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

CompletadoFase 3ClinicalTrials.gov

ID: NCT00525824Tipo: INTERVENTIONALInicio: 1 de ago de 2007Fin estimado: 1 de sept de 2008

Traducción no disponible, mostrando original

Resumen

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%

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

drug

Rosuvastatin (Crestor)

10mg and 20 mg

drug

Ezetimibe

10 mg

drug

Simvastatin

40mg and 80 mg

Ubicaciones

Research Site

Buenos Aires, Argentina

Patrocinadores

PrincipalAstraZeneca

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