NCT03103256已完成3 期
A Multi-center, Randomized, Double-blind, Parallel-group Phase III Clinical Trial to Evaluate the Efficacy and Safety of YHP1701 Fixed Dose Combination in Patients With Dyslipidemia and Hypertension
Yuhan Corporation1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2017年5月17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
- 106
- 试验地点
- 1
- 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 YHP1701 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
- •Patient with dyslipidemia and hypertension
排除标准
- •sSBP difference is ≥20 mmHg or sDBP difference is ≥10 mmHg
- •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
YHR1703
Active Comparator
PO, Once daily (QD), 8 weeks
干预措施: YHR1703 (Drug)
YHP1701
Experimental
PO, Once daily (QD), 8 weeks
干预措施: YHP1701 (Drug)
YHR1704
Active Comparator
PO, Once daily (QD), 8 weeks
干预措施: YHR1704 (Drug)
结局指标
主要结局
Change of mean seated Systolic Blood Pressure
时间窗: 0, 8 weeks
Blood Pressure
Percent change of LDL-Cholesterol
时间窗: 0, 8 weeks
LDL-Cholesterol
次要结局
未报告次要终点
研究者
研究点 (1)
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