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Open-label Long-term Extension Study of Fesoterodine in Japanese Subjects With Neurogenic Detrusor Overactivity.

Urinary Bladder, Neurogenic Clinical Trial

Official title:
LONG-TERM EXTENSION STUDY TO EVALUATE THE SAFETY OF FESOTERODINE IN JAPANESE PEDIATRIC SUBJECTS WITH SYMPTOMS OF DETRUSOR OVERACTIVITY ASSOCIATED WITH A NEUROLOGICAL CONDITION (NEUROGENIC DETRUSOR OVERACTIVITY) WHO HAVE COMPLETED 24 WEEKS TREATMENT IN STUDY A0221047

Clinical Trial Summary

The purpose of this study is to investigate the safety and tolerability of fesoterodine following once daily long-term treatment in Japanese pediatric neurogenic detrusor overactivity (NDO) subjects.

Clinical Trial Description

This is a Phase 3, multi-center, open-label long-term extension study in Japanese NDO subjects who participated and completed in the precedent Study A0221047 which is a 24 weeks, randomized, open label study, to investigate the safety and tolerability of fesoterodine. This study consists of a 28-week open-label treatment period followed by a 4-week follow-up. In addition, subjects in the oxybutynin arm of the precedent Study A0221047 will continue the fesoterodine treatment until Week 40 visit in this study, in order to obtain fesoterodine 1 year treatment data. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02501928
Study type Interventional
Source Pfizer
Contact
Status Completed
Phase Phase 3
Start date June 5, 2015
Completion date April 1, 2020
View Details
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