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 - Alfahydro

• Conditions: Children with voiding dysfunction of neuropathic etiology; MedDRA version: 9.1Level: LLTClassification code 10047685Term: Voiding difficulty

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-04
• Last Update Posted: 19 March 2012

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
-Patients with a history of grade 5 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.