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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00546637 |
To evaluate the efficacy and safety of fesoterodine on overactive bladder symptom improvement when added to ongoing alpha blocker treatment.
Condition | Intervention | Phase |
---|---|---|
Overactive Bladder Syndrome |
Drug: Fesoterodine Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of Fesoterodine As An "Add-On" Therapy In Men With Persistent Overactive Bladder Symptoms Under Monotherapy Of Alpha Blocker For Lower Urinary Tract Symptoms. |
Estimated Enrollment: | 900 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Fesoterodine 4mg or 8mg: Experimental |
Drug: Fesoterodine
Fesoterodine 4mg or 8mg
|
Placebo: Placebo Comparator |
Drug: Placebo
Placebo
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Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer,Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A0221009 |
Study First Received: | October 18, 2007 |
Last Updated: | January 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00546637 |
Health Authority: | United States: Food and Drug Administration |
Signs and Symptoms Urinary Bladder, Overactive Cystocele Urologic Diseases Urinary Bladder Diseases |
Urological Manifestations Pathologic Processes Disease Syndrome |