CLINICAL TRIALS PROFILE FOR FESOTERODINE FUMARATE
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All Clinical Trials for FESOTERODINE FUMARATE
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00138723 ↗ | Trial to Investigate the Efficacy, Tolerability and Safety of Fesoterodine Sustained Release in Subjects With Overactive Bladder Syndrome | Completed | Pfizer | Phase 3 | 2003-10-01 | This Phase 3 trial will investigate the efficacy, tolerability and safety of fesoterodine fumarate (SR) (fesoterodine; SPM 907) in adult male and female subjects with overactive bladder syndrome. The trial is a randomized, double-blind placebo controlled multicenter trial. The trial consisted of a 2 week Run-In period, 12 week double-blind Treatment period and 2 week Safety Follow-Up period. Subjects were randomized to one of 3 treatment arms receiving either fesoterodine fumarate 4mg, fesoterodine fumarate 8mg, or placebo during the double-blind Treatment period. Two primary efficacy variables will be assessed for submission in the United States: change in the average number of micturitions (frequency) per 24 hours and the change in the average number of urge incontinence episodes per 24 hours. For the submissions in the European Union, the first primary variable will be the change in the average number of micturitions (frequency) per 24 hours and the co-primary variable is the treatment response, based on a treatment benefit scale. All continuous variables will be measured as changes from baseline to value after 12 weeks of treatment. The following safety variables were observed and assessed: adverse events, change in residual urinary volume (mL), change in laboratory parameters, change in vital signs, change in electrocardiogram (ECG), change in physical examination and change in urological/urogynecological examination. |
| NCT00425100 ↗ | A Clinical Trial To Assess Fesoterodine On Treatment Satisfaction And Symptom Improvement In Overactive Bladder Patients | Completed | Pfizer | Phase 3 | 2007-01-01 | To evaluate the effect of fesoterodine on patient satisfaction and overactive bladder (OAB) symptom relief in OAB patients who were dissatisfied with their prior therapy with tolterodine. |
| NCT00444925 ↗ | Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine for Overactive Bladder (OAB) | Completed | Pfizer | Phase 3 | 2007-04-01 | To evaluate the efficacy and safety of fesoterodine in comparison to tolterodine and placebo for overactive bladder |
| NCT00561951 ↗ | Dose-Finding Study To Evaluate The Efficacy, Tolerability And Safety Of Fesoterodine In Comparison To Placebo For Overactive Bladder. | Completed | Pfizer | Phase 2 | 2007-11-01 | To evaluate the efficacy and safety of fesoterodine in comparison to placebo for overactive bladder. |
| NCT00658684 ↗ | Long Term Study To Evaluate the Safety, Tolerability and Efficacy of Fesoterodine for Overactive Bladder. | Completed | Pfizer | Phase 3 | 2008-02-01 | To assess the long term safety, tolerability and efficacy of fesoterodine in patients with OAB. |
| NCT00798434 ↗ | A Study to Compare the Effectiveness and Safety of Fesoterodine and Placebo in an Elderly Population of Patients Who go to the Toilet Very Frequently Due to Overactive Bladder. | Completed | Pfizer | Phase 4 | 2008-06-01 | The drug being studied, fesoterodine fumarate helps prevent the bladder neck opening at unwanted times and has been shown to help patients with overactive bladder syndrome pass urine less frequently than before treatment. It is postulated that this drug will also prove effective in elderly patients (aged > 65 years) and that the ability to change dose between 4 and 8mg will allow each patient to have an optimised treatment. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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