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

Sanofi

Status and phase: Completed; Phase 3

Conditions: Urinary Bladder Neurogenic

Treatments: Drug: alfuzosin (SL770499)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00629720

PKM6270

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Ages: 2 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)