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
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 April 22, 2014