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

Completed · Phase 2/Phase 3

Conditions studied: Dyslipidemia

In brief

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.

Key facts

Study ID

NCT00245388

Run by

Bristol-Myers Squibb

People needed

330

Starts

2002-04-01

Expected to finish

2002-07-01

Last updated by the study team

2012-04-23

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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• Treatment with lipid-lowering drugs, unless they can be withdrawn within the following time frame prior to the first qualifying lipid determination (Week 2):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

Where it is running

• Local Institution — Little Rock, Arkansas, United States
• Local Institution — 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 — Longmont, Colorado, United States
• Local Institution — 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 — Dunwoody, Georgia, United States
• Local Institution — Melbourne, Georgia, United States
• Local Institution — Peoria, Illinois, United States
• Local Institution — Indianapolis, Indiana, United States
• Local Institution — Iowa City, Iowa, United States
• Local Institution — Overland Park, Kansas, United States
• Local Institution — Wichita, Kansas, United States
• Local Institution — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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