Polaris - Crestor 40 mg vs Atorvastatin 80 mg for 26 Weeks
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypercholesterolemia; Coronary Heart Disease
Intervention: Rosuvastatin (Drug); Atorvastatin (Drug)
Phase: Phase 3
Sponsored by: AstraZeneca
Official(s) and/or principal investigator(s):
Dr. Lawrence Leiter, Principal Investigator, Affiliation: St Michaels hospital, Canada
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: 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: Treatment, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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
Minimum age: 45 Years.
Maximum age: 75 Years.
- 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.
- 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
Starting date: April 2003
Ending date: October 2004
Last updated: April 4, 2008