A Randomized, Double-Blind, Parallel, Multi-Center, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of AD-209 in Patients With Essential Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 221
- 试验地点
- 1
- 主要终点
- Change rate of MSSBP
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of AD-209
详细描述
Condition or disease : hypertension Intervention/treatment Drug : AD-209 Drug : AD-209-1A Drug : AD-209-1B Drug : AD-209-1C Drug : AD-209 Placebo Drug : AD-209-1 Placebo Phase : Phase 2
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 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Other inclusions applied
排除标准
- •orthostatic hypotension with symptom
- •Other exclusions applied
研究组 & 干预措施
Experimental 1
AD-209, AD-209-1 placebo
干预措施: AD-209 (Drug)
Experimental 1
AD-209, AD-209-1 placebo
干预措施: AD-209-1 placebo (Drug)
Experimental 2
AD-209-1A, AD-209 placebo
干预措施: AD-209-1A (Drug)
Experimental 2
AD-209-1A, AD-209 placebo
干预措施: AD-209 placebo (Drug)
Experimental 3
AD-209-1B, AD-209 placebo
干预措施: AD-209-1B (Drug)
Experimental 3
AD-209-1B, AD-209 placebo
干预措施: AD-209 placebo (Drug)
Experimental 4
AD-209-1C, AD-209 placebo
干预措施: AD-209-1C (Drug)
Experimental 4
AD-209-1C, AD-209 placebo
干预措施: AD-209 placebo (Drug)
结局指标
主要结局
Change rate of MSSBP
时间窗: Baseline, Week 8
Change from baseline in mean sitting systolic blood pressure
次要结局
未报告次要终点