Safety and Efficacy Study of BMS-823778 to Treat Uncontrolled High Blood Pressure in Overweight and Obese Patients
This study has suspended participant recruitment.
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01602367
First received: May 17, 2012
Last updated: March 28, 2013
Last verified: October 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension |
Drug: BMS-823778 Drug: Placebo matching with BMS-823778 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- 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 [ Time Frame: At Day -7 (baseline) and Week 12 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in 24-hour ambulatory systolic blood pressure (SBP)(evaluation of the dose-dependent trend) [ Time Frame: At Day -7 (baseline) and Week 12 ] [ Designated as safety issue: No ]
- Change in 24-hour ambulatory diastolic blood pressure (DBP) [ Time Frame: At Day -7 (baseline) and Week 12 ] [ Designated as safety issue: No ]
- Change in 24-hour ambulatory SBP [ Time Frame: At Day -7 (baseline) and Week 12 ] [ Designated as safety issue: No ]
- Change in ambulatory daytime and nighttime DBP [ Time Frame: At Day -7 (baseline) and Week 12 ] [ Designated as safety issue: No ]
- Change in ambulatory daytime and nighttime SBP [ Time Frame: At Day -7 (baseline) and Week 12 ] [ Designated as safety issue: No ]
- Change in seated DBP [ Time Frame: At Day -7 (baseline) and Week 12 ] [ Designated as safety issue: No ]
- Change in seated SBP [ Time Frame: At Day -7 (baseline) and Week 12 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 271 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1: BMS-823778 (2mg) |
Drug: BMS-823778
Capsules, Oral, 2 mg, Once daily, 12 weeks
|
| Experimental: Arm2: BMS-823778 (6mg) |
Drug: BMS-823778
Capsules, Oral, 6 mg, Once daily, 12 weeks
|
| Experimental: Arm 3: BMS-823778 (15mg) |
Drug: BMS-823778
Capsules, Oral, 15 mg, Once daily, 12 weeks
|
| Experimental: Arm4: Placebo |
Drug: Placebo matching with BMS-823778
Capsules, Oral, 0 mg, Once daily, 12 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Qualifying seated blood pressure between ≥ 90 and ≤ 105 mm Hg diastolic AND ≤ 155 mm Hg systolic
- Mean 24-hour diastolic blood pressure ≥ 86 mm Hg
- Body mass index (BMI) ≥ 27 kg/m2
- If receiving an oral anti-hyperglycemic medication or a cholesterol lowering medication, receiving a stable dose for at least 6 weeks
Exclusion Criteria:
- History of Cushing's disease or syndrome, or Addison's disease
- Glycosylated hemoglobin (HbA1c) ≥ 10%
- Cerebrovascular insult, unstable angina, or myocardial infarction (MI) within 6 months
- History of impaired renal or hepatic function
- BMI ≥ 50 kg/m2
- Any injectable antihyperglycemic agent (such as insulin) within 16 weeks of the screening visit
- Currently receiving more than one class of antihypertensive agents within 4 weeks of the screening visit
- Daily use of nonsteroidal anti-inflammatory agents within 1 week of the screening visit
- Use of topical androgen medications within 6 weeks of the screening visit
- Diagnosis or history of breast cancer
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01602367
Locations
| United States, Arkansas | |
| Nea Baptist Clinic | |
| Jonesboro, Arkansas, United States, 72404 | |
| United States, California | |
| Desert Medical Group Inc. | |
| Palm Springs, California, United States, 92262 | |
| United States, New Jersey | |
| Anderson And Collins Clinical Research, Inc. | |
| Edison, New Jersey, United States, 08817 | |
| Premier Research | |
| Trenton, New Jersey, United States, 08611 | |
| United States, New York | |
| Syracuse Preventive Cardiology | |
| Syracuse, New York, United States, 13202 | |
| United States, North Carolina | |
| Metrolina Internal Medicine | |
| Charlotte, North Carolina, United States, 28204 | |
| The Center For Nutrition & Preventive Medicine | |
| Charlotte, North Carolina, United States, 28277 | |
| Pharmquest, Llc | |
| Greensboro, North Carolina, United States, 27408 | |
| Pmg Research Of Salisbury | |
| Salisbury, North Carolina, United States, 28144 | |
| United States, Ohio | |
| Sterling Research Grp, Ltd. | |
| Cincinnati, Ohio, United States | |
| United States, Virginia | |
| Manassas Clinical Research Center | |
| Manassas, Virginia, United States, 20110 | |
| Colombia | |
| Local Institution | |
| Bucaramanga, Colombia, Unspecified | |
| Local Institution | |
| Cartagena, Colombia | |
| Local Institution | |
| Manizales, Colombia, Unspecified | |
| Puerto Rico | |
| Local Institution | |
| Ponce, Puerto Rico, 00717 | |
| Sweden | |
| Local Institution | |
| Odeshog, Sweden, SE-599 31 | |
| Local Institution | |
| Stockholm, Sweden, 141 86 | |
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT01602367 History of Changes |
| Other Study ID Numbers: | MB121-008, 2012‐000509‐54 |
| Study First Received: | May 17, 2012 |
| Last Updated: | March 28, 2013 |
| Health Authority: | United States: Institutional Review Board United States: Food and Drug Administration Mexico: Ministry of Health Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Sweden: Medical Products Agency Hungary: National Institute of Pharmacy European Union: European Medicines Agency |
Additional relevant MeSH terms:
|
Hypertension Overweight Vascular Diseases |
Cardiovascular Diseases Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 22, 2013