| January 28, 2008 |
| November 23, 2009 |
| February 2008 |
| October 2009 (final data collection date for primary outcome measure) |
| To compare the efficacy of fesoterodine with that of placebo and of tolterodine ER in subjects with overactive bladder [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00611026 on ClinicalTrials.gov Archive Site |
- To compare the effect of fesoterodine with that of placebo on patient reported outcomes in subjects with overactive bladder [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- To compare the efficacy of fesoterodine 4 mg QD with that of placebo in subjects with overactive bladder [ Time Frame: 1 week ] [ Designated as safety issue: No ]
- To summarize safety data for fesoterodine, tolterodine ER, and placebo in subjects with overactive bladder [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
|
| Same as current |
| |
| Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine ER in Patients With Overactive Bladder. |
| 12-Week, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group, Multicenter Trial To Evaluate The Efficacy And Safety Of Fesoterodine In Comparison To Tolterodine ER In Patients With Overactive Bladder. |
To evaluate the efficacy and safety of fesoterodine in comparison to tolterodine and placebo for overactive bladder |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study |
| Overactive Bladder |
- Drug: Tolterodine ER
- Drug: Placebo
- Drug: Fesoterodine
|
| |
| |
| |
| Completed |
| 2160 |
| October 2009 |
| October 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Adult subjects with overactive bladder symptoms (subject-reported) for greater than or equal to 3 months prior to Screening/Enrollment visit.
- Reported at least an average of 1 UUI episode per 24 hours in the 3-day bladder diary prior to the Randomization/Baseline visit
- Mean urinary frequency of greater than or equal to 8 micturitions per 24 hours as verified by the 3-day bladder diary prior to randomization/Baseline visit.
Exclusion Criteria:
- Subjects with any condition that would contraindicate their usage of fesoterodine including: hypersensitivity to the active substance (fesoterodine fumarate) or to peanut or soya or any of the excipients, urinary retention, gastric retention, uncontrolled narrow angle glaucoma, myasthenia gravis, severe hepatic impairment (Child Pugh C), severe ulcerative colitis, and toxic megacolon.
- Subjects with clinically significant hepatic or renal disease or other significant unstable diseases.
- OAB symptoms caused by neurological conditions, known pathologies of urinary tract, etc.
- Subjects with previous history of acute urinary retention requiring catheterization, or severe voiding difficulties in the judgment of the investigator, prior to baseline.
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| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Brazil, Bulgaria, Canada, Colombia, Costa Rica, Estonia, Germany, Greece, Hungary, India, Ireland, Korea, Republic of, Latvia, Lithuania, Malaysia, Poland, Romania, Russian Federation, Singapore, Slovakia, South Africa, Spain, Sweden, Ukraine |
| |
| NCT00611026 |
| Director, Clinical Trial Disclosure Group, Pfizer Inc |
| A0221046 |
| Pfizer |
|
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
|
| Pfizer |
| November 2009 |