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Clinical Trials/NCT00245388
NCT00245388CompletedPhase 2

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

Bristol-Myers Squibb54 sites in 2 countries330 target enrollmentStarted: April 1, 2002Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Enrollment
330
Locations
54
Primary Endpoint
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
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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  • •Treatment with lipid-lowering drugs, unless they can be withdrawn within the following time frame prior to the first qualifying lipid determination (Week 2):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

Outcomes

Primary Outcomes

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 Outcomes

  • 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

Investigators

Sponsor
Bristol-Myers Squibb
Sponsor Class
Industry

Study Sites (54)

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