Official Title: “A 12-Week Open-Label, Randomised, Parallel-Group, Multicentre, Phase IIIb Study to Compare the Efficacy and Safety of Rosuvastatin (CRESTOR™) in Combination With Ezetimibe and Simvastatin in Patients With Hypercholesterolaemia and CHD”

The purpose of this study is to determine whether treatment of Rosuvastatin (CRESTOR™) or Simvastatin given as monotherapy or given in combination with Ezetimibe, will lower the Low Density Lipoprotein Cholesterol (LDL-C) in patients with Hypercholesterolaemia and Coronary Heart Disease (CHD) or a CHD Risk Equivalent, Atherosclerosis or a 10-year CHD Risk of >20%

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Rosuvastatin (Crestor)
  • 10mg and 20 mg
• Drug: Ezetimibe
  • 10 mg
• Drug: Simvastatin
  • 40mg and 80 mg

Primary Measures

• The primary efficacy variable is the change in LDL-C relative to the baseline value. Change can be expressed as a percentage change. The primary variable is assessed after 6 wks of combination treatment

Secondary Measures

• The secondary outcome variables include: o LDL-C, HDL-C, TC, TG, nonHDL-C, ApoB, ApoA-I, TC/HDL-C, LDLC/HDL-C, nonHDL-C/HDL-C and ApoB/ApoA-I, hs-CRP; and the corresponding measures of effects are the respective changes from baseline

Inclusion Criteria:

• Patients with with hypercholesterolaemia and CHD or a CHD risk equivalent, clinical evidence of atherosclerosis or a Framingham 10-year CHD risk score of >20
• Patients will need to sign an informed consent before any visit procedures can be performed, including procedures for the optional genetic research and biomarker studies.
• Patients must be 18 years or older and will be asked to stop taking any current cholesterol-lowering medications. Dietary counselling will be provided which will include an overview of the Therapeutic Lifestyle Change (TLC) diet the patients will be asked to follow

Exclusion Criteria:

• Use of lipid lowering drugs and other prohibited concomitant medications. History of statin-induced myopathy, or serious hypersensitivity reaction to other HMG-CoA reductase inhibitors (statins), including rosuvastatin, simvastatin and/or a history of hypersensitivity to any components of ezetimibe.
• Patients considered to be unstable by their physician after the following events:
• a myocardial infarction, recent episode of unstable angina, myocardial revascularisation
• [percutaneous transluminal coronary angioplasty (PTCA), coronary artery bypass graft (CABG) surgery or another revascularisation procedure] or a transient ischaemic attack (TIA) or stroke and patients awaiting a planned myocardial revascularisation

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Christie M Ballantyne, MD FACP FACC Principal Investigator Centre for Cardiovascular Disease Prevention  

Overall Contact: AstraZeneca Clinical Study, Information 1-800-236-9933 information.center@astrazeneca.com

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00525824

Study ID Number: D356FC00003

ClinicalTrials.gov Identifier: NCT00525824

Health Authority: United States: Food and Drug Administration