Efficacy and Safety of BMS-298585 Alone or in Combination With Pravastatin in Subjects With Mixed Dyslipidemia
Phase 2
Completed
- Conditions
- Dyslipidemia
- Registration Number
- NCT00245388
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 330
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Treatment with lipid-lowering drugs, unless they can be withdrawn within the following time frame prior to the first qualifying lipid determination (Week 2):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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (1)
Local Institution
🇨🇦Ottawa, Ontario, Canada