NCT00141141已完成4 期
A Phase IV, Multicenter, Randomized, Open Label Study To Evaluate The Efficacy And Safety Of Atorvastatin Versus Simvastatin In Type 2 Diabetic Subjects With Hypercholesterolemia
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.36 个研究点 分布在 1 个国家目标入组 383 人开始时间: 2004年1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
- 383
- 试验地点
- 36
- 主要终点
- To evaluate the decrease of LDL-C after 24 weeks of treatment.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of Atorvastin vs Simvastatin in decreasing LDL-C in diabetic subjects with hypercholesterolemia at the end of the treatment phase.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of type 2 diabetes mellitus
- •LDL-C > 130 mg/dL
排除标准
- •Insulin therapy
- •Clinically relevant organ disease (creatininemia >2mg/dL, CHF NYHA III and IV)
结局指标
主要结局
To evaluate the decrease of LDL-C after 24 weeks of treatment.
次要结局
- To evaluate the changes from baseline of targeted blood markers.
- To evaluate safety of Atorvastatin vs Simvastatin
研究者
研究点 (36)
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