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

NCT01054222

Last updated date
Study Location
Centro de Avaliação Geriátrica
Lisboa, , 1990-273, Portugal
Contact
1-800-718-1021

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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

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  48. Stockholm,
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  50. Ankara,
  51. Istanbul,
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  55. Leytonstone, London
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Advanced Information
Descriptive Information
Brief Title  ICMJE Local, Open-Label, Extension Trial Of The Efficacy And Safety Of Fesoterodine In Elderly Patients With Overactive Bladder
Official Title  ICMJE A Local, Multicentre, Open-Label, Extension Trial To Evaluate The Efficacy And Safety Of Fesoterodine Flexible Dose Regimen In Elderly Patients With Overactive Bladder
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Urinary Bladder, Overactive
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 23, 2012)
31
Original Estimated Enrollment  ICMJE
 (submitted: January 20, 2010)
26
Actual Study Completion Date  ICMJE January 2012
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Portugal
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01054222
Other Study ID Numbers  ICMJE A0221090
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP