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

Last updated on May 9, 2018

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Study Location
Centro de Avaliação Geriátrica
Lisboa, , 1990-273 Portugal
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Overactive Urinary Bladder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
65+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subjects must have previously completed fesoterodine study A0221045 [in Portugal]

- Subjects must be recommended for inclusion by the investigator

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Conditions or states excluding use of fesoterodine e.g. contraindication to
fesoterodine

- Predominant stress incontinence as determined by the investigator

NCT01054222
Pfizer
Completed
Local, Open-Label, Extension Trial Of The Efficacy And Safety Of Fesoterodine In Elderly Patients With Overactive Bladder

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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
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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Urinary Bladder, Overactive
  • 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)
    Other Name: Toviaz
  • 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)
    Other Name: Toviaz
  • Fesoterodine 4 mg
    Dose determined as per previous drug regime in A0221045 and investigator's evaluation.
    Intervention: Drug: Fesoterodine
  • Fesoterodine 8 mg
    Dose determined as per previous drug regime in A0221045 and investigator's evaluation.
    Intervention: Drug: Fesoterodine
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
January 2012
January 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
65 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Portugal
 
 
NCT01054222
A0221090
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021



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