Efficacy and Safety of BMS-298585 Alone or in Combination With Pravastatin in Subjects With Mixed Dyslipidemia
A Randomized, Double-Blind, Dose-Ranging, Placebo-Controlled Trial to Determine the Lipid-Lowering Efficacy and Safety of BMS-298585 Alone or in Combination With Pravastatin in Subjects With Mixed Dyslipidemia
1 other identifier
interventional
330
2 countries
54
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2002
Shorter than P25 for phase_2
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2002
CompletedFirst Submitted
Initial submission to the registry
October 14, 2005
CompletedFirst Posted
Study publicly available on registry
October 28, 2005
CompletedApril 23, 2012
April 1, 2012
October 14, 2005
April 20, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Interventions
Eligibility Criteria
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- Treatment with lipid-lowering drugs, unless they can be withdrawn within the following time frame prior to the first qualifying lipid determination (Week 2):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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (54)
Local Institution
Phoenix, Arizona, United States
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Little Rock, Arkansas, United States
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Irvine, California, United States
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Long Beach, California, United States
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Raleigh, California, United States
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Roseville, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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Santa Ana, California, United States
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Longmont, Colorado, United States
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Clearwater, Florida, United States
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Cooper City, Florida, United States
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DeLand, Florida, United States
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Inverness, Florida, United States
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Longwood, Florida, United States
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Pembroke Pines, Florida, United States
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Sarasota, Florida, United States
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Stuart, Florida, United States
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Dunwoody, Georgia, United States
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Melbourne, Georgia, United States
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Peoria, Illinois, United States
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Indianapolis, Indiana, United States
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Iowa City, Iowa, United States
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Overland Park, Kansas, United States
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Wichita, Kansas, United States
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Louisville, Kentucky, United States
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Marrero, Louisiana, United States
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Baltimore, Maryland, United States
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Bethesda, Maryland, United States
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Edina, Minnesota, United States
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Minneapolis, Minnesota, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Toms River, New Jersey, United States
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Manlius, New York, United States
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Hickory, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Columbus, Ohio, United States
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Bend, Oregon, United States
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Hillsboro, Oregon, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Sellersville, Pennsylvania, United States
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Warminster, Pennsylvania, United States
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Greer, South Carolina, United States
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Mt. Pleasant, South Carolina, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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San Angelo, Texas, United States
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San Antonio, Texas, United States
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Olympia, Washington, United States
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Seattle, Washington, United States
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Yakima, Washington, United States
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Ottawa, Ontario, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 14, 2005
First Posted
October 28, 2005
Study Start
April 1, 2002
Study Completion
July 1, 2002
Last Updated
April 23, 2012
Record last verified: 2012-04