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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01602367
Recruitment Status : Terminated
First Posted : May 21, 2012
Last Update Posted : October 12, 2015
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: BMS-823778 Drug: Placebo matching with BMS-823778 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2012
Primary Completion Date : November 2012
Study Completion Date : November 2012

Arm Intervention/treatment
Experimental: Arm 1: BMS-823778 (2mg) Drug: BMS-823778
Capsules, Oral, 2 mg, Once daily, 12 weeks
Experimental: Arm2: BMS-823778 (6mg) Drug: BMS-823778
Capsules, Oral, 6 mg, Once daily, 12 weeks
Experimental: Arm 3: BMS-823778 (15mg) 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

Primary Outcome Measures :
  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 [ Time Frame: At Day -7 (baseline) and Week 12 ]

Secondary Outcome Measures :
  1. Change in 24-hour ambulatory systolic blood pressure (SBP)(evaluation of the dose-dependent trend) [ Time Frame: At Day -7 (baseline) and Week 12 ]
  2. Change in 24-hour ambulatory diastolic blood pressure (DBP) [ Time Frame: At Day -7 (baseline) and Week 12 ]
  3. Change in 24-hour ambulatory SBP [ Time Frame: At Day -7 (baseline) and Week 12 ]
  4. Change in ambulatory daytime and nighttime DBP [ Time Frame: At Day -7 (baseline) and Week 12 ]
  5. Change in ambulatory daytime and nighttime SBP [ Time Frame: At Day -7 (baseline) and Week 12 ]
  6. Change in seated DBP [ Time Frame: At Day -7 (baseline) and Week 12 ]
  7. Change in seated SBP [ Time Frame: At Day -7 (baseline) and Week 12 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01602367

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

Additional Information:
Responsible Party: Bristol-Myers Squibb Identifier: NCT01602367     History of Changes
Other Study ID Numbers: MB121-008
2012‐000509‐54 ( EudraCT Number )
First Posted: May 21, 2012    Key Record Dates
Last Update Posted: October 12, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Body Weight
Signs and Symptoms