NCT04521023已完成4 期
A Randomized, Double-blind, Non-inferiority, Multi-center, Phase 4 Trial to Evaluate the Blood Pressure Lowering Effect of a Candesartan/Hydrochlorothiazide(Candemore Plus® Tab) Versus Candesartan/Amlodipine(Cantabell® Tab) in Hypertensive Patients Inadequately Controlled by Candesartan Monotherapy
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
- 132
- 试验地点
- 14
- 主要终点
- cSBP(central Systolic Blood Pressure)
研究概览
简要总结
Phase 4 clinical trial to Evaluate the blood pressure lowering effect of a Candesartan/Hydrochlorothiazide(Candemore Plus Tab) versus Candesartan/Amlodipine(Cantabell Tab) in Hypertensive Patients
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
- •over 19 years old
- •Agreement with written informed consent
- •Hypertensive Patients
排除标准
- •Patients with secondary hypertension
- •Participated in other trial within 30 days
- •In investigator's judgement
研究组 & 干预措施
A
Experimental
干预措施: Cantabell Tab (Drug)
B
Active Comparator
干预措施: Candemore Plus Tab (Drug)
结局指标
主要结局
cSBP(central Systolic Blood Pressure)
时间窗: change after 8 weeks compared to baseline
Average cSBP change after 8 weeks compared to baseline
次要结局
- cDBP(central Diastolic Blood Pressure)(change after 8 weeks compared to baseline)
- sitSBP(sitting Systolic Blood Pressure)(change after 8 weeks compared to baseline)
- sitDBP(sitting Diastolic Blood Pressure)(change after 8 weeks compared to baseline)
研究者
研究点 (14)
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