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

AstraZeneca1,743 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,743

Conditions

Hypercholesterolemia Coronary Heart Disease Atherosclerosis

Interventions

Rosuvastatin (Crestor)DRUG

10mg and 20 mg

EzetimibeDRUG

10 mg

SimvastatinDRUG

40mg and 80 mg

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (9)

Research Site

Brentwood, Tennessee, United States

Research Site

Buenos Aires, Argentina

Research Site

São Paulo, São Paulo, Brazil

Research Site

Santiago, Chile

Outcomes

Primary Outcomes

Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After 6 Weeks Combination Treatment

Percent change in LDL-C = (Combination treatment value - Baseline value)/Baseline value\*100