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Alfuzosin Treatment in Children and Adolescents With Hydronephrosis of Neuropathic Etiology

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hydronephrosis; Neurogenic Bladder

Intervention: Alfuzosin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
ICD CSD, Study Director, Affiliation: Sanofi

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).

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of Participants With a Decrease From Baseline ≥ 1 in the Society of Fetal Urology (SFU) Grade of Hydronephrosis

Secondary outcome:

Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes

Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes

Detailed description: 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.

Eligibility

Minimum age: 2 Years. Maximum age: 16 Years. Gender(s): Both.

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.

Locations and Contacts

Sanofi-Aventis Administrative Office, Sofia, Bulgaria

Sanofi-Aventis Administrative Office, Laval, Canada

Sanofi-Aventis Administrative Office, Tallin, Estonia

Sanofi-Aventis Administrative Office, Mumbai, India

Sanofi-Aventis Administrative Office, Kuala Lumpur, Malaysia

Sanofi-Aventis Administrative Office, Warszawa, Poland

Sanofi-Aventis Administrative Office, Moscow, Russian Federation

Sanofi-Aventis Administrative Office, Belgrade, Serbia

Sanofi-Aventis Aministrative Office, Singapore, Singapore

Sanofi-Aventis Administrative Office, Bratislava, Slovakia

Sanofi-Aventis Administrative Office, Taipei, Taiwan

Sanofi-Aventis Administrative Office, Istanbul, Turkey

Additional Information

Starting date: December 2007
Last updated: October 21, 2014

Page last updated: August 23, 2015

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