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Safety Study of BMS-770767 in Subjects With Hypercholesterolemia

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

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 ]

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

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


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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

  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 identifier: 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
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb Identifier: NCT01058083     History of Changes
Other Study ID Numbers: MB117-004
2009-014306-33 ( Registry Identifier: EUDRACT )
Study First Received: January 26, 2010
Last Updated: April 18, 2012

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases processed this record on August 21, 2017