A Randomized, Double-Blind, Placebo Controlled, Multicenter, Phase 3 Study of Rosuvastatin (CRESTOR®) 20 mg in the Prevention of Cardiovascular Events Among Subjects With Low Levels of Low Density Lipoprotein(LDL) Cholesterol & Elevated Levels of C-Reactive Protein
概览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 17,802
- 试验地点
- 1
- 主要终点
- Time to Major Cardiac Event (Cardiovascular Death, Stroke, Myocardial Infarction, Hospitalization Due to Unstable Angina or Arterial Revascularization)
概览
简要总结
The purpose of this study is to determine the safety and effectiveness of long-term therapy with rosuvastatin compared with a placebo, and to evaluate whether treatment with rosuvastatin might be effective in reducing the risk of major cardiovascular events.
详细描述
AstraZeneca announced it has decided to stop the CRESTOR JUPITER clinical study early based on a recommendation from an Independent Data Monitoring Board and the JUPITER Steering Committee, which met on March 29, 2008. The study will be stopped early because there is unequivocal evidence of a reduction in cardiovascular morbidity and mortality amongst patients who received CRESTOR when compared to placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men 50 years or older, women 60 years or older
- •Low to normal levels of low density lipoprotein (LDL) cholesterol (\< 130mg/dL)
- •Elevated levels of C-Reactive Protein (CRP) \> 2.0 mg/L
排除标准
- •History of cardiovascular or cerebrovascular events
- •Active liver disease
- •Diabetes mellitus
- •Uncontrolled hypertension or hypothyroidism
- •History of certain malignancies
- •Chronic inflammatory conditions
- •History of alcohol or drug abuse
研究组 & 干预措施
Rosuvastatin
Rosuvastatin 20 mg once daily
干预措施: Rosuvastatin (Drug)
Placebo
Placebo once daily
干预措施: Placebo (Other)
结局指标
主要结局
Time to Major Cardiac Event (Cardiovascular Death, Stroke, Myocardial Infarction, Hospitalization Due to Unstable Angina or Arterial Revascularization)
时间窗: up to 5 years
Days from randomization to the first of CV death, stroke, MI, hospitalization for unstable angina or arterial revascularization. If no event, censoring occurs at earliest of termination date or efficacy cut-off date of 30 Mar 2008. Events were adjudicated by an endpoint committee. Kaplan-Meier estimate of the mean
次要结局
- Time to Non-cardiovascular Death(up to 5 years)
- Time to Death Due to Any Cause(up to 5 years)
- Time to Development of Diabetes Mellitus(up to 5 years)
- Time to Venous Thromboembolic Event(up to 5 years)
- Time to Bone Fracture(Up to 5 years)