Polaris - Crestor 40 mg vs Atorvastatin 80 mg for 26 Weeks (POLARIS)
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ClinicalTrials.gov Identifier: NCT00653588 |
Recruitment Status :
Completed
First Posted : April 7, 2008
Last Update Posted : March 16, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypercholesterolemia Coronary Heart Disease | Drug: Rosuvastatin Drug: Atorvastatin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | April 2003 |
Actual Study Completion Date : | September 2004 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
rosuvastatin (40 mg)
|
Drug: Rosuvastatin
40mg
Other Name: Crestor |
Active Comparator: 2
atorvastatin (80 mg)
|
Drug: Atorvastatin
80mg
Other Name: Lipitor |
- 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.
- To compare the efficacy of rosuvastatin with atorvastatin in modifying other lipids and lipoproteins at week 8

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Ages Eligible for Study: | 45 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00653588
Principal Investigator: | Dr. Lawrence Leiter | St Michaels hospital, Canada |
Responsible Party: | Elisabeth Björk, AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00653588 |
Other Study ID Numbers: |
4522IL/0106 D3569C00005 |
First Posted: | April 7, 2008 Key Record Dates |
Last Update Posted: | March 16, 2009 |
Last Verified: | March 2009 |
Cholesterol low density lipoproteins Hypercholesterolemia Coronary Heart Disease |
Rosuvastatin Crestor Atorvastatin Lipitor |
Heart Diseases Coronary Disease Coronary Artery Disease Myocardial Ischemia Hypercholesterolemia Cardiovascular Diseases Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Vascular Diseases |
Arteriosclerosis Arterial Occlusive Diseases Atorvastatin Rosuvastatin Calcium Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |