12-week, multicenter, open-label, non-comparative study to investigatepharmacodynamic and safety of alfuzosin 0.2 mg/kg/day in the treatment of childrenand adolescents 2 - 16 years of age with hydronephrosis associated with elevateddetrusor leak point pressure of neuropathic etiology followed by a 40-week open-label extension----------------------------------------------------------------------------------------------------------Estudio multicéntrico, abierto, no comparativo de 12 semanas de duración para investigar la farmacodinámica y seguridad de alfuzosina 0,2 mg/kg/día en el tratamiento de niños y adolescentes de 2 –16 años de edad con hidronefrosis asociada con elevación de la presión de pérdida del detrusor de etiología neuropática, seguido por una fase de extensión abierta de 40 semanas de duración.” - Alfahydro

• Conditions: Children with voiding dysfunction of neuropathic etiology------------------------------------------------------------------------Niños con disfunción en la micción de etiología neuropática; MedDRA version: 9.1Level: LLTClassification code 10047685Term: Voiding difficulty

• Registration Number: EUCTR2007-000983-26-ES
• Lead Sponsor: sanofi-aventis recherche et développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-21
• Last Update Posted: 28 August 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

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

Exclusion Criteria

-Hydronephrosis of non-neuropathic etiology
-Patients who had an urological surgery within the last 4 months prior to the study
-Patients who have undergone urethral dilatation within the last 3 months prior to the study
-Patients who have received a-blocker therapy within the last 4 weeks prior to the study
-Patients who have received any detrusor injections of botulinum toxin in the last six months
-Patients with urological diseases/conditions other than functional bladder obstruction of neuropathic etiology that can lead to upper tract dilatation (e.g., bladder anomalies, ureterocele)
-Patients with a history of severe respiratory, cardiovascular, gastrointestinal, metabolic, hepatic, neurologic, endocrine, or renal disease or other serious disorders, which would interfere with the interpretation of the study results (e.g.high grade of vesicoureteral reflux)
-Patients or parents/legally authorized representatives who are illiterate or are judged to be unable to understand the nature, scope and possible consequences of the study
-History of known intolerance to a-blocker therapy
-History of risk factors for Torsade de pointes (e.g., family history of Long QT Syndrome)
-QTcF > 450 msec at screening electrocardiogram
-History of unexplained loss of consciousness
-Orthostatic hypotension
-Patients who have taken potent cytochrome P450-3A4 inhibitors in the last 4 weeks prior to the study
-Pregnant or breast-feeding females and females of childbearing potential not protected by effective contraceptive methods of birth control.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine efficacy of alfuzosin in the treatment of children and adolescents 2 -<br>16 years of age with newly diagnosed or progressive hydronephrosis due to elevated detrusor LPP of neuropathic etiology.;Secondary Objective: -To investigate the safety and tolerability of alfuzosin 0.2 mg/kg/day in children and<br>adolescents;<br>-To investigate the number of UTI episodes;<br>-To investigate the pharmacokinetics (population kinetics).;Primary end point(s): Change in grade of hydronephrosis.