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

Four-week, Open-label, Multicenter, Randomized, Parallel-group Study to Investigate the Pharmacokinetics, Safety, Tolerability and the Effects on Leak Point Pressure of Two Oral Doses of Alfuzosin (0.1 mg/kg/Day; 0.2 mg/kg/Day) in Children and Adolescents 2 to 16 Years-of-age With Elevated Detrusor Leak-point Pressure of Neuropathic Etiology

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00629720

Acronym

ALFACHIP

Enrollment

Registered

2008-03-06

Start date

2006-07-31

Completion date

2007-02-28

Last updated

2009-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Bladder Neurogenic

Keywords

elevated detrusor leak point pressure

Brief summary

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.

Interventions

DRUGalfuzosin (SL770499)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

2 Years to 16 Years

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
PK parameters	—

Secondary

Measure	Time frame
Safety evaluation	—

Countries

Serbia, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026