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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hypertension

Intervention / Treatment
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* Drug: BMS-823778
* Drug: BMS-823778
* Drug: BMS-823778
* Drug: Placebo matching with BMS-823778


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: BMS-823778 (2mg)<br> | Drug: BMS-823778<br>* Capsules, Oral, 2 mg, Once daily, 12 weeks<br>|
| Experimental: Arm2: BMS-823778 (6mg)<br> | Drug: BMS-823778<br>* Capsules, Oral, 6 mg, Once daily, 12 weeks<br>|
| Experimental: Arm 3: BMS-823778 (15mg)<br> | Drug: BMS-823778<br>* Capsules, Oral, 15 mg, Once daily, 12 weeks<br>|
| Experimental: Arm4: Placebo<br> | Drug: Placebo matching with BMS-823778<br>* Capsules, Oral, 0 mg, Once daily, 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |