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

Phase 2

Terminated

• Conditions: Hypertension
• Interventions: Drug: BMS-823778; Drug: Placebo matching with BMS-823778

• Registration Number: NCT01602367
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-05-17
• Study First Submitted QC: 2012-05-18
• Study First Posted: 2012-05-21
• Study Start: 2012-07
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2015-09
• Disposition First Submitted: 2015-09-23
• Disposition First Submitted QC: 2015-09-23
• Last Update Submitted: 2015-09-23
• Disposition First Posted: 2015-10-12
• Last Update Posted: 2015-10-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm2: BMS-823778 (6mg)	BMS-823778	-
Arm 3: BMS-823778 (15mg)	BMS-823778	-
Arm 1: BMS-823778 (2mg)	BMS-823778	-
Arm4: Placebo	Placebo matching with BMS-823778	-

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (14)

Premier Research; 🇺🇸 Trenton, New Jersey, United States

Pharmquest, Llc; 🇺🇸 Greensboro, North Carolina, United States

Manassas Clinical Research Center; 🇺🇸 Manassas, Virginia, United States

National Clinical Research - Norfolk, Inc.; 🇺🇸 Norfolk, Virginia, United States

National Clinical Research - Richmond, Inc.; 🇺🇸 Richmond, Virginia, United States

Nea Baptist Clinic; 🇺🇸 Jonesboro, Arkansas, United States

Local Institution; 🇸🇪 Stockholm, Sweden

Desert Medical Group Inc.; 🇺🇸 Palm Springs, California, United States

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States

Syracuse Preventive Cardiology; 🇺🇸 Syracuse, New York, United States

Metrolina Internal Medicine; 🇺🇸 Charlotte, North Carolina, United States

Sterling Research Grp, Ltd.; 🇺🇸 Cincinnati, Ohio, United States

Pmg Research Of Salisbury; 🇺🇸 Salisbury, North Carolina, United States

Anderson And Collins Clinical Research, Inc.; 🇺🇸 Edison, New Jersey, United States