NCT00147615已完成3 期
Peds II (Pediatric Eplerenone Development Study II)--An Open Label, Long-Term Study To Evaluate The Safety Of Eplerenone In The Treatment Of Hypertension In Children
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.21 个研究点 分布在 3 个国家目标入组 140 人开始时间: 2004年10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
- 140
- 试验地点
- 21
- 主要终点
- Safety of eplerenone in hypertensive children
研究概览
简要总结
To assess the long-term safety and toleration of eplerenone in the children aged 6 to 16 years with high blood pressure. The study will last at least 1 year and about 140 patients will participate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Males and females aged 6 to 16 years
- •The seated 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 4 or 5
- •Serum or whole blood potassium > 5.
结局指标
主要结局
Safety of eplerenone in hypertensive children
次要结局
- Efficacy and pharmacokinetics of eplerenone in hypertensive children
研究者
研究点 (21)
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