NCT02955368撤回3 期
A Multi-center, Randomized, Double-blind, Parallel-group Phase III Clinical Trial to Evaluate the Efficacy and Safety of DP-R212 Fixed Dose Combination in Patients With Dyslipidemia and Hypertension
Alvogen Korea0 个研究点开始时间: 2017年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 主要终点
- Change of mean seated Systolic Blood Pressure
研究概览
简要总结
The purpose of this study is to determine superiority of DP-R212 comparing to each monotherapy in patient with hypertension and primary hypercholesterolemia.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both man and woman who is over 19 years old
- •Hypertension patient with hypercholesterolemia
排除标准
- •sSBP difference is ≥20mmHg or sDBP difference is ≥10mmHg
- •A history of cardiovascular disease
- •rhabdomyolysis, myopathy
- •Hypertension or hypercholesterolemia due to secondary causes
- •Uncontrolled diabetes
- •Evidence of hepatic or renal disease
研究组 & 干预措施
DP-R212 group
Experimental
DP-R212 + C1-R212 placebo + C2-R212 placebo
干预措施: DP-R212 (Drug)
C1-R212 group
Active Comparator
DP-R212 placebo + C1-R212 + C2-R212 placebo
干预措施: C1-R212 (Drug)
C2-R212 group
Active Comparator
DP-R212 placebo + C1-R212 placebo + C2-R212
干预措施: C2-R212 (Drug)
结局指标
主要结局
Change of mean seated Systolic Blood Pressure
时间窗: 0, 8 weeks
Percent change of LDL-Cholesterol
时间窗: 0, 8 weeks
次要结局
未报告次要终点
研究者
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