At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
12-week, Multicenter, Open-label, Non-comparative Study to Investigate Pharmacodynamic and Safety of Alfuzosin 0.2 mg/kg/Day in the Treatment of Children and Adolescents 2 - 16 Years of Age With Hydronephrosis Associated With Elevated Detrusor Leak Point Pressure of Neuropathic Etiology Followed by a 40-week Open-label Extension
In Brief
A Phase 3 clinical trial evaluating Alfuzosin for Hydronephrosis and Neurogenic Bladder. Completed, enrolled 25 participants across 12 sites in 12 countries.
Detailed 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).
Study Details
Timeline
Interventions
Dose: 0.2 mg/kg/day Route: oral