NCT00147589已完成3 期
Peds I (Pediatric Eplerenone Development Study I): A Randomized, Double-Blind, Placebo Withdrawal, Parallel Group, Dose-Response Study To Evaluate The Efficacy And Safety Of Eplerenone In The Treatment Of Hypertension In Children
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.41 个研究点 分布在 5 个国家目标入组 320 人开始时间: 2004年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 320
- 试验地点
- 41
- 主要终点
- Efficacy of eplerenone in children
研究概览
简要总结
To evaluate the efficacy, safety, and toleration of eplerenone in the treatment of children aged 6 to 16 years with high blood pressure. The study will last approximately 10 weeks and about 320 patients will participate.
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
入排标准
- 年龄范围
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •6-16 years old male and female
- •Systolic blood pressure greater than or equal to the 95th percentile for age, gender, and height, measured on at least 3 separate occasions
排除标准
- •K/DOQI classification of stages of chronic kidney disease equal to or greater than 3
- •Serum or whole blood potassium > 5.5 mEq/L
结局指标
主要结局
Efficacy of eplerenone in children
次要结局
- Safety and tolerability of eplerenone in hypertensive children
研究者
研究点 (41)
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