NCT00211705已完成4 期
Management of Elevated Cholesterol in the Primary Prevention Group of Adult Japanese(MEGA Study)
Mitsukoshi Health and Welfare Foundation0 个研究点目标入组 8,000 人开始时间: 1994年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8,000
- 主要终点
- Coronary Heart Disease(CHD)[fatal/non-fatal MI, sudden/cardiac death, angina, revascularization]
研究概览
简要总结
To evaluate the primary preventive effect of low-dose pravastatin against coronary heart disease (CHD) in Japanese hypercholesterolemic patients.
详细描述
MEGA Study is the first prospective, randomized, controlled trial conducted in Japan to evaluate the primary preventive effect of pravastatin against CHD in daily clinical practice. Because the dose of pravastatin used in the MEGA Study was 10-20 mg/day, which is consistent with the approved doses in Japan and lower than the doses used in previous large-scale clinical trials.
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
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •TC:220～270mg/dl
- •Male: 40-70 years old/ female: postmenopausal-70 years old
- •<40kg in weight
排除标准
- •History of CHD(angina, MI, post-PTCA/CABG, etc.)
- •History of CVA(stroke, TIA, etc.)
- •Underlying malignant tumor
结局指标
主要结局
Coronary Heart Disease(CHD)[fatal/non-fatal MI, sudden/cardiac death, angina, revascularization]
次要结局
- Stroke, cerebrovascular infarction(CI), CHD+CI, all cardiovascular events, total mortality
研究者
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