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

Primary Purpose

Dyslipidemia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Muraglitazar
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemia focused on measuring Mixed Dyslipidemia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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126 mg/dL Treatment with lipid-lowering drugs, unless they can be withdrawn within the following time frame prior to the first qualifying lipid determination (Week 2): Niacin or bile-acid binding agents and HMG CoA reductase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

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Outcomes

Primary Outcome Measures

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 Outcome Measures

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

Full Information

First Posted
October 14, 2005
Last Updated
April 20, 2012
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00245388
Brief Title
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

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2002 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia
Keywords
Mixed Dyslipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
330 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Muraglitazar
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Facility Information:
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Phoenix
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Arizona
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United States
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Little Rock
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Arkansas
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United States
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Irvine
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California
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United States
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Long Beach
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California
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United States
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Raleigh
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California
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United States
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Roseville
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United States
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Sacramento
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United States
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San Diego
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United States
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Santa Ana
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California
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United States
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Longmont
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Colorado
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United States
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Clearwater
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Florida
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United States
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Cooper City
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United States
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Deland
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United States
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Inverness
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United States
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Longwood
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United States
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Pembroke Pines
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Sarasota
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Stuart
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United States
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Dunwoody
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Georgia
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Melbourne
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Georgia
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Peoria
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Indianapolis
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Iowa City
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Overland Park
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Wichita
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Louisville
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Marrero
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Baltimore
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Bethesda
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Edina
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Minneapolis
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Kansas City
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Saint Louis
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Toms River
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Manlius
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Hickory
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United States
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Winston-Salem
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Columbus
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Bend
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Hillsboro
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Portland
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Philadelphia
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Sellersville
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Warminster
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Greer
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Mount Pleasant
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Austin
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Dallas
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San Angelo
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San Antonio
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Olympia
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Seattle
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Yakima
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Ottawa
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Ontario
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Canada

12. IPD Sharing Statement

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

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