NCT03482180已完成3 期
A Multi-Center, Randomized, Double-Blind, Parallel Phase III Study to Evaluate the Efficacy and Safety of KI1106 in Patients Whose TG Level is Not Adequately Controlled With Atorvastatin Calcium Monotherapy While LDL-C is Properly Controlled
Kuhnil Pharmaceutical Co., Ltd.0 个研究点目标入组 215 人开始时间: 2016年5月4日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 215
- 主要终点
- Variation rate of Non HDL-C
研究概览
简要总结
To examine variation rate of Non-HDL with KI1106 comparison Atorvastatin monotherapy.
详细描述
Randomly assigned to two groups (KI1106 or Atorvastatin monotherapy) after 4 weeks run-in period and prescribed KI1106 or Atorvastatin for 8 weeks.
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
- Double (Participant, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Investigational Group- KI1106
Experimental
KI1106 tablet - daily administration
干预措施: KI1106 4g, QD (Drug)
Control Group - Atorvastatin
Active Comparator
Atorvastatin Calcium 20mg - daily administration
干预措施: Atorvastatin Calcium 20mg, QD (Drug)
结局指标
主要结局
Variation rate of Non HDL-C
时间窗: 8 weeks
次要结局
- Variation rate of TG(4 weeks, 8 weeks)
- Variation rate of Non HDL-C(4 weeks)
- Variation rate of TC(4 weeks, 8 weeks)
- Variation rate of LDL-C(4 weeks, 8 weeks)
- Variation rate of VLDL-C(4 weeks, 8 weeks)
- Variation rate of Apo A-I(4 weeks, 8 weeks)
- Variation rate of Apo B(4 weeks, 8 weeks)
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