Status:
COMPLETED
Efficacy and Safety of BMS-298585 Alone or in Combination With Pravastatin in Subjects With Mixed Dyslipidemia
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Dyslipidemia
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
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 sub...
Eligibility Criteria
Inclusion
- Non-diabetics
- Serum TG \>150 mg/dL and \< or = 600 mg/dL
- Serum LDL-C \>130 mg/dL
Exclusion
- 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- Treatment with lipid-lowering drugs, unless they can be withdrawn within the following time frame prior to the first qualifying lipid determination (Week 2):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
Key Trial Info
Start Date :
April 1 2002
Trial Type :
INTERVENTIONAL
End Date :
July 1 2002
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT00245388
Start Date
April 1 2002
End Date
July 1 2002
Last Update
April 23 2012
Active Locations (54)
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1
Local Institution
Phoenix, Arizona, United States
2
Local Institution
Little Rock, Arkansas, United States
3
Local Institution
Irvine, California, United States
4
Local Institution
Long Beach, California, United States