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Generated: December 12, 2018

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CLINICAL TRIALS PROFILE FOR FESOTERODINE FUMARATE

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Clinical Trials for Fesoterodine Fumarate

Trial ID Title Status Sponsor Phase Summary
NCT00138723 Trial to Investigate the Efficacy, Tolerability and Safety of Fesoterodine Sustained Release in Subjects With Overactive Bladder Syndrome Completed Pfizer Phase 3 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 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 To evaluate the efficacy and safety of fesoterodine in comparison to tolterodine and placebo for overactive bladder
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Fesoterodine Fumarate

Condition Name

Condition Name for Fesoterodine Fumarate
Intervention Trials
Overactive Bladder 6
Urinary Bladder, Overactive 2
Urge Urinary Incontinence 1
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Condition MeSH

Condition MeSH for Fesoterodine Fumarate
Intervention Trials
Urinary Bladder, Overactive 8
Urinary Incontinence 1
Enuresis 1
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Clinical Trial Locations for Fesoterodine Fumarate

Trials by Country

Trials by Country for Fesoterodine Fumarate
Location Trials
United States 49
Japan 29
Spain 7
Korea, Republic of 6
United Kingdom 5
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Trials by US State

Trials by US State for Fesoterodine Fumarate
Location Trials
North Carolina 3
Alabama 2
Ohio 2
New York 2
Texas 2
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Clinical Trial Progress for Fesoterodine Fumarate

Clinical Trial Phase

Clinical Trial Phase for Fesoterodine Fumarate
Clinical Trial Phase Trials
Phase 4 2
Phase 3 4
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Fesoterodine Fumarate
Clinical Trial Phase Trials
Completed 8
Terminated 2
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Clinical Trial Sponsors for Fesoterodine Fumarate

Sponsor Name

Sponsor Name for Fesoterodine Fumarate
Sponsor Trials
Pfizer 8
National Institute on Aging (NIA) 1
Mayo Clinic 1
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Sponsor Type

Sponsor Type for Fesoterodine Fumarate
Sponsor Trials
Industry 8
Other 2
NIH 1
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Serving hundreds of leading biopharmaceutical companies globally:

UBS
Boehringer Ingelheim
McKesson
Healthtrust
Baxter
Merck
Johnson and Johnson
Cerilliant
Medtronic

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