Polaris - Crestor 40 mg vs Atorvastatin 80 mg for 26 Weeks
Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypercholesterolemia; Coronary Heart Disease
Intervention: Rosuvastatin (Drug); Atorvastatin (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s): Dr. Lawrence Leiter, Principal Investigator, Affiliation: St Michaels hospital, Canada
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..
Clinical Details
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 design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: 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: To compare the efficacy of rosuvastatin with atorvastatin in modifying other lipids and lipoproteins at week 8
Eligibility
Minimum age: 45 Years.
Maximum age: 75 Years.
Gender(s): Both.
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).
Locations and Contacts
Additional Information
Starting date: April 2003
Last updated: March 13, 2009
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