NCT01054222

Local, Open-Label, Extension Trial Of The Efficacy And Safety Of Fesoterodine In Elderly Patients With Overactive Bladder

A Local, Multicentre, Open-Label, Extension Trial To Evaluate The Efficacy And Safety Of Fesoterodine Flexible Dose Regimen In Elderly Patients With Overactive Bladder

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urinary Bladder, Overactive

Interventions

Type	Name	Description
DRUG	Fesoterodine	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)
DRUG	Fesoterodine	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)

Timeline

• Start date: 2010-05-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2010-01-22
• Last updated: 2013-05-15
• Results posted: 2013-05-15

Locations

3 sites across 1 country: Portugal