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Long Term Study To Evaluate the Safety, Tolerability and Efficacy of Fesoterodine for Overactive Bladder.

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NCT00658684

Last updated on October 4, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Inegeku, Chibashi, Chiba-ken, Japan
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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
20+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Adult OAB patients who present with OAB symptoms, including micturitions >= 8 per day
and urinary urgency episodes >=1 per day.

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

- Patient has known hypersensitivity to the active substance (fesoterodine fumarate) or
to peanut or soya or any of the excipients.

- Patient has a known neurological disease influencing bladder function.

- Patient has a complication of lower urinary tract pathology potentially responsible
for urgency or incontinence, clinically relevant bladder outlet obstruction or pelvic
organ prolapse.

NCT00658684
Pfizer
Completed
Long Term Study To Evaluate the Safety, Tolerability and Efficacy of Fesoterodine for Overactive Bladder.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Long Term Study To Evaluate the Safety, Tolerability and Efficacy of Fesoterodine for Overactive Bladder.
An Open-Label, Multicenter, Long Term Study to Evaluate the Safety, Tolerability and Efficacy of Fesoterodine in Patients With Overactive Bladder.
To assess the long term safety, tolerability and efficacy of fesoterodine in patients with OAB.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Overactive Bladder
Drug: fesoterodine fumarate
4 mg tablets OD for 4 weeks, then either 4 mg or 8 mg tablets OD for 48 weeks
Experimental: Fesoterodine fumarate
Intervention: Drug: fesoterodine fumarate
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
153
August 2009
August 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult OAB patients who present with OAB symptoms, including micturitions >= 8 per day and urinary urgency episodes >=1 per day.

Exclusion Criteria:

  • Patient has known hypersensitivity to the active substance (fesoterodine fumarate) or to peanut or soya or any of the excipients.
  • Patient has a known neurological disease influencing bladder function.
  • Patient has a complication of lower urinary tract pathology potentially responsible for urgency or incontinence, clinically relevant bladder outlet obstruction or pelvic organ prolapse.
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00658684
A0221006
A0221006
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2010

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.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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