NCT04218552已完成2 期
A Randomized, Double-Blind, Parallel, Multi-Center, Phase 2 Clinical Trial to Determine the Optimal Dose of AD-209 in Patients With Essential Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- 1. Change rate of MSSBP
研究概览
简要总结
The purpose of this study is to determine the optimal dose of AD-209 in patients with Essential Hypertension.
详细描述
Condition or disease : hypertension Intervention/treatment Drug : AD-209-H Drug : AD-209-M Drug : AD-209-L Drug : Placebo Drug : Amlodipine Drug : Telmisartan 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
Active Comparator 1
Active Comparator
Amlodipine Low
干预措施: Amlodipine low (Drug)
Experimental 1
Experimental
AD-209 High
干预措施: AD209 (Drug)
Experimental 2
Experimental
AD-209 Middle
干预措施: AD209 (Drug)
Experimental 3
Experimental
AD-209 Low
干预措施: AD209 (Drug)
Active Comparator 2
Active Comparator
Amlodipine High
干预措施: Amlodipine high (Drug)
Active Comparator 3
Active Comparator
Telmisartan
干预措施: Telmisartan (Drug)
Placebo comparator
Placebo Comparator
Placebo
干预措施: AD209 (Drug)
Placebo comparator
Placebo Comparator
Placebo
干预措施: Amlodipine low (Drug)
Placebo comparator
Placebo Comparator
Placebo
干预措施: Amlodipine high (Drug)
Placebo comparator
Placebo Comparator
Placebo
干预措施: Telmisartan (Drug)
结局指标
主要结局
1. Change rate of MSSBP
时间窗: [ Time Frame: baseline, 8 weeks ]
Change from baseline in mean sitting systolic blood pressure
次要结局
- 1. Change rate of MSSBP([ Time Frame: baseline, 4 weeks ])
- 2. Change rate of MSDBP([ Time Frame: baseline, 4 weeks, 8 weeks ])
- 4.Reaction rate of BP([ Time Frame: baseline, 4 weeks, 8 weeks ])
- 3. Proportion of BP normalization MSSBP/MSDBP < 140/90 mmHg MSSBP/MSDBP < 130/80 mmHg (Diabetes or Chronic renal disease)([ Time Frame: 4 weeks, 8 weeks ])
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
A Study to Evaluate the Efficacy and Safety of AD-209Hypertension, EssentialNCT05631990Addpharma Inc.221
招募中
3 期
Phase III Study to Evaluate the Efficacy and Safety of AD-209Hypertension,EssentialNCT06348576Addpharma Inc.280
已完成
2 期
Therapeutic Efficacy of APD-209 Eye Drops in Treatment of Epidemic Keratoconjunctivitis (EKC)Viral ConjunctivitisNCT01977443Adenovir Pharma AB47
已完成
1 期
A Study to Compare Pharmacokinetic Parameters and Safety Profiles Between AD-109 and AD-1091Embolism and ThrombosisNCT05128591Addpharma Inc.38
已完成
2 期
A Study to Assess the Safety and Efficacy of Different AD 237 Doses in Adults With COPDCOPDNCT00242333Sosei300