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

• Status: Completed
• Trial end date: 2002-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Pravastatin

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• Treatment with lipid-lowering drugs, unless they can be withdrawn within the following time frame prior to the first qualifying lipid determination (Week 2):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