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Long Term Study To Evaluate the Safety, Tolerability and Efficacy of Fesoterodine for Overactive Bladder.
This study has been completed.
Study NCT00658684   Information provided by Pfizer
First Received: April 9, 2008   Last Updated: September 29, 2009   History of Changes

April 9, 2008
September 29, 2009
February 2008
August 2009   (final data collection date for primary outcome measure)
To assess the long term safety, tolerability and efficacy of Fesoterodine. [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00658684 on ClinicalTrials.gov Archive Site
  • Change from baseline in mean number of micturitions, urgency urinary incontinence (UUI) episodes, incontinence episodes, urgency episodes and nighttime micturitions at Week 4, 8, 28 and 52. [ Time Frame: Weeks 4, 8, 28 and 52 ] [ Designated as safety issue: No ]
  • Change from baseline in mean voided volume per micturitions at Week 4, 8, 28 and 52. [ Time Frame: Weeks 4, 8, 28 and 52 ] [ Designated as safety issue: No ]
  • Safety measurement based on Adverse events, Vital signs, Clinical laboratory test, 12-lead ECG and Residual urine volume. [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline in score of King's Health Questionnaire (KHQ) and Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52. [ Time Frame: Weeks 28 and 52 ] [ Designated as safety issue: No ]
  • The number of subjects shifted in Patient Perception of Bladder Condition (PPBC) responses from baseline to Week 28 and 52 assessment and its percentage. [ Time Frame: Weeks 28 and 52 ] [ Designated as safety issue: No ]
  • Change from baseline in grade of PPBC at Week 28 and 52. [ Time Frame: Weeks 28 and 52 ] [ Designated as safety issue: No ]
Same as current
 
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.

 
Phase III
Interventional
Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Overactive Bladder
Drug: fesoterodine fumarate
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) 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.
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00658684
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
A0221006, A0221006
Pfizer
 
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2009

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