NCT03897868已完成2 期
A Muticenter, Randomized, Double-blind, Parallel, Phase 2 Study to Assess Dose-response Relationship of HCP1803 in Patients With Essential Hypertension
Hanmi Pharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 248 人开始时间: 2019年3月21日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 248
- 试验地点
- 1
- 主要终点
- Change from baseline in sitting systolic blood pressure
研究概览
简要总结
A multicenter, randomized, double-blind, parallel, phase 2 study to assess dose-response relationship of HCP1803 in patients with essential hypertension
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
- •Patient with essential hypertension who meet 140 mmHg ≤ mean sitSBP < 180 mmHg and mean sitDBP < 110 mmHg at Visit 1, Visit 2
排除标准
- •Patient with differences between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP at Visit 1
- •Patient with difference of ≥ 15 mmHg in mean sitSBP between Visit 1 and Visit 2
- •Patient with mean sitSBP ≥ 180 mmHg or mean sitDBP ≥ 110 mmHg at Visit 1, Visit 2
- •Patient with secondary hypertension
研究组 & 干预措施
Experimental 1
Experimental
HCP1803 High
干预措施: HCP1803 (Drug)
Experimental 1
Experimental
HCP1803 High
干预措施: Placebo (Drug)
Experimental 2
Experimental
HCP1803 Middle
干预措施: HCP1803 (Drug)
Experimental 2
Experimental
HCP1803 Middle
干预措施: Placebo (Drug)
Experimental 3
Experimental
HCP1803 Low
干预措施: HCP1803 (Drug)
Experimental 3
Experimental
HCP1803 Low
干预措施: Placebo (Drug)
Active Comparator 1
Active Comparator
HGP0904 High
干预措施: Amlodipine (Drug)
Active Comparator 2
Active Comparator
HGP0904 Low
干预措施: Amlodipine (Drug)
Active Comparator 2
Active Comparator
HGP0904 Low
干预措施: Placebo (Drug)
Active Comparator 3
Active Comparator
HGP0608
干预措施: Losartan (Drug)
Active Comparator 3
Active Comparator
HGP0608
干预措施: Placebo (Drug)
Placebo Comparator
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in sitting systolic blood pressure
时间窗: baseline, 8 weeks
次要结局
- Change from baseline in sitting systolic blood pressure(baseline, 4 weeks)
- Proportion of responder(baseline, 4 weeks, 8 weeks)
- Change from baseline in pulse pressure(sitSBP - sitDBP)(baseline, 4 weeks, 8 weeks)
- Proportion of subjects achieving blood pressure control(4 weeks, 8 weeks)
- Change from baseline in sitting distolic blood pressure(baseline, 4 weeks, 8 weeks)
研究者
研究点 (1)
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