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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00245388

Enrollment

330

Registered

2005-10-28

Start date

2002-04-30

Completion date

2002-07-31

Last updated

2012-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia

Keywords

Mixed Dyslipidemia

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.

Interventions

DRUGMuraglitazar

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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126 mg/dL * Treatment with lipid-lowering drugs, unless they can be withdrawn within the following time frame prior to the first qualifying lipid determination (Week 2): * Niacin or bile-acid binding agents and HMG CoA reductase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

Design outcomes

Primary

Measure	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	—

Secondary

Measure	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	—

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026