NCT02916602已完成3 期
A Randomized, Double-blind, Multicenter, Phase 3 Study to Evaluate Efficacy and Safety of HCP1401 for Stage 2 Hypertension Patients Not Controlled by HCP0605
Hanmi Pharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 340 人开始时间: 2015年4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
- 已完成
- 发起方
- 入组人数
- 340
- 试验地点
- 1
- 主要终点
- Change from baseline in sitting systolic blood pressure at week 8
研究概览
简要总结
A phase 3 study to evaluate efficacy and safety of HCP1401
详细描述
A randomized, double-blind, multicenter, phase 3 study to evaluate efficacy and safety of HCP1401 for stage 2 hypertension patients not controlled by HCP0605
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
- •Hypertension patient who satisfied below condition at Visit
- •patient who takes antihypertensive drug
- •140mmHg <= sitSBP <= 200mmHg
- •patient who doesn't take antihypertensive drug
- •160mmHg <= sitSBP <= 200mmHg
- •140mmHg <= sitSBP <= 200mmHg at Visit 2
排除标准
- •Patient who have received 4 or more antihypertensive drug
- •Patient with 20mmHg of difference in sitSBP or 10mmHg of difference in sitDBP between 3 times of BP measuring at Visit 1
- •Patient with sitDBP >= 120mmHg at Visit 2
- •Patient with secondary hypertension
研究组 & 干预措施
Treatment
Experimental
HCP1401
干预措施: HCP1401 (Drug)
Reference
Active Comparator
HCP0605
干预措施: HCP0605 (Drug)
结局指标
主要结局
Change from baseline in sitting systolic blood pressure at week 8
时间窗: 8 weeks
次要结局
- Change from baseline in sitting diastolic blood pressure at week 2 and week 8(2 weeks and 8 weeks)
- Change from baseline in sitting systolic blood pressure at week 2(2 weeks)
- Proportion of subjects achieving Blood Pressure control(2 weeks and 8 weeks)
研究者
研究点 (1)
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