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

• BMS-823778 (Drug): Capsules, Oral, 2 mg, Once daily, 12 weeks
• BMS-823778 (Drug): Capsules, Oral, 6 mg, Once daily, 12 weeks
• BMS-823778 (Drug): Capsules, Oral, 15 mg, Once daily, 12 weeks
• Placebo matching with BMS-823778 (Drug): Capsules, Oral, 0 mg, Once daily, 12 weeks

Primary outcomes

• 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 [At Day -7 (baseline) and Week 12]

Secondary outcomes

• Change in 24-hour ambulatory systolic blood pressure (SBP)(evaluation of the dose-dependent trend) [At Day -7 (baseline) and Week 12]
• Change in 24-hour ambulatory diastolic blood pressure (DBP) [At Day -7 (baseline) and Week 12]
• Change in 24-hour ambulatory SBP [At Day -7 (baseline) and Week 12]
• Change in ambulatory daytime and nighttime DBP [At Day -7 (baseline) and Week 12]
• Change in ambulatory daytime and nighttime SBP [At Day -7 (baseline) and Week 12]
• Change in seated DBP [At Day -7 (baseline) and Week 12]
• Change in seated SBP [At Day -7 (baseline) and Week 12]

Sex: All, ages: 18 Years to 80 Years

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

• Bristol-Myers Squibb, Study director, Bristol-Myers Squibb