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”

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..

Study Type: Interventional

Study Design: Treatment, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: September 2004

Intervention(s) in this Clinical Trial

• Drug: Rosuvastatin
  • 40mg
• Drug: Atorvastatin
  • 80mg

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • rosuvastatin (40 mg)
• Active Comparator: 2
  • atorvastatin (80 mg)

Primary Measures

• 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 Measures

• To compare the efficacy of rosuvastatin with atorvastatin in modifying other lipids and lipoproteins at week 8

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).

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 45 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Dr. Lawrence Leiter Principal Investigator St Michaels hospital, Canada  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00653588

Study ID Number: 4522IL/0106

ClinicalTrials.gov Identifier: NCT00653588

Health Authority: United States: Food and Drug Administration