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

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ClinicalTrials.gov Identifier: NCT00245388
Recruitment Status : Completed
First Posted : October 28, 2005
Last Update Posted : April 23, 2012
Sponsor:
Information provided by:
Bristol-Myers Squibb

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dyslipidemia Drug: Muraglitazar Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2002
Actual Study Completion Date : July 2002

Resource links provided by the National Library of Medicine

Drug Information available for: Pravastatin
U.S. FDA Resources




Primary Outcome Measures :
  1. 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 :
  1. 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


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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  • Treatment with lipid-lowering drugs, unless they can be withdrawn within the following time frame prior to the first qualifying lipid determination (Week 2):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

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 ClinicalTrials.gov identifier (NCT number): NCT00245388


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Sponsors and Collaborators
Bristol-Myers Squibb

Additional Information:
ClinicalTrials.gov Identifier: NCT00245388     History of Changes
Other Study ID Numbers: CV168-008
First Posted: October 28, 2005    Key Record Dates
Last Update Posted: April 23, 2012
Last Verified: April 2012

Keywords provided by Bristol-Myers Squibb:
Mixed Dyslipidemia

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Pravastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors