Polaris - Crestor 40 mg vs Atorvastatin 80 mg for 26 Weeks

A 26-Week, Double Blind, Randomised, Multi-Centre, Phase IIIb, Parallel Group Study to Compare the Efficacy and Safety of Rosuvastatin (40 mg) With Atorvastatin (80 mg) in Subjects With Hypercholesterolaemia and Coronary Heart Disease or CHD Risk Equivalents

The purpose of this study is to compare the effect of 8 weeks of treatment with Rosuvastatin with 8 weeks of treatment with Atorvastatin on low density lipoprotein cholesterol level in subjects with hypercholesterolemia and coronary heart disease (CHD) or at high risk of CHD..

Inclusion Criteria:

• A history of CHD or clinical evidence of atherosclerosis or multiple risk factors that confer a high risk as defined in the protocol.
• Fasting LDL-C concentrations at Visit 1 as defined in the protocol.

Exclusion Criteria:

• History of statin induced serious side effects, or serious hypersensitivity reaction to other statins.
• Subjects considered to be unstable by the investigator after the following events: a myocardial infarction (heart attack), unstable angina, myocardial revascularisation or another revascularisation procedure or a transient ischaemic attack (TIA) or stroke.
• Severe congestive cardiac failure (as defined by the protocol - Appendix I).
• Subjects awaiting a planned myocardial revascularisation prior to starting the study (i.e. planned prior to visit 1).