Safety and Efficacy Study of BMS-823778 to Treat Uncontrolled High Blood Pressure in Overweight and Obese Patients

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Hypertension

In brief

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.

Key facts

Study ID

NCT01602367

Run by

Bristol-Myers Squibb

People needed

7

Starts

2012-07-01

Expected to finish

2012-11-01

Last updated by the study team

2015-10-12

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Qualifying seated blood pressure between ≥90 and ≤105 mmHg diastolic AND ≤155 mmHg systolic
• 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

You may not qualify if…

• 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
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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