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Generated: December 14, 2018

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CLINICAL TRIALS PROFILE FOR TOVIAZ

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Clinical Trials for Toviaz

Trial ID Title Status Sponsor Phase Summary
NCT00605319 An Open Label Study to Measure Efficacy of Fesoterodine (Toviaz) Post Surgery for Benign Prostatic Hyperplasia Unknown status Pfizer Phase 4 The subjects who have symptoms of overactive bladder (many trips to the bathroom, and urgency with or without the inability to hold your urine until you get to the toilet) are invited to participate in this research study. Overactive bladder is a common sequelae of long-term bladder outlet obstruction in men. Unfortunately, it does not often resolve after treatment of the obstruction (transurethral resection of the prostate). These patients are usually started empirically on alpha-blockers or occasionally anticholinergic agents, former used to treat enlarged prostate medically, and latter, to treat overactive bladder. We hypothesize that these patients would be significantly improved with a long-acting anticholinergic agent such as long acting Fesoterodine or Toviaz. Earlier studies have shown that anticholinergic drugs seem to have a beneficial effect on symptoms of patients with bladder outlet obstruction and overactive bladder. In addition, anticholinergic drug Toviaz is not associated with increased incidence of complication like acute urinary retention, a state where patient is unable to empty the bladder as an adverse effect of the drug. A large proportion of our patients that are undergoing treatment for bladder outlet obstruction also have overactive bladder. We propose an open label trial to evaluate the efficacy of Toviaz (fesoterodine) 4mg to 8 mg in patients that have continued symptoms of overactive bladder one month following transurethral resection of the prostate. Toviaz is an antimuscarinic and anticholinergic agent, and is a newer formulation of Detrol. Patients with overactive bladder on urodynamic test preoperatively will be considered. If these patients continue to have symptoms at the one-month post-operative visit, they will be enrolled into the study. We expect a total of 25 patients to be enrolled within 4 months. All patients will receive Toviaz 4mg to 8 mg. The patients will be followed at 3 months post-op, 4 months post-op, and 7 months post-op. At each post-op visit, the patients will fill out an AUA symptom score questionnaire, have noninvasive uroflowmetry performed, and have a post-void residual measured by bladder scan. Using standard statistical analysis, we will see if there is a difference in symptoms, post-void residual, or maximum flow rate between baseline and 7 months post-op. We will continue the study to evaluate long-term efficacy, dropout rate, and complications. An FDA approved flexible dosing regimen will be allowed for the duration of the study.
NCT00605319 An Open Label Study to Measure Efficacy of Fesoterodine (Toviaz) Post Surgery for Benign Prostatic Hyperplasia Unknown status Weill Medical College of Cornell University Phase 4 The subjects who have symptoms of overactive bladder (many trips to the bathroom, and urgency with or without the inability to hold your urine until you get to the toilet) are invited to participate in this research study. Overactive bladder is a common sequelae of long-term bladder outlet obstruction in men. Unfortunately, it does not often resolve after treatment of the obstruction (transurethral resection of the prostate). These patients are usually started empirically on alpha-blockers or occasionally anticholinergic agents, former used to treat enlarged prostate medically, and latter, to treat overactive bladder. We hypothesize that these patients would be significantly improved with a long-acting anticholinergic agent such as long acting Fesoterodine or Toviaz. Earlier studies have shown that anticholinergic drugs seem to have a beneficial effect on symptoms of patients with bladder outlet obstruction and overactive bladder. In addition, anticholinergic drug Toviaz is not associated with increased incidence of complication like acute urinary retention, a state where patient is unable to empty the bladder as an adverse effect of the drug. A large proportion of our patients that are undergoing treatment for bladder outlet obstruction also have overactive bladder. We propose an open label trial to evaluate the efficacy of Toviaz (fesoterodine) 4mg to 8 mg in patients that have continued symptoms of overactive bladder one month following transurethral resection of the prostate. Toviaz is an antimuscarinic and anticholinergic agent, and is a newer formulation of Detrol. Patients with overactive bladder on urodynamic test preoperatively will be considered. If these patients continue to have symptoms at the one-month post-operative visit, they will be enrolled into the study. We expect a total of 25 patients to be enrolled within 4 months. All patients will receive Toviaz 4mg to 8 mg. The patients will be followed at 3 months post-op, 4 months post-op, and 7 months post-op. At each post-op visit, the patients will fill out an AUA symptom score questionnaire, have noninvasive uroflowmetry performed, and have a post-void residual measured by bladder scan. Using standard statistical analysis, we will see if there is a difference in symptoms, post-void residual, or maximum flow rate between baseline and 7 months post-op. We will continue the study to evaluate long-term efficacy, dropout rate, and complications. An FDA approved flexible dosing regimen will be allowed for the duration of the study.
NCT00691093 Study In Patients With Overactive Bladder Treated With Toviaz® After Failure Of Previous Therapy Completed Pfizer Phase 4 This is a observational study in patients treated with fesoterodine (Toviaz), who have failed on previous treatment for overactive bladder. It will collect epidemiological data and investigate the efficacy and tolerability of fesoterodine.
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 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.
NCT00879398 Toviaz Post Marketing Surveillance Study Completed Pfizer N/A The objective of this study is to determine the problems and questions of safety and efficacy of Toviaz® under the standard conditions of usage.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Toviaz

Condition Name

Condition Name for Toviaz
Intervention Trials
Overactive Bladder 9
Urinary Bladder, Overactive 5
Treatment of Overactive Bladder 2
Mild Cognitive Impairment 1
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Condition MeSH

Condition MeSH for Toviaz
Intervention Trials
Urinary Bladder, Overactive 18
Enuresis 3
Urinary Incontinence 3
Parkinson Disease 1
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Clinical Trial Locations for Toviaz

Trials by Country

Trials by Country for Toviaz
Location Trials
United States 73
Canada 11
Korea, Republic of 6
United Kingdom 5
Spain 4
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Trials by US State

Trials by US State for Toviaz
Location Trials
Florida 3
Connecticut 3
New York 3
North Carolina 3
Missouri 3
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Clinical Trial Progress for Toviaz

Clinical Trial Phase

Clinical Trial Phase for Toviaz
Clinical Trial Phase Trials
Phase 4 8
Phase 3 2
Phase 2 3
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Clinical Trial Status

Clinical Trial Status for Toviaz
Clinical Trial Phase Trials
Completed 12
Recruiting 4
Unknown status 3
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Clinical Trial Sponsors for Toviaz

Sponsor Name

Sponsor Name for Toviaz
Sponsor Trials
Pfizer 16
Stéphane Bolduc 2
Rambam Health Care Campus 1
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Sponsor Type

Sponsor Type for Toviaz
Sponsor Trials
Industry 17
Other 13
NIH 1
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