Clinical trial NCT00245388: Efficacy and Safety of BMS-298585 Alone or in Combination With Pravastatin in Subjects With Mixed Dyslipidemia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Dyslipidemia
Keywords: Mixed Dyslipidemia
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2005-10-28
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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* Treatment with lipid-lowering drugs, unless they can be withdrawn within the following time frame prior to the first qualifying lipid determination (Week 2):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

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