS clinical trial educational resource'}, {'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether BMS-823778 is safe and effective in the treatment of hypertension in overweight and obese patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Qualifying seated blood pressure between ≥90 and ≤105 mmHg diastolic AND ≤155 mmHg systolic\n* Mean 24-hour diastolic blood pressure ≥85 mmHg\n* Body mass index (BMI) ≥27 kg/m2\n* If receiving an oral anti-hyperglycemic medication or a cholesterol lowering medication, receiving a stable dose for at least 6 weeks\n\nExclusion Criteria:\n\n* History of Cushing's disease or syndrome, or Addison's disease\n* Glycosylated hemoglobin (HbA1c) ≥10%\n* Cerebrovascular insult, unstable angina, or myocardial infarction (MI) within 6 months\n* History of impaired renal or hepatic function\n* BMI ≥50 kg/m2\n* Any injectable antihyperglycemic agent (such as insulin) within 16 weeks\n* Currently receiving more than one class of antihypertensive agents within 4 weeks\n* Daily use of nonsteroidal anti-inflammatory agents within 1 week\n* Use of androgen medications, including topical preparations, within 6 weeks\n* Diagnosis or history of breast cancer"}, 'identificationModule': {'nctId': 'NCT01602367', 'briefTitle': 'Safety and Efficacy Study of BMS-823778 to Treat Uncontrolled High Blood Pressure in Overweight and Obese Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 2B Trial to Evaluate the Safety and Efficacy of BMS-823778 in Overweight and Obese Subjects With Inadequately Controlled Hypertension', 'orgStudyIdInfo': {'id': 'MB121-008'}, 'secondaryIdInfos': [{'id': '2012-000509-54', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1: BMS-823778 (2mg)', 'interventionNames': ['Drug: BMS-823778']}, {'type': 'EXPERIMENTAL', 'label': 'Arm2: BMS-823778 (6mg)', 'interventionNames': ['Drug: BMS-823778']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3: BMS-823778 (15mg)', 'interventionNames': ['Drug: BMS-823778']}, {'type': 'EXPERIMENTAL', 'label': 'Arm4: Placebo', 'interventionNames': ['Drug: Placebo matching with BMS-823778']}], 'interventions': [{'name': 'BMS-823778', 'type': 'DRUG', 'description': 'Capsules, Oral, 2 mg, Once daily, 12 weeks', 'armGroupLabels': ['Arm 1: BMS-823778 (2mg)']}, {'name': 'BMS-823778', 'type': 'DRUG', 'description': 'Capsules, Oral, 6 mg, Once daily, 12 weeks', 'armGroupLabels': ['Arm2: BMS-823778 (6mg)']}, {'name': 'BMS-823778', 'type': 'DRUG', 'description': 'Capsules, Oral, 15 mg, Once daily, 12 weeks', 'armGroupLabels': ['Arm 3: BMS-823778 (15mg)']}, {'name': 'Placebo matching with BMS-823778', 'type': 'DRUG', 'description': 'Capsules, Oral, 0 mg, Once daily, 12 weeks', 'armGroupLabels': ['Arm4: Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Nea Baptist Clinic', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92262', 'city': 'Palm Springs', 'state': 'California', 'country': 'United States', 'facility': 'Desert Medical Group Inc.', 'geoPoint': {'lat': 33.8303, 'lon': -116.54529}}, {'zip': '33134', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '30303', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': 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