Efficacy and Safety of BMS-298585 Alone or in Combination With Pravastatin in Subjects With Mixed Dyslipidemia

April 20, 2012 updated by: Bristol-Myers Squibb

A Randomized, Double-Blind, Dose-Ranging, Placebo-Controlled Trial to Determine the Lipid-Lowering Efficacy and Safety of BMS-298585 Alone or in Combination With Pravastatin in Subjects With Mixed Dyslipidemia

This is a randomized, double-blind, dose-ranging, placebo-controlled trial to determine the lipid-lowering efficacy and safety of BMS-298585 (muraglitazar) alone in combination with pravastatin in subjects with mixed dyslipidemia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

330

Phase

  • Phase 2
  • Phase 3

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

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada
        • Local Institution
  • United States
    • Arizona
      • Phoenix, Arizona, United States
        • Local Institution
    • Arkansas
      • Little Rock, Arkansas, United States
        • Local Institution
    • California
      • Irvine, California, United States
        • Local Institution
      • Long Beach, California, United States
        • Local Institution
      • Raleigh, California, United States
        • Local Institution
      • Roseville, California, United States
        • Local Institution
      • Sacramento, California, United States
        • Local Institution
      • San Diego, California, United States
        • Local Institution
      • Santa Ana, California, United States
        • Local Institution
    • Colorado
      • Longmont, Colorado, United States
        • Local Institution
    • Florida
      • Clearwater, Florida, United States
        • Local Institution
      • Cooper City, Florida, United States
        • Local Institution
      • Deland, Florida, United States
        • Local Institution
      • Inverness, Florida, United States
        • Local Institution
      • Longwood, Florida, United States
        • Local Institution
      • Pembroke Pines, Florida, United States
        • Local Institution
      • Sarasota, Florida, United States
        • Local Institution
      • Stuart, Florida, United States
        • Local Institution
    • Georgia
      • Dunwoody, Georgia, United States
        • Local Institution
      • Melbourne, Georgia, United States
        • Local Institution
    • Illinois
      • Peoria, Illinois, United States
        • Local Institution
    • Indiana
      • Indianapolis, Indiana, United States
        • Local Institution
    • Iowa
      • Iowa City, Iowa, United States
        • Local Institution
    • Kansas
      • Overland Park, Kansas, United States
        • Local Institution
      • Wichita, Kansas, United States
        • Local Institution
    • Kentucky
      • Louisville, Kentucky, United States
        • Local Institution
    • Louisiana
      • Marrero, Louisiana, United States
        • Local Institution
    • Maryland
      • Baltimore, Maryland, United States
        • Local Institution
      • Bethesda, Maryland, United States
        • Local Institution
    • Minnesota
      • Edina, Minnesota, United States
        • Local Institution
      • Minneapolis, Minnesota, United States
        • Local Institution
    • Missouri
      • Kansas City, Missouri, United States
        • Local Institution
      • Saint Louis, Missouri, United States
        • Local Institution
    • New Jersey
      • Toms River, New Jersey, United States
        • Local Institution
    • New York
      • Manlius, New York, United States
        • Local Institution
    • North Carolina
      • Hickory, North Carolina, United States
        • Local Institution
      • Winston-Salem, North Carolina, United States
        • Local Institution
    • Ohio
      • Columbus, Ohio, United States
        • Local Institution
    • Oregon
      • Bend, Oregon, United States
        • Local Institution
      • Hillsboro, Oregon, United States
        • Local Institution
      • Portland, Oregon, United States
        • Local Institution
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Local Institution
      • Sellersville, Pennsylvania, United States
        • Local Institution
      • Warminster, Pennsylvania, United States
        • Local Institution
    • South Carolina
      • Greer, South Carolina, United States
        • Local Institution
      • Mount Pleasant, South Carolina, United States
        • Local Institution
    • Texas
      • Austin, Texas, United States
        • Local Institution
      • Dallas, Texas, United States
        • Local Institution
      • San Angelo, Texas, United States
        • Local Institution
      • San Antonio, Texas, United States
        • Local Institution
    • Washington
      • Olympia, Washington, United States
        • Local Institution
      • Seattle, Washington, United States
        • Local Institution
      • Yakima, Washington, United States
        • Local Institution

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Non-diabetics
  • Serum TG >150 mg/dL and < or = 600 mg/dL
  • Serum LDL-C >130 mg/dL

Exclusion Criteria:

  • Type 1 or type 2 diabetics
  • Fasting plasma glucose >126 mg/dL

  • Treatment with lipid-lowering drugs, unless they can be withdrawn within the following time frame prior to the first qualifying lipid determination (Week 2):

    • Niacin or bile-acid binding agents and HMG CoA reductase inhibitors: 8 weeks
    • Fibrates: 8 weeks
    • Probucol: 1 year
  • History of active liver disease and/or history of thiazolidinedione-related (troglitazone, rosiglitazone, or pioglitazone) liver abnormalities, hepatic dysfunction, or jaundice

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: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To compare at a .05 level of significance, after 6 weeks of oral administration of double-blind treatment the percent change from baseline to average triglycerides (TG), week 5-6 between 5, 10 and 20 mg

Secondary Outcome Measures

Outcome Measure
Percent changes from baseline to average at week 5-6 of total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), non-HDL-C, apolipoprotein A1 (ApoA1), and free fatty acid (FFA) levels

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

April 1, 2002

Study Completion (Actual)

July 1, 2002

Study Registration Dates

First Submitted

October 14, 2005

First Submitted That Met QC Criteria

October 26, 2005

First Posted (Estimate)

October 28, 2005

Study Record Updates

Last Update Posted (Estimate)

April 23, 2012

Last Update Submitted That Met QC Criteria

April 20, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV168-008

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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