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

Dyslipidemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00245388
• Other study ID #: CV168-008
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 14, 2005
• Last updated: April 20, 2012
• Start date: April 2002
• Est. completion date: July 2002

Study information

• Verified date: April 2012
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: July 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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• Treatment with lipid-lowering drugs, unless they can be withdrawn within the following time frame prior to the first qualifying lipid determination (Week 2):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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

Drug:
• Muraglitazar

Locations

Country	Name	City	State
Canada	Local Institution	Ottawa	Ontario
United States	Local Institution	Austin	Texas
United States	Local Institution	Baltimore	Maryland
United States	Local Institution	Bend	Oregon
United States	Local Institution	Bethesda	Maryland
United States	Local Institution	Clearwater	Florida
United States	Local Institution	Columbus	Ohio
United States	Local Institution	Cooper City	Florida
United States	Local Institution	Dallas	Texas
United States	Local Institution	Deland	Florida
United States	Local Institution	Dunwoody	Georgia
United States	Local Institution	Edina	Minnesota
United States	Local Institution	Greer	South Carolina
United States	Local Institution	Hickory	North Carolina
United States	Local Institution	Hillsboro	Oregon
United States	Local Institution	Indianapolis	Indiana
United States	Local Institution	Inverness	Florida
United States	Local Institution	Iowa City	Iowa
United States	Local Institution	Irvine	California
United States	Local Institution	Kansas City	Missouri
United States	Local Institution	Little Rock	Arkansas
United States	Local Institution	Long Beach	California
United States	Local Institution	Longmont	Colorado
United States	Local Institution	Longwood	Florida
United States	Local Institution	Louisville	Kentucky
United States	Local Institution	Manlius	New York
United States	Local Institution	Marrero	Louisiana
United States	Local Institution	Melbourne	Georgia
United States	Local Institution	Minneapolis	Minnesota
United States	Local Institution	Mount Pleasant	South Carolina
United States	Local Institution	Olympia	Washington
United States	Local Institution	Overland Park	Kansas
United States	Local Institution	Pembroke Pines	Florida
United States	Local Institution	Peoria	Illinois
United States	Local Institution	Philadelphia	Pennsylvania
United States	Local Institution	Phoenix	Arizona
United States	Local Institution	Portland	Oregon
United States	Local Institution	Raleigh	California
United States	Local Institution	Roseville	California
United States	Local Institution	Sacramento	California
United States	Local Institution	Saint Louis	Missouri
United States	Local Institution	San Angelo	Texas
United States	Local Institution	San Antonio	Texas
United States	Local Institution	San Diego	California
United States	Local Institution	Santa Ana	California
United States	Local Institution	Sarasota	Florida
United States	Local Institution	Seattle	Washington
United States	Local Institution	Sellersville	Pennsylvania
United States	Local Institution	Stuart	Florida
United States	Local Institution	Toms River	New Jersey
United States	Local Institution	Warminster	Pennsylvania
United States	Local Institution	Wichita	Kansas
United States	Local Institution	Winston-Salem	North Carolina
United States	Local Institution	Yakima	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm