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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Muraglitazar | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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Treatment with lipid-lowering drugs, unless they can be withdrawn within the following time frame prior to the first qualifying lipid determination (Week 2):
History of active liver disease and/or history of thiazolidinedione-related (troglitazone, rosiglitazone, or pioglitazone) liver abnormalities, hepatic dysfunction, or jaundice
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Phoenix | Arizona | United States | |||
| Local Institution |
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| 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 | Louisville | Kentucky | United States |
| Local Institution | Marrero | Louisiana | United States |
| Local Institution | Baltimore | Maryland | United States |
| Local Institution | Bethesda | Maryland | United States |
| Local Institution | Edina | Minnesota | United States |
| Local Institution | Minneapolis | Minnesota | United States |
| Local Institution | Kansas City | Missouri | United States |
| Local Institution | St Louis | Missouri | United States |
| Local Institution | Toms River | New Jersey | United States |
| Local Institution | Manlius | New York | United States |
| Local Institution | Hickory | North Carolina | United States |
| Local Institution | Winston-Salem | North Carolina | United States |
| Local Institution | Columbus | Ohio | United States |
| Local Institution | Bend | Oregon | United States |
| Local Institution | Hillsboro | Oregon | United States |
| Local Institution | Portland | Oregon | United States |
| Local Institution | Philadelphia | Pennsylvania | United States |
| Local Institution | Sellersville | Pennsylvania | United States |
| Local Institution | Warminster | Pennsylvania | United States |
| Local Institution | Greer | South Carolina | United States |
| Local Institution | Mt. Pleasant | South Carolina | United States |
| Local Institution | Austin | Texas | United States |
| Local Institution | Dallas | Texas | United States |
| Local Institution | San Angelo | Texas | United States |
| Local Institution | San Antonio | Texas | United States |
| Local Institution | Olympia | Washington | United States |
| Local Institution | Seattle | Washington | United States |
| Local Institution | Yakima | Washington | United States |
| Local Institution | Ottawa | Ontario | Canada |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C500085 | muraglitazar |
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