Conditions: Urinary Bladder, Overactive
Keywords: overactive bladder idiopathic elderly fesoterodine SOFIA Portugal extension study
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 31
Healthy volunteers: no

Brief summary:
This is an open-label extension study intended for subjects who have previously completed study A0221045 (fesoterodine in elderly OAB patients) and who have been recommended by the investigator as being suitable for the extended use of Fesoterodine. Data from this study will extend the evaluation of efficacy, tolerability and safety of Fesoterodine in older subjects from Portugal.

Detailed description:

Arms:
arm 1: Dose determined as per previous drug regime in A0221045 and investigator's evaluation. arm 2: Dose determined as per previous drug regime in A0221045 and investigator's evaluation.

Interventions: intervention 1: Fesoterodine intervention 2: Fesoterodine
Intervention descriptions: intervention 1: Fesoterodine fumarate, sustained release (SR) tablet, 4 mg once daily, oral, duration - until fesoterodine is commercially available in Portugal or until 31 Dec 2011 (whichever is earlier) intervention 2: Fesoterodine fumarate, sustained release (SR) tablet, 8 mg once daily, oral, duration - until fesoterodine is commercially available in Portugal or until 31 Dec 2011 (whichever is earlier)

Protocol document: