COMETS - Compare the Efficacy of Rosuvastatin With Atorvastatin and Placebo in the Treatment of Non-Diabetic, Non-Atheroscleric, Metabolic Syndrome Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

940 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-05-31

Study Completion Date

2005-02-28

Brief Summary

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The purpose of this study is to compare the efficacy of treatment with rosuvastatin with atorvastatin in reducing Low density lipoprotein cholesterol over 6 weeks of treatment in subjects with metabolic syndrome.

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Detailed Description

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Conditions

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Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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1

Rosuvastatin

Group Type EXPERIMENTAL

Rosuvastatin

Intervention Type DRUG

2

Atorvastatin

Group Type ACTIVE_COMPARATOR

Atorvastatin

Intervention Type DRUG

Interventions

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Rosuvastatin

Intervention Type DRUG

Atorvastatin

Intervention Type DRUG

Other Intervention Names

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Crestor Lipitor

Eligibility Criteria

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Inclusion Criteria

* Presence of 3 or more coronary heart disease risk factors as defined by the protocol.
* Fasting low density lipoprotein cholesterol level of \> 130 mg/dL.
* Documented history of, or high risk of coronary heart disease or other established atherosclerotic disease.
* Not previously taken statins.

Exclusion Criteria

* The use of lipid lowering drugs or dietary supplements after Visit 1
* Active arterial disease eg Unstable angina, or recent arterial surgery
* Blood lipid levels above the limits defined in the protocol
* Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No