Pharmacokinetics and Safety Study With Alfuzosin in Children and Adolescents With Elevated Detrusor Leak Point Pressure of Neuropathic Etiology

Completed · Phase 3

Conditions studied: Urinary Bladder Neurogenic

In brief

The primary objective is to investigate the pharmacokinetics (PK) of 2 doses of alfuzosin (given as a solution or tablets depending on age) in children and adolescents 2 to 16 years of age with elevated detrusor Leak Point Pressure (LPP) (≥40 cm H2O) of neuropathic etiology stratified into 2 age groups (2 to 7 years and 8 to 16 years). The secondary objectives are to investigate the safety and tolerability of the 2 dose regimens and to determine the effect of the 2 dose regimens on detrusor LPP.

Key facts

Study ID

NCT00629720

Run by

Sanofi

People needed

29

Starts

2006-07-01

Expected to finish

2007-02-01

Last updated by the study team

2009-12-15

Who can join

Age: 2 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children and adolescents of either gender 2-16 years of age with elevated detrusor LPP of neuropathic etiology.

Where it is running

• Sanofi-Aventis Administrative Office — Malvern, Pennsylvania, United States
• Sanofi-Aventis Administrative Office — Belgrade, Serbia

Full record on ClinicalTrials.gov

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