NCT00576823

Alfuzosin Treatment in Children and Adolescents With Hydronephrosis of Neuropathic Etiology

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 2 Years – 16 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The study consisted of 2 phases: * a 12-week efficacy phase then, * a 40-week safety extension phase. All eligible subjects received alfuzosin 0.2 mg/kg/day. The formulation and the frequency was assigned by Interactive Voice Response System (IVRS) according to age group and ability to swallow tablets. Patients who completed the 12-week open-label treatment period were offered to continue in the 40-week open-label safety extension study. The treatment was the same as in the 12-week efficacy phase. All patients had a one-week follow-up period after the last dose intake.

Conditions

• Hydronephrosis
• Neurogenic Bladder

Interventions

Type	Name	Description
DRUG	Alfuzosin	Dose: 0.2 mg/kg/day Route: oral

Timeline

• Start date: 2007-12-01
• Primary completion: 2009-01-01
• Completion: 2009-10-01
• First posted: 2007-12-19
• Last updated: 2014-10-29
• Results posted: 2011-02-08

Locations

12 sites across 12 countries: Bulgaria, Canada, Estonia, India, Malaysia, Poland, Russia, Serbia, Singapore, Slovakia, Taiwan, Turkey (Türkiye)