Overview

Alfuzosin Treatment in Children and Adolescents With Hydronephrosis of Neuropathic Etiology

Status:
Completed
Trial end date:
2009-10-01
Target enrollment:
Participant gender:
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).
Phase:
Phase 3
Details
Lead Sponsor:
Sanofi
Treatments:
Alfuzosin
Pharmaceutical Solutions