Safety Study of BMS-770767 in Subjects With Hypercholesterolemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01058083
Recruitment Status : Completed
First Posted : January 28, 2010
Last Update Posted : April 19, 2012
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Dyslipidemia Drug: BMS-770767 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : May 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Lowering of LDL-C [ Time Frame: Within 28 days following dosing ]

Secondary Outcome Measures :
  1. Pharmacokinetics (Blood Level) of BMS-770767 [ Time Frame: Within 28 days following dosing ]
  2. 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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01058083

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
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb Identifier: NCT01058083     History of Changes
Other Study ID Numbers: MB117-004
2009-014306-33 ( Registry Identifier: EUDRACT )
First Posted: January 28, 2010    Key Record Dates
Last Update Posted: April 19, 2012
Last Verified: April 2012

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases