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A Study Of Efficacy And Safety Of Fesoterodine In Vulnerable Elderly Subjects With Overactive Bladder

Last updated on December 15, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35233 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Overactive 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

- male or female subjects 65 years of age or older

- OAB symptoms for at least 3 months

- score 3 or greater on Vulnerable Elderly Survey (VES-13)

- adequate mobility for independent toileting

- mean number of at least 2 UUI episodes per 24 hours

- mean urinary frequency of 8 or more micturitions per 24 hours

- able to independently complete the bladder diaries

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

- PVR urinary volume greater than 200 ml

- MMSE score less than 20

- greater than 15 UUI episodes per 24 hours

- creatinine clearance less than 30 ml/min

- an average resting heart rate of greater than or equal to 90 beats per minute

NCT00928070
Pfizer
Completed
A Study Of Efficacy And Safety Of Fesoterodine In Vulnerable Elderly Subjects With Overactive Bladder

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A Study Of Efficacy And Safety Of Fesoterodine In Vulnerable Elderly Subjects With Overactive Bladder
A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Trial To Evaluate The Efficacy And Safety Of Fesoterodine Flexible Dose Regimen In Vulnerable Elderly Patients With Overactive Bladder.
This study is designed to assess the efficacy and safety of a flexible dose regimen of fesoterodine on urgency urinary incontinence (UUI) episodes in vulnerable elderly subjects with overactive bladder (OAB).
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Overactive Bladder
  • Drug: Fesoterodine
    Fesoterodine 4 mg and 8 mg
  • Drug: Placebo
    Placebo sham 4 mg and 8 mg
  • Experimental: Fesoterodine
    Intervention: Drug: Fesoterodine
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
566
September 2011
September 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • male or female subjects 65 years of age or older
  • OAB symptoms for at least 3 months
  • score 3 or greater on Vulnerable Elderly Survey (VES-13)
  • adequate mobility for independent toileting
  • mean number of at least 2 UUI episodes per 24 hours
  • mean urinary frequency of 8 or more micturitions per 24 hours
  • able to independently complete the bladder diaries

Exclusion Criteria:

  • PVR urinary volume greater than 200 ml
  • MMSE score less than 20
  • greater than 15 UUI episodes per 24 hours
  • creatinine clearance less than 30 ml/min
  • an average resting heart rate of greater than or equal to 90 beats per minute
Sexes Eligible for Study: All
65 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00928070
A0221049
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2012

ICMJE     Data element required by the

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

FOR MORE INFORMATION

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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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]



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