Who is sponsoring ALFACHIP?

ALFACHIP is sponsored by Sanofi.

What condition does ALFACHIP study?

ALFACHIP studies Urinary Bladder Neurogenic.

What drugs are being tested in ALFACHIP?

Interventions: alfuzosin (SL770499).

What is the status of ALFACHIP?

ALFACHIP is currently COMPLETED.

Last reviewed 2009-12-11 · How we verify

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 (ALFACHIP)

NCT00629720 Phase 3 COMPLETED

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.

Details

Lead sponsor	Sanofi
Phase	Phase 3
Status	COMPLETED
Enrolment	29
Start date	2006-07
Completion	2007-02

Conditions

Urinary Bladder Neurogenic

Interventions

alfuzosin (SL770499)

Primary outcomes

PK parameters

Countries

United States, Serbia