NCT02244528已完成2 期
Pharmacokinetic Study of Sildenafil in Neonates and Preterm Infants
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
- 20
- 试验地点
- 2
- 主要终点
- AUC(0-t)
研究概览
简要总结
The purpose of this study is to investigate the pharmacokinetics of sildenafil which is used as treatment of pulmonary hypertension in neonate and preterm infant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admitted at NICU in Seoul National University Hospital or Bundang Seoul National University hospital
- •Infants who were diagnosed with PAH
排除标准
- •Severe allergic reaction to sildenafil
- •Inotropics for hypotension within 3 days prior to enrollment
- •AST or ALT > 3x ULN
- •Any condition that would make the participant, in the opinion of the investigator, unsuitable for the stud
研究组 & 干预措施
Treatment
Experimental
sildenafil treatment
干预措施: Sildenafil (Drug)
结局指标
主要结局
AUC(0-t)
时间窗: t up to 5 weeks
5 times drug level after 5 doses (pre30min/post 30min, 1hr, 2hr, 4hr) pharmacokinetics
Cmax(0-t)
时间窗: t up to 5 weeks
5 times drug level after 5 doses (pre30min/post 30min, 1hr, 2hr, 4hr) pharmacokinetics
次要结局
- Change from baseline in pulmonary arterial hypertension at 5 weeks(pre, 2 weeks, 5 weeks of drug administration)
- respiratory severity score(pre, 2 weeks, 5 weeks after administration)
研究者
Han-Suk Kim
Professor
Seoul National University Hospital
研究点 (2)
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