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

Completed · Phase 3

Conditions studied: Hypercholesterolemia, Coronary Heart Disease, Atherosclerosis

In brief

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%

Key facts

Study ID: NCT00525824
Run by: AstraZeneca
People needed: 1743
Starts: 2007-08-01
Expected to finish: 2008-09-01
Last updated by the study team: 2011-05-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Research Site — Brentwood, Tennessee, United States
Research Site — Buenos Aires, Argentina
Research Site — São Paulo, São Paulo, Brazil
Research Site — Santiago, Chile
Research Site — Brentwood, Colombia
Research Site — Brentwood, Lithuania
Research Site — Zwinderen, Netherlands
Research Site — Lima, San Isidro Lima, Peru
Research Site — Brentwood, Venezuela

Full record on ClinicalTrials.gov

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