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

September 23, 2015 updated by: Bristol-Myers Squibb

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
      • Barranquilla, Colombia
        • Local Institution
      • Bucaramanga, Colombia
        • Local Institution
      • Cartagena, Colombia
        • Local Institution
      • Manizales, Colombia
        • Local Institution
      • Medellin, Colombia
        • Local Institution
  • Hungary
      • Balatonfured, Hungary, H-8230
        • Local Institution
      • Budapest, Hungary, 1125
        • Local Institution
      • Budapest, Hungary, 1134
        • Local Institution
      • Budapest, Hungary, 1133
        • Local Institution
      • Debrecen, Hungary, 4026
        • Local Institution
  • Puerto Rico
      • Ponce, Puerto Rico, 00717
        • Local Institution
  • Sweden
      • Odeshog, Sweden, 599 31
        • Local Institution
      • Stockholm, Sweden, 141 86
        • Local Institution
  • United States
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • NEA Baptist Clinic
    • California
      • Los Angeles, California, United States, 90057
        • Local Institution
      • Palm Springs, California, United States, 92262
        • Desert Medical Group Inc.
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Local Institution
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Local Institution
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808-4124
        • Pennington Biomedical Research Center
      • New Orleans, Louisiana, United States, 70115
        • Local Institution
    • New Jersey
      • Edison, New Jersey, United States, 08817
        • Anderson and Collins Clinical Research, Inc.
      • Trenton, New Jersey, United States, 08611
        • Premier Research
    • New York
      • Syracuse, New York, United States, 13202-3108
        • Syracuse Preventive Cardiology
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Metrolina Internal Medicine
      • Greensboro, North Carolina, United States, 27408
        • Pharmquest, LLC
      • Salisbury, North Carolina, United States, 28144
        • PMG Research of Salisbury
      • Shelby, North Carolina, United States, 28150
        • Local Institution
      • Shelby, North Carolina, United States, 28152
        • Local Institution
      • Winston-salem, North Carolina, United States, 27103
        • Local Institution
    • Ohio
      • Cincinnati, Ohio, United States, 45246
        • Sterling Research Grp, Ltd.
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Local Institution
    • Utah
      • Layton, Utah, United States, 84041
        • Local Institution
    • Virginia
      • Manassas, Virginia, United States, 20110
        • Manassas Clinical Research Center
      • Norfolk, Virginia, United States, 23502
        • National Clinical Research - Norfolk, Inc.
      • Richmond, Virginia, United States, 23294
        • National Clinical Research - Richmond, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: At Day -7 (baseline) and Week 12
At Day -7 (baseline) and Week 12

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (ACTUAL)

November 1, 2012

Study Completion (ACTUAL)

November 1, 2012

Study Registration Dates

First Submitted

May 17, 2012

First Submitted That Met QC Criteria

May 18, 2012

First Posted (ESTIMATE)

May 21, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

October 12, 2015

Last Update Submitted That Met QC Criteria

September 23, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MB121-008
  • 2012-000509-54 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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