NCT04686643Unknown3 期
A Multicenter, Randomized, Double-blind, Phase III Study to Evaluate the Efficacy and Safety of AGSAVI in Patients With Essential Hypertension Inadequately Controlled With AGLS
Ahn-Gook Pharmaceuticals Co.,Ltd0 个研究点目标入组 306 人开始时间: 2021年2月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 306
- 主要终点
- Change from baseline in sitSBP at week 10
研究概览
简要总结
A phase 3 study to evaluate efficacy and safety of AGSAVI
详细描述
A randomized, double-blind, multicenter, phase 3 study to evaluate efficacy and safety of AGSAVI for Inadequately Controlled with AGLS
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
- •Hypertension patient who satisfied below condition at Visit
- •140mmHg <= sitSBP <= 200mmHg at Visit 2
- •130mmHg <= sitSBP <= 200mmHg at Visit 2(In high-risk patients)
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 2 times of BP measuring at Visit 1
- •Patient with sitDBP >= 120mmHg at Visit 1 or 2
- •Patient with secondary hypertension
研究组 & 干预措施
Reference
Active Comparator
AGLS
干预措施: AGLS (Drug)
Treatment
Experimental
AGSAVI
干预措施: AGSAVI (Drug)
结局指标
主要结局
Change from baseline in sitSBP at week 10
时间窗: 10 weeks
次要结局
- Change from baseline in sitting diastolic blood pressure at week 4 and week 10(week 4 and week 10)
- Change from baseline in sitting systolic blood pressure at week 4(week 4)
- •Proportion of subjects achieving Blood Pressure control(week 4 and week 10)
研究者
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