NCT00846118终止不适用
Differential Intervention Trial by Standard Therapy Versus Pitavastatin in Patients With Chronic Hemodialysis.
Chieko Hamada1 个研究点 分布在 1 个国家目标入组 905 人开始时间: 2009年2月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 905
- 试验地点
- 1
- 主要终点
- all cause mortality
研究概览
简要总结
The purpose of this study is to verify whether pitavastatin prevents from cardiovascular events and improves the mortality in chronic hemodialysis patients with hypercholesteremia.
详细描述
It was already proved by the clinical trials that statins prevent from death and cardiovascular events. However, the efficacy of statins in patients with chronic hemodialysis has not been proved yet.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients under hemodialysis
- •patients with hypercholesterolemia as defined by any of following parameters:
- •LDL-C ≧ 100 mg / dL
- •TC ≧ 180 mg / dL
- •patients required cholesterol-lowering treatment by investigators.
- •patients aged 20-75 years
- •patients with written consent by their own volition after being provided sufficient explanation for the participation into this clinical trial
排除标准
- •patients taking statins or fibrates
- •patients enrolled to the other trials using contraindication drugs of pitavastatin
- •patients who had acute myocardial infarction within six months before the day of the agreement acquisition
- •patients scheduled PCI and CABG within six months after the day of the agreement acquisition
- •Patients who had diagnosis or doubt of malignant tumor
- •patients corresponded to "Contraindications" of pitavastatin
- •Familial hypercholesterolemia patients
- •patients judged ineligible by investigators
研究组 & 干预措施
Pitavastatin
Active Comparator
Pitavastatin in addition to optimal standard care
干预措施: Pitavastatin (Drug)
结局指标
主要结局
all cause mortality
时间窗: whole observational period
Myocardial infarction of the new onset
时间窗: whole observational period
次要结局
- Cardiac death(whole observational period)
- Myocardial infarction of the new onset(whole observational period)
研究者
Chieko Hamada
Division of Nehprology
Juntendo University
研究点 (1)
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