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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Dyslipidemia

Treatments: Drug: Muraglitazar

Study type: Interventional

Funder types: Industry

Identifiers

NCT00245388

CV168-008

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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• Treatment with lipid-lowering drugs, unless they can be withdrawn within the following time frame prior to the first qualifying lipid determination (Week 2):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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind