Safety and Efficacy Study of BMS-823778 to Treat Uncontrolled High Blood Pressure in Overweight and Obese Patients
NCT ID: NCT01602367
Last Updated: 2015-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
7 participants
INTERVENTIONAL
2012-07-31
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm 1: BMS-823778 (2mg)
BMS-823778
Capsules, Oral, 2 mg, Once daily, 12 weeks
Arm2: BMS-823778 (6mg)
BMS-823778
Capsules, Oral, 6 mg, Once daily, 12 weeks
Arm 3: BMS-823778 (15mg)
BMS-823778
Capsules, Oral, 15 mg, Once daily, 12 weeks
Arm4: Placebo
Placebo matching with BMS-823778
Capsules, Oral, 0 mg, Once daily, 12 weeks
Interventions
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BMS-823778
Capsules, Oral, 2 mg, Once daily, 12 weeks
BMS-823778
Capsules, Oral, 6 mg, Once daily, 12 weeks
BMS-823778
Capsules, Oral, 15 mg, Once daily, 12 weeks
Placebo matching with BMS-823778
Capsules, Oral, 0 mg, Once daily, 12 weeks
Eligibility Criteria
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Inclusion Criteria
* Mean 24-hour diastolic blood pressure ≥85 mmHg
* 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
* 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
* Currently receiving more than one class of antihypertensive agents within 4 weeks
* Daily use of nonsteroidal anti-inflammatory agents within 1 week
* Use of androgen medications, including topical preparations, within 6 weeks
* Diagnosis or history of breast cancer
18 Years
80 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Nea Baptist Clinic
Jonesboro, Arkansas, United States
Local Institution
Los Angeles, California, United States
Desert Medical Group Inc.
Palm Springs, California, United States
Local Institution
Coral Gables, Florida, United States
Local Institution
Atlanta, Georgia, United States
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States
Local Institution
New Orleans, Louisiana, United States
Anderson And Collins Clinical Research, Inc.
Edison, New Jersey, United States
Premier Research
Trenton, New Jersey, United States
Syracuse Preventive Cardiology
Syracuse, New York, United States
Metrolina Internal Medicine
Charlotte, North Carolina, United States
Pharmquest, Llc
Greensboro, North Carolina, United States
Pmg Research Of Salisbury
Salisbury, North Carolina, United States
Local Institution
Shelby, North Carolina, United States
Local Institution
Shelby, North Carolina, United States
Local Institution
Winston-Salem, North Carolina, United States
Sterling Research Grp, Ltd.
Cincinnati, Ohio, United States
Local Institution
Greenville, South Carolina, United States
Local Institution
Layton, Utah, United States
Manassas Clinical Research Center
Manassas, Virginia, United States
National Clinical Research - Norfolk, Inc.
Norfolk, Virginia, United States
National Clinical Research - Richmond, Inc.
Richmond, Virginia, United States
Local Institution
Barranquilla, , Colombia
Local Institution
Bucaramanga, , Colombia
Local Institution
Cartagena, , Colombia
Local Institution
Manizales, , Colombia
Local Institution
Medellín, , Colombia
Local Institution
Balatonfüred, , Hungary
Local Institution
Budapest, , Hungary
Local Institution
Budapest, , Hungary
Local Institution
Budapest, , Hungary
Local Institution
Debrecen, , Hungary
Local Institution
Ponce, , Puerto Rico
Local Institution
Ödeshög, , Sweden
Local Institution
Stockholm, , Sweden
Countries
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Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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2012-000509-54
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MB121-008
Identifier Type: -
Identifier Source: org_study_id
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