Neurogenic Bladder Clinical Trial
Official title:
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
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).
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.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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