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
  Purpose

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 Intervention Phase
Hypertension
Drug: BMS-823778
Drug: Placebo matching with BMS-823778
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 7
Study Start Date: July 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01602367

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

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01602367     History of Changes
Other Study ID Numbers: MB121-008, 2012‐000509‐54
Study First Received: May 17, 2012
Last Updated: August 23, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration
Mexico: Ministry of Health
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Sweden: Medical Products Agency
Hungary: National Institute of Pharmacy
European Union: European Medicines Agency

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

ClinicalTrials.gov processed this record on October 19, 2014