Alfuzosin Treatment in Children and Adolescents With Hydronephrosis of Neuropathic Etiology

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Alfuzosin; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Children and adolescents of either gender 2 - 16 years of age with a detrusor Leak Point Pressure (LPP) of 40 cm water or greater and with newly diagnosed or progressive hydronephrosis either Society of Fetal Urology (SFU) grade 1, 2 or 3 due to neuropathic bladder dysfunction.

Exclusion Criteria:

• Hydronephrosis of non-neuropathic etiology.

• Urological surgery in the last 4 months prior to the study.

• Urethral dilatation in the last 3 months prior to the baseline urodynamic assessment.

• α-blocker therapy in the last 4 weeks prior to the baseline urodynamic assessment.

• Detrusor injections of botulinum toxin in the last 6 months.

• Urological diseases/conditions other than functional bladder obstruction of neuropathic etiology, that can lead to upper urinary tract dilatation (e.g., bladder anomalies, ureterocele).

• History of intolerance to α-blocker therapy.

• Orthostatic hypotension.

• History of risk factors for Torsade de pointes (e.g., family history of Long QT Syndrome).

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.