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

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

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.

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