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临床试验/NCT00629720
NCT00629720已完成3 期

Four-week, Open-label, Multicenter, Randomized, Parallel-group Study to Investigate the Pharmacokinetics, Safety, Tolerability and the Effects on Leak Point Pressure of Two Oral Doses of Alfuzosin (0.1 mg/kg/Day; 0.2 mg/kg/Day) in Children and Adolescents 2 to 16 Years-of-age With Elevated Detrusor Leak-point Pressure of Neuropathic Etiology

Sanofi2 个研究点 分布在 2 个国家目标入组 29 人开始时间: 2006年7月最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
Sanofi
入组人数
29
试验地点
2
主要终点
PK parameters

研究概览

简要总结

The primary objective is to investigate the pharmacokinetics (PK) of 2 doses of alfuzosin (given as a solution or tablets depending on age) in children and adolescents 2 to 16 years of age with elevated detrusor Leak Point Pressure (LPP) (≥40 cm H2O) of neuropathic etiology stratified into 2 age groups (2 to 7 years and 8 to 16 years).

The secondary objectives are to investigate the safety and tolerability of the 2 dose regimens and to determine the effect of the 2 dose regimens on detrusor LPP.

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
None

入排标准

年龄范围
2 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children and adolescents of either gender 2-16 years of age with elevated detrusor LPP of neuropathic etiology.

排除标准

  • 未提供

结局指标

主要结局

PK parameters

次要结局

  • Safety evaluation

研究者

发起方
Sanofi
申办方类型
Industry

研究点 (2)

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