NCT05463614招募中不适用
Population Pharmacokinetics of Propafenone and Propranolol in Children Patients
Shandong University1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2019年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Ventricular premature beats of 24 hours
研究概览
简要总结
The use of propafenone and propranolol in children during clinical treatment was depending mostly on experience. Besides, there was no recommended dose for children in drug instruction. Therefore, the investigators' aim is to study the pharmacokinetics and pharmacodynamics in children.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≤18years. Parental written consent to participate in the study. Patients treat with Propafenone and Propranolol
排除标准
- •Patients can not complete the research; Abnormal hepatic and renal function; Patient is allergic to propafenone; There are conditions that researchers do not consider it appropriate to join the research.
结局指标
主要结局
Ventricular premature beats of 24 hours
时间窗: From date of randomization until the date of discharge, assessed up to 12 months
frequency of Ventricular premature beats of 24 hours
次要结局
- P-R interval(From date of randomization until the date of discharge, assessed up to 12 months)
- QT interval(From date of randomization until the date of discharge, assessed up to 12 months)
研究者
Wei Zhao
professor
Shandong University
研究点 (1)
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