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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
Sponsor:
Information provided by:
AstraZeneca

Study Description
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Brief Summary:
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..

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Coronary Heart Disease Drug: Rosuvastatin Drug: Atorvastatin Phase 3

Study Design
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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

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. To compare the efficacy of rosuvastatin with atorvastatin in modifying other lipids and lipoproteins at week 8

Eligibility Criteria
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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

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


Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Dr. Lawrence Leiter St Michaels hospital, Canada
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Elisabeth Björk, AstraZeneca
ClinicalTrials.gov Identifier: NCT00653588     History of Changes
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

Keywords provided by AstraZeneca:
Cholesterol
low density lipoproteins
Hypercholesterolemia
Coronary Heart Disease
 Rosuvastatin
Crestor
Atorvastatin
Lipitor

Additional relevant MeSH terms:
Heart Diseases
Hypercholesterolemia
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
 Arteriosclerosis
Arterial Occlusive Diseases
Atorvastatin Calcium
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors