Urinary Bladder Neurogenic Clinical Trial
Official title:
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment