临床试验/NCT00657527

NCT00657527已完成3 期

An 8-Week Randomized Double Blind Placebo Controlled Multicenter Trial to Evaluate the Effects of Rosuvastatin 40mg on Myocardial Ischemia in Subjects With Coronary Artery Disease.

AstraZeneca0 个研究点目标入组 280 人开始时间: 2001年12月最近更新: 2009年3月16日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方: AstraZeneca
入组人数: 280
主要终点: Number of episodes of myocardial ischaemia as assessed by ambulatory electrocardiographic monitoring.

研究概览研究设计入排标准研究组 & 干预措施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

The purpose of this study is to determine whether treatment with 40mg of Rosuvastatin for 8 weeks will reduce the number of episodes of myocardial ischaemia suffered in subjects with coronary artery disease.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Triple (Participant, Care Provider, Investigator)

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

•Evidence of Coronary arterial disease
•Suffering ischaemic episodes/exercise induced ischaemia
•Not taking any cholesterol lowering medication

排除标准

•Unstable angina or heart attack less than one month before trial entry
•Coronary arterial surgery as defined by protocol
•Uncontrolled hypertension, diabetes, hypothyroidism or laboratory values as defined by the protocol.

研究组 & 干预措施

2

No Intervention

Diet

干预措施: Cholesterol lowering diet (Behavioral)

1

Experimental

Rosuvastatin

干预措施: Rosuvastatin (Drug)

结局指标

主要结局

Number of episodes of myocardial ischaemia as assessed by ambulatory electrocardiographic monitoring.

时间窗: 8 weekly

次要结局

Change in duration of ischemic episodes(8 weekly)
Safety(8 weekly)
Several laboratory parameters as detailed in the protocol(8 weekly)

研究者

发起方

AstraZeneca

申办方类型

Industry

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