NCT00779181已完成2 期
A Phase 2, Dose-Ranging Study of the Safety and Efficacy of ADX415 Immediate-Release in the Treatment of 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
- 80
- 主要终点
- Change in ABPM measures
研究概览
简要总结
The purpose of this study is to determine a safe and effective dose of ADX415 for the treatment of 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild to moderate hypertension
- •Age 18-75 years, inclusive
排除标准
- •Clinically significant illnesses or abnormalities upon evaluation
- •Current treatment with 3 or more antihypertensive meds
- •Presence of Type I or uncontrolled Type II diabetes
- •Presence of alcohol or drug abuse
研究组 & 干预措施
ADX415 (high dose)
Experimental
A high dose of ADX415
干预措施: ADX415 (Drug)
ADX415 (mid level dose)
Experimental
A mid level dose of ADX415
干预措施: ADX415 (Drug)
ADX415 (low dose)
Experimental
A low dose of ADX415
干预措施: ADX415 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in ABPM measures
时间窗: Baseline to Day 26
次要结局
- Treatment emergent adverse events, lab tests, vitals signs, and ECGs(Throughout treatment period)
研究者
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