12-Week Open-Label, Phase IIIb Comparing Efficacy and Safety of Rosuvastatin (CRESTOR™) in Combination With Ezetimibe

Condition(s) targeted: Hypercholesterolemia; Coronary Heart Disease; Atherosclerosis

Intervention: Rosuvastatin (Crestor) (Drug); Ezetimibe (Drug); Simvastatin (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Christie M Ballantyne, MD FACP FACC, Principal Investigator, Affiliation: Centre for Cardiovascular Disease Prevention
Margareta Grind, MD PhD FFPM, Study Chair, Affiliation: Medicine and Sciences AstraZeneca

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

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%

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

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

Primary outcome: 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 outcome: 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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

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

Research Site, Buenos Aires, Argentina; Not yet recruiting

Research Site, Santiago, Chile; Not yet recruiting

Research Site, Brentwood, Colombia; Not yet recruiting

Research Site, Brentwood, Lithuania; Not yet recruiting

Research Site, Zwinderen, Netherlands; Not yet recruiting

Research Site, Brentwood, Venezuela; Not yet recruiting

Research Site, Sao Paulo, SP, Brazil; Not yet recruiting

Research Site, Lima, San Isidro Lima, Peru; Not yet recruiting

Research Site, Brentwood, Tennessee, United States; Recruiting

Starting date: August 2007
Last updated: April 3, 2008