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

AstraZeneca940 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

940

Conditions

Metabolic Syndrome

Interventions

RosuvastatinDRUG

AtorvastatinDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Low density lipoprotein cholesterol levels following treatment in subjects with metabolic syndrome.

Time frame: At 6 & 12 weeks

Secondary Outcomes

Modification of other lipids and lipoproteins

Time frame: At 6 & 12 weeks

Modification of insulin resistance, inflammatory markers & glucose metabolism

Time frame: At 6 & 12 weeks

Safety: adverse events & abnormal laboratory markers

Time frame: At 6 & 12 weeks

Data from ClinicalTrials.gov

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