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

Study Overview
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Brief Summary
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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..

Official Title
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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

Conditions
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Hypercholesterolemia, Coronary Heart Disease

Intervention / Treatment
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* Drug: Rosuvastatin
* Drug: Atorvastatin


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>rosuvastatin (40 mg) | Drug: Rosuvastatin<br>* 40mg<br>* Other names: Crestor;|
| Active Comparator: 2<br>atorvastatin (80 mg) | Drug: Atorvastatin<br>* 80mg<br>* Other names: Lipitor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the efficacy of rosuvastatin with atorvastatin by assessing the percentage change from baseline to week 8 in LDL-C concentrations in subjects with hypercholesterolaemia and CHD or CHD risk equivalents. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the efficacy of rosuvastatin with atorvastatin in modifying other lipids and lipoproteins at week 8 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cholesterol, low density lipoproteins, Hypercholesterolemia, Coronary Heart Disease, Rosuvastatin, Crestor, Atorvastatin, Lipitor