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

• Status: Completed
• Trial end date: 2005-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Atorvastatin; Atorvastatin Calcium; Rosuvastatin Calcium

Criteria

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