| 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 |
| |
| |
| |
| 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 |