NCT00389896已完成3 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Balanced, Three-Way Crossover Study to Evaluate the Efficacy of Simvastatin Therapy in Elevating HDL-C Levels in Patients With Type 2 Diabetic Dyslipidemia and Low HDL-C
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 150
- 主要终点
- HDL-C raising effects after 6 weeks
研究概览
简要总结
The purpose of this study is to see how well simvastatin raises HDL levels in patients with Type 2 Diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
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
- •Patient has stable Type 2 diabetes mellitus at Visit
- •Patient meets screening criteria based on Visit 1 lab tests
排除标准
- •Patient is pregnant, breastfeeding, or at risk of becoming pregnant
- •Patient has heart disease, uncontrolled high blood pressure, or other significant disease
- •Patient is taking prohibited medication(s) and is unable to stop taking them for the duration of the study
结局指标
主要结局
HDL-C raising effects after 6 weeks
时间窗: 6 weeks
次要结局
- Effect on other lipids and lipoproteins at 6 weeks(6 weeks)
研究者
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