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

• Status: Terminated
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb

Criteria

Inclusion Criteria:

• 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

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

• 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