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Alfuzosin · ALFACHIN

Alfuzosin Treatment in Children and Adolescents With Neurogenic Urinary Bladder Dysfunction

Ensayo de Sanofi en Neurogenic Urinary Bladder (del registro, en inglés).

Fase

Fase 3

Estado

Completado

Participantes

172

previstos

Centros

18

Fin del objetivo primario

mar 2009

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en oct 2007.

Qué mide

Number of Patients With Detrusor Leak Point Pressure (LPP) < 40 cm H2O (12 weeks (double blind treatment period)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe primary objective of the study was to evaluate the efficacy of Alfuzosin in comparison to Placebo on the detrusor Leak Point Pressure (LPP) in children and adolescents 2-16 years of age with elevated detrusor LPP of neuropathic etiology and detrusor LPP ≥ 40 cm H2O. Secondary objectives were: * To investigate the safety and tolerability of two doses of Alfuzosin in comparison to Placebo in children and adolescents, * To evaluate the effects of the two doses of Alfuzosin in comparison to Placebo on: * Detrusor compliance, * Urinary tract infection, * To investigate the pharmacokinetics of Alfuzosin (population kinetics), * To evaluate the 12-month long-term safety of Alfuzosin 0.1 mg/kg/day and 0.2 mg/kg/day. The study consisted of 2 periods: * a 12-week double blind treatment period where patients were to receive either Alfuzosin 0.1 mg/kg/day or Alfuzosin 0.2 mg/kg/day or placebo then, * a 40-week open label extension treatment period where patients were to receive either Alfuzosin 0.1 mg/kg/day or Alfuzosin 0.2 mg/kg/day.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00549939), actualizada en oct 2014.