NCT01564875Unknown4 期
Efficacy and Safety of Morning Intake of Simvast Controlled Release (CR) Tablet Versus Evening Intake of Zocor Tablet in Chronic Kidney Disease Stage(CKD)3, 4 and 5 Patients With Hyperlipidemia: A Randomized, Double-blind, Multicenter Phase 4 Trial (HM-SIM4)
Hanmi Pharmaceutical Company Limited7 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2010年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 122
- 试验地点
- 7
- 主要终点
- Percent change of LDL-C
研究概览
简要总结
Study design
- Multicenter, double-dummy, double-blinded, randomized, Phase 4 study
- Patients will be randomized to either a study group or a control group in a 1:1 ratio, and will be orally administered the assigned drugs
Study Objective
-The study is designed to demonstrate that efficacy and safety of morning dosing of Simvast Controlled Release (CR) Tab is not inferior to evening dosing of Zocor Tab in patients with stage 3,4,5 chronic kidney disease with hyperlipidemia
Primary objective
-to assess the percent change of LDL-C at Week 8 from baseline in Chronic Kidney Disease(CKD) stage 3,4,5 with hyperlipidemia subjects.
详细描述
The secondary objectives of the study are as follows:
- to assess the change and percent change of TC, HDL-C, TG from baseline.
- to assess the accomplishment rate of therapeutic goals based on the therapeutic guidance for hyperlipidemia of the Korean Society of Lipidology and Atherosclerosis.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Simvast CR
Experimental
- Simvast CR Tab 20mg, 1 tablet once daily to be administered between 6 and 9 a.m.
- Placebo with the same appearance and formulation as that of Zocor Tab, 1 tablet once daily to be administered between 6 and 9 p.m.
干预措施: Simvast CR (Drug)
Zocor
Active Comparator
- Placebo with the same appearance and formulation as that of Simvast CR Tab, 1 tablet once daily to be administered between 6 and 9 a.m.
- Zocor Tab 20mg, 1 tablet once daily to be administered between 6 and 9 p.m.
干预措施: Zocor (Drug)
结局指标
主要结局
Percent change of LDL-C
时间窗: 8 weeks
Percent change of LDL-C at Week 8 from baseline
次要结局
- Change and percent change of TC, HDL-C, TG(8 weeks)
- Accomplishment rate of therapeutic goals(8 weeks)
研究者
研究点 (7)
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