Safety Study of BMS-770767 in Subjects With Hypercholesterolemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01058083
First received: January 26, 2010
Last updated: April 18, 2012
Last verified: April 2012
  Purpose

The purpose of this study is to assess the safety, tolerability and pharmacodynamic effects on LDL cholesterol (LDL-C)


Condition Intervention Phase
Dyslipidemia
Drug: BMS-770767
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-Controlled, Parallel-Group, Randomized, Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamic Effects of BMS-770767 in Subjects With Primary Hypercholesterolemia

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Lowering of LDL-C [ Time Frame: Within 28 days following dosing ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics (Blood Level) of BMS-770767 [ Time Frame: Within 28 days following dosing ] [ Designated as safety issue: No ]
  • Pharmacodynamic effects of BMS-770767 on Total cholesterol, HDL-C, Triglycerides, non-HDL-C, non-esterified free fatty acids, Apolipoprotein fractions, HPA axis marker and free testosterone and sex hormone binding globulin (SHBG) [ Time Frame: Within 28 days following dosing ] [ Designated as safety issue: No ]

Enrollment: 81
Study Start Date: May 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BMS-770767 (Treatment A) Drug: BMS-770767
Active, Oral, 15 mg, Daily, 28 days
Experimental: BMS-770767 (Treatment B) Drug: BMS-770767
Active, Oral, 50 mg, Daily, 28 days
Experimental: BMS-770767 (Treatment C) Drug: BMS-770767
Active, Oral, 150 mg, Daily, 28 days
Experimental: BMS-770767 (Treatment D) Drug: BMS-770767
Active, Oral, 50 mg BID, Daily, 28 days
Placebo Comparator: Placebo (Treatment E) Drug: Placebo
Placebo, Oral, 0 mg, daily, 28 days

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hypercholesterolemia
  • Currently taking a stable daily dose of statin therapy
  • Serum triglyceride level < 500mg/dl

Exclusion Criteria

  • History of myocardial infarction, coronary angioplasty or bypass grafts, valvular disease or repair, unstable angina pectoris, transient ischemic attack, or cerebrovascular accidents within six months prior to entry into the study
  • Congestive heart failure
  • Diabetes mellitus
  • Active liver disease
  • Impaired renal function
  • Hepatitis C, B and HIV

This list is not inclusive additional information is provided in the protocol

  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: NCT01058083

Locations
United States, Arkansas
Harrell, Robert
Little Rock, Arkansas, United States, 72201
United States, Texas
Cetero Research - San Antonio
San Antonio, Texas, United States, 78229
Australia, New South Wales
Local Institution
Blacktown, New South Wales, Australia, 2148
Local Institution
Hornsby, New South Wales, Australia, 2077
Australia, Queensland
Local Institution
Caboolture, Queensland, Australia, 4510
Local Institution
South Brisbane, Queensland, Australia, 4101
Australia, South Australia
Local Institution
Daw Park, South Australia, Australia, 5041
Australia, Western Australia
Local Institution
Nedlands, Western Australia, Australia, 6004
Canada, New Brunswick
Local Institution
Bathurst, New Brunswick, Canada, E2A 4X7
Canada, Ontario
Local Institution
Brampton, Ontario, Canada, L6T 3J1
Local Institution
Toronto, Ontario, Canada, M8V 3X8
Canada, Prince Edward Island
Local Institution
Charlottetown, Prince Edward Island, Canada, C1A 5Y9
Canada, Quebec
Local Institution
Mirabel, Quebec, Canada, J7J 2K8
Local Institution
Montreal, Quebec, Canada, H3J 2V5
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: NCT01058083     History of Changes
Other Study ID Numbers: MB117-004, 2009-014306-33
Study First Received: January 26, 2010
Last Updated: April 18, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Canada: Health Canada

Additional relevant MeSH terms:
Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 28, 2014