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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01602367
First received: May 17, 2012
Last updated: August 23, 2013
Last verified: August 2013

May 17, 2012
August 23, 2013
July 2012
November 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01602367 on ClinicalTrials.gov Archive Site
  • Change in 24-hour ambulatory systolic blood pressure (SBP)(evaluation of the dose-dependent trend) [ Time Frame: At Day -7 (baseline) and Week 12 ] [ Designated as safety issue: No ]
  • Change in 24-hour ambulatory diastolic blood pressure (DBP) [ Time Frame: At Day -7 (baseline) and Week 12 ] [ Designated as safety issue: No ]
  • Change in 24-hour ambulatory SBP [ Time Frame: At Day -7 (baseline) and Week 12 ] [ Designated as safety issue: No ]
  • Change in ambulatory daytime and nighttime DBP [ Time Frame: At Day -7 (baseline) and Week 12 ] [ Designated as safety issue: No ]
  • Change in ambulatory daytime and nighttime SBP [ Time Frame: At Day -7 (baseline) and Week 12 ] [ Designated as safety issue: No ]
  • Change in seated DBP [ Time Frame: At Day -7 (baseline) and Week 12 ] [ Designated as safety issue: No ]
  • Change in seated SBP [ Time Frame: At Day -7 (baseline) and Week 12 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy Study of BMS-823778 to Treat Uncontrolled High Blood Pressure in Overweight and Obese Patients
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hypertension
  • 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
  • Drug: Placebo matching with BMS-823778
    Capsules, Oral, 0 mg, Once daily, 12 weeks
  • Experimental: Arm 1: BMS-823778 (2mg)
    Intervention: Drug: BMS-823778
  • Experimental: Arm2: BMS-823778 (6mg)
    Intervention: Drug: BMS-823778
  • Experimental: Arm 3: BMS-823778 (15mg)
    Intervention: Drug: BMS-823778
  • Experimental: Arm4: Placebo
    Intervention: Drug: Placebo matching with BMS-823778
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
7
November 2012
November 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Colombia,   Hungary,   Sweden,   Puerto Rico
 
NCT01602367
MB121-008, 2012‐000509‐54
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP