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

NCT01602367 | Terminated Phase 2

• 2 other identifiers: MB121-0082012-000509-54
• Study Type: interventional
• Target: 7
• Locations: 5 countries
• Sites: 35

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 (7)

• 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

Study Arms (4)

Arm 1: BMS-823778 (2mg)

EXPERIMENTAL

Drug: BMS-823778

Arm2: BMS-823778 (6mg)

EXPERIMENTAL

Drug: BMS-823778

Arm 3: BMS-823778 (15mg)

EXPERIMENTAL

Drug: BMS-823778

Arm4: Placebo

EXPERIMENTAL

Drug: Placebo matching with BMS-823778

Interventions

BMS-823778 DRUG

Capsules, Oral, 2 mg, Once daily, 12 weeks

Arm 1: BMS-823778 (2mg)

Placebo matching with BMS-823778 DRUG

Capsules, Oral, 0 mg, Once daily, 12 weeks

Arm4: Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (35)

Nea Baptist Clinic

Jonesboro, Arkansas, 72401, United States

Location

Local Institution

Los Angeles, California, 90057, United States

Location

Desert Medical Group Inc.

Palm Springs, California, 92262, United States

Location

Local Institution

Coral Gables, Florida, 33134, United States

Location

Local Institution

Atlanta, Georgia, 30303, United States

Location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808-4124, United States

Location

Local Institution

New Orleans, Louisiana, 70115, United States

Location

Anderson And Collins Clinical Research, Inc.

Edison, New Jersey, 08817, United States

Location

Premier Research

Trenton, New Jersey, 08611, United States

Location

Syracuse Preventive Cardiology

Syracuse, New York, 13202-3108, United States

Location

Metrolina Internal Medicine

Charlotte, North Carolina, 28204, United States

Location

Pharmquest, Llc

Greensboro, North Carolina, 27408, United States

Location

Pmg Research Of Salisbury

Salisbury, North Carolina, 28144, United States

Location

Local Institution

Shelby, North Carolina, 28150, United States

Location

Local Institution

Shelby, North Carolina, 28152, United States

Location

Local Institution

Winston-Salem, North Carolina, 27103, United States

Location

Sterling Research Grp, Ltd.

Cincinnati, Ohio, 45246, United States

Location

Local Institution

Greenville, South Carolina, 29615, United States

Location

Local Institution

Layton, Utah, 84041, United States

Location

Manassas Clinical Research Center

Manassas, Virginia, 20110, United States

Location

National Clinical Research - Norfolk, Inc.

Norfolk, Virginia, 23502, United States

Location

National Clinical Research - Richmond, Inc.

Richmond, Virginia, 23294, United States

Location

Local Institution

Barranquilla, Colombia

Location

Local Institution

Bucaramanga, Colombia

Location

Local Institution

Cartagena, Colombia

Location

Local Institution

Manizales, Colombia

Location

Local Institution

Medellín, Colombia

Location

Local Institution

Balatonfüred, H-8230, Hungary

Location

Local Institution

Budapest, 1125, Hungary

Location

Local Institution

Budapest, 1133, Hungary

Location

Local Institution

Budapest, 1134, Hungary

Location

Local Institution

Debrecen, 4026, Hungary

Location

Local Institution

Ponce, 00717, Puerto Rico

Location

Local Institution

Ödeshög, 599 31, Sweden

Location

Local Institution

Stockholm, 141 86, Sweden

Location

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Conditions

Hypertension

Interventions

BMS-823778

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2012
• First Posted: May 21, 2012
• Study Start: July 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: October 12, 2015

Record last verified: 2015-09

Locations

SE (2); PR (1); US (22); CO (5); HU (5)