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

A 12 Week Randomized, Double-Blind, Force-Titration, Parallel Group, Multi Centre, Phase IIIb Study to Compare the Efficacy of Rosuvastatin With Atorvastatin and Placebo in the Treatment of Non-Diabetic, Non-Atheroscleric, Metabolic Syndrome Subjects With Raised LDL-C and a 10 Year Risk of CHD >10%

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.

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