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 - Alfahydro

INTERVENTION: Product Name: alfuzosin Product Code: SL770499‐10 Pharmaceutical Form: Oral solution INN or Proposed INN: alfuzosin CAS Number: 81403‐68‐1 Current Sponsor code: SL770499‐10 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 0.2‐ Product Name: alfuzosin Product Code: SL770499‐10 Pharmaceutical Form: Tablet INN or Proposed INN: alfuzosin CAS Number: 81403‐68‐1 Current Sponsor code: SL770499‐10 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1.5‐ CONDITION: Children with voiding dysfunction of neuropathic etiology ; MedDRA version: 9.1 Level: LLT Classification code 10047685 Term: Voiding difficulty PRIMARY OUTCOME: Main Objective: 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 LPP of neuropathic etiology. Primary end point(s): Change in grade of hydronephrosis. Secondary Objective: ‐To investigate the safety and tolerability of alfuzosin 0.2 mg/kg/day in children and; adolescents;; ‐To investigate the number of UTI episodes;; ‐To investigate the pharmacokinetics (population kinetics). INCLUSION CRITERIA: Children and adolescents of either gender 2 ‐ 16 years of age with a detrusor LPP of 40 cm water or greater and with newly diagnosed or progressive hydronephrosis grade 1 or 2 (Society of Fetal Urology) due to neuropathic bladder dysfunction. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18‐64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range