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

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ClinicalTrials.gov Identifier: NCT01602367
Recruitment Status : Terminated
First Posted : May 21, 2012
Last Update Posted : October 12, 2015
Sponsor:
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

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

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 ClinicalTrials.gov identifier (NCT number): NCT01602367


  Show 35 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov 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:
Hypertension
Overweight
Vascular Diseases
Cardiovascular Diseases
Body Weight
Signs and Symptoms