A Multicenter, Randomized, Double-blind, Active-control, Phase III Study to Evaluate the Efficacy and Safety of AD-223A and AD-223B Combination Therapy in Patients With Essential Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 502
- 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-223
详细描述
Condition or disease : 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
- •Signed informed consent
- •Other inclusions applied
排除标准
- •Orthostatic hypotension with symptom
- •Other exclusions applied
研究组 & 干预措施
Control group 1
AD-223A+AD-223B Placebo+AD-223C Placebo
干预措施: AD-223A (Drug)
Test group
AD-223A+AD-223B+AD-223C Placebo
干预措施: AD-223A (Drug)
Test group
AD-223A+AD-223B+AD-223C Placebo
干预措施: AD-223B (Drug)
Test group
AD-223A+AD-223B+AD-223C Placebo
干预措施: AD-223C Placebo (Drug)
Control group 1
AD-223A+AD-223B Placebo+AD-223C Placebo
干预措施: AD-223B Placebo (Drug)
Control group 1
AD-223A+AD-223B Placebo+AD-223C Placebo
干预措施: AD-223C Placebo (Drug)
Control group 3
AD-223A Placebo+AD-223B Placebo+AD-223C
干预措施: AD-223B Placebo (Drug)
Control group 2
AD-223A Placebo+AD-223B+AD-223C Placebo
干预措施: AD-223B (Drug)
Control group 2
AD-223A Placebo+AD-223B+AD-223C Placebo
干预措施: AD-223A Placebo (Drug)
Control group 2
AD-223A Placebo+AD-223B+AD-223C Placebo
干预措施: AD-223C Placebo (Drug)
Control group 3
AD-223A Placebo+AD-223B Placebo+AD-223C
干预措施: AD-223C (Drug)
Control group 3
AD-223A Placebo+AD-223B Placebo+AD-223C
干预措施: AD-223A 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