Open-Label Non-Interventional Evaluation of Efficacy of Crestor® (Rosuvastatin) in Reduction of LDL-Cholesterol and Cardiovascular Risk Parameters in Patients With Hypercholesterolaemia

AstraZeneca0 个研究点目标入组 602 人开始时间: 2007年1月最近更新: 2009年2月6日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: AstraZeneca
入组人数: 602
主要终点: LDL-cholesterol reduction

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

This open label, non-interventional study is to show the efficacy of Crestor (rosuvastatin) in reduction of LDL-cholesterol and cardiovascular risk parameters in patients with hypercholesterolemia. Effectiveness is to be evaluated using the difference in LDL cholesterol level between the first and the second visit after 12 weeks.

研究设计

研究类型: Observational
时间视角: Prospective

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•a patient with hypercholesterolemia who has been prescribed Crestoraccording to physician's judgement, irrespective of the inclusion in the study.
•no treatment with any statin in the last 3 months

排除标准

•hypersensitivity to rosuvastatin or any other ingredient of Crestor
•active liver disease, severe renal insufficiency
•myopathy or predisposing risk factors for myopathy/ rhabdomyolysis
•woman of child-bearing potential and not using appropriate contraceptive measures, pregnancy or lactation

结局指标

主要结局

LDL-cholesterol reduction

时间窗: 12 weeks

次要结局

achievement of target levels of total cholesterol and LDL-cholesterol(12 weeks)
patient compliance(12 weeks)
change in coronary risk(12 weeks)

研究者

发起方

AstraZeneca

申办方类型

Industry

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