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

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 2

Conditions: Hypertension

Treatments: Drug: BMS-823778; Drug: Placebo matching with BMS-823778

Study type: Interventional

Funder types: Industry

Identifiers

NCT01602367

MB121-008

2012-000509-54 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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7 participants in 4 patient groups

Arm 1: BMS-823778 (2mg)

Experimental group

Treatment:

Drug: BMS-823778

Drug: BMS-823778

Drug: BMS-823778

Arm2: BMS-823778 (6mg)

Experimental group

Treatment:

Drug: BMS-823778

Drug: BMS-823778

Drug: BMS-823778

Arm 3: BMS-823778 (15mg)

Experimental group

Treatment:

Drug: BMS-823778

Drug: BMS-823778

Drug: BMS-823778

Arm4: Placebo

Experimental group

Treatment:

Drug: Placebo matching with BMS-823778