drugset / Trial / NCT00576823

Alfuzosin Treatment in Children and Adolescents With Hydronephrosis of Neuropathic Etiology

NCT00576823

Phase 3 Completed 25 enrolled Sanofi
Non-randomizedParallel-groupOpen-labelTreatment

Summary

Primary objective was to determine efficacy of Alfuzosin in the treatment of children and adolescents 2-16 years of age with newly diagnosed or progressive hydronephrosis due to elevated detrusor Leak Point Pressure \[LPP\] of neuropathic etiology. Secondary objectives were: * To investigate the safety and tolerability of alfuzosin 0.2 mg/kg/day in children and adolescents, * To investigate the number of Urinary Tract Infection (UTI) episodes, * To investigate the pharmacokinetics of Alfuzosin (population kinetics).

Timeline

Start
2007-12
Primary completion
2009-01
Completion
2009-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Alfuzosin Small molecule 0.2 mg/kg Oral

Indications