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

Status:	Terminated
Conditions:	High Blood Pressure (Hypertension), Obesity Weight Loss
Therapuetic Areas:	Cardiology / Vascular Diseases, Endocrinology
Healthy:	No
Age Range:	18 - 80
Updated:	4/21/2016
Start Date:	July 2012
End Date:	November 2012

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

We found this trial at

sites

Local Institution

Atlanta, Georgia 30342

from

Atlanta, GA