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

Pfizer

Status and phase: Completed; Phase 4

Conditions: Urinary Bladder, Overactive

Treatments: Drug: Fesoterodine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01054222

A0221090

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects must have previously completed fesoterodine study A0221045 [in Portugal]
• Subjects must be recommended for inclusion by the investigator

Exclusion criteria

• Conditions or states excluding use of fesoterodine e.g. contraindication to fesoterodine
• Predominant stress incontinence as determined by the investigator

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

31 participants in 2 patient groups

Fesoterodine 4 mg

Other group

Description:

Dose determined as per previous drug regime in A0221045 and investigator's evaluation.

Treatment:

Drug: Fesoterodine

Drug: Fesoterodine

Fesoterodine 8 mg

Other group

Description:

Dose determined as per previous drug regime in A0221045 and investigator's evaluation.

Treatment:

Drug: Fesoterodine

Drug: Fesoterodine