Safety Study of BMS-770767 in Subjects With Hypercholesterolemia

April 18, 2012 updated by: Bristol-Myers Squibb

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Blacktown, New South Wales, Australia, 2148
        • Local Institution
      • Hornsby, New South Wales, Australia, 2077
        • Local Institution
    • Queensland
      • Caboolture, Queensland, Australia, 4510
        • Local Institution
      • South Brisbane, Queensland, Australia, 4101
        • Local Institution
    • South Australia
      • Daw Park, South Australia, Australia, 5041
        • Local Institution
    • Western Australia
      • Nedlands, Western Australia, Australia, 6004
        • Local Institution
  • Canada
    • New Brunswick
      • Bathurst, New Brunswick, Canada, E2A 4X7
        • Local Institution
    • Ontario
      • Brampton, Ontario, Canada, L6T 3J1
        • Local Institution
      • Toronto, Ontario, Canada, M8V 3X8
        • Local Institution
    • Prince Edward Island
      • Charlottetown, Prince Edward Island, Canada, C1A 5Y9
        • Local Institution
    • Quebec
      • Mirabel, Quebec, Canada, J7J 2K8
        • Local Institution
      • Montreal, Quebec, Canada, H3J 2V5
        • Local Institution
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72201
        • Harrell, Robert
    • Texas
      • San Antonio, Texas, United States, 78229
        • Cetero Research - San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BMS-770767 (Treatment A)
Drug: BMS-770767
Active, Oral, 15 mg, Daily, 28 days
Drug: BMS-770767
Active, Oral, 50 mg, Daily, 28 days
Drug: BMS-770767
Active, Oral, 150 mg, Daily, 28 days
Drug: BMS-770767
Active, Oral, 50 mg BID, Daily, 28 days
Experimental: BMS-770767 (Treatment B)
Drug: BMS-770767
Active, Oral, 15 mg, Daily, 28 days
Drug: BMS-770767
Active, Oral, 50 mg, Daily, 28 days
Drug: BMS-770767
Active, Oral, 150 mg, Daily, 28 days
Drug: BMS-770767
Active, Oral, 50 mg BID, Daily, 28 days
Experimental: BMS-770767 (Treatment C)
Drug: BMS-770767
Active, Oral, 15 mg, Daily, 28 days
Drug: BMS-770767
Active, Oral, 50 mg, Daily, 28 days
Drug: BMS-770767
Active, Oral, 150 mg, Daily, 28 days
Drug: BMS-770767
Active, Oral, 50 mg BID, Daily, 28 days
Experimental: BMS-770767 (Treatment D)
Drug: BMS-770767
Active, Oral, 15 mg, Daily, 28 days
Drug: BMS-770767
Active, Oral, 50 mg, Daily, 28 days
Drug: BMS-770767
Active, Oral, 150 mg, Daily, 28 days
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Lowering of LDL-C
Time Frame: Within 28 days following dosing
Within 28 days following dosing

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics (Blood Level) of BMS-770767
Time Frame: Within 28 days following dosing
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
Within 28 days following dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

January 26, 2010

First Submitted That Met QC Criteria

January 26, 2010

First Posted (Estimate)

January 28, 2010

Study Record Updates

Last Update Posted (Estimate)

April 19, 2012

Last Update Submitted That Met QC Criteria

April 18, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MB117-004
  • 2009-014306-33 (Registry Identifier: EUDRACT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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