NCT02280590已完成4 期
Comparison of the Efficacy and Safety of Cresnon® and Crestor® in Patients With Hyperlipidemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 223
- 试验地点
- 1
- 主要终点
- The percent change in LDL-C
研究概览
简要总结
Comparison of the efficacy and safety of Cresnon® and Crestor® in patients with hyperlipidemia
- 8-week, active-controlled, open-label, randomized, parallelgroup, fixed-dose, noninferiority, multicenter, phase 4 design
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persons who have not reached LDL-C targeted level in accordance with the treatment guidelines for dyslipidemia released by Korean Society of Lipidology and Atherosclerosis
排除标准
- 未提供
研究组 & 干预措施
Cresnon®
Experimental
Rosuvastatin 10mg, tablet, q.d.
干预措施: Rosuvastatin(Cresnon®) (Drug)
Crestor®
Active Comparator
Rosuvastatin 10mg, tablet, q.d.
干预措施: Rosuvastatin(Crestor®) (Drug)
结局指标
主要结局
The percent change in LDL-C
时间窗: After taken medication for 8 weeks
次要结局
- The proportion of subjects reaching LDL-C targeted level in accordance with the treatment guidelines for dyslipidemia released by Korean Society of Lipidology and Atherosclerosis(After taken medication for 8 weeks)
- The percent change in total cholesterol, Triglyceride, HDL-C, non-HDL-C, and non-HDL-C/HDL-C(After taken medication for 8 weeks)
研究者
研究点 (1)
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