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| Sponsored by: |
Pfizer |
|---|---|
| Information provided by: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00611026 |
Purpose
To evaluate the efficacy and safety of fesoterodine in comparison to tolterodine and placebo for overactive bladder
| Condition | Intervention | Phase |
|---|---|---|
|
Overactive Bladder |
Drug: Tolterodine ER Drug: Placebo Drug: Fesoterodine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study |
| Official Title: | 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. |
| Estimated Enrollment: | 2160 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | January 2010 |
| Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Active Comparator |
Drug: Tolterodine ER
The tolterodine treatment will be 4 mg QD for 12 weeks.
|
| 2: Placebo Comparator |
Drug: Placebo
Placebo treatment will be QD for 12 weeks.
|
| 3: Experimental |
Drug: Fesoterodine
The fesoterodine treatment will start with 4 mg QD for 1 week followed by a forced dose-escalation to 8mg QD for 11 weeks.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Show 234 Study Locations| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
| Responsible Party: | Pfizer Inc ( Director, Clinical Trial Disclosure Group ) |
| Study ID Numbers: | A0221046 |
| Study First Received: | January 28, 2008 |
| Last Updated: | June 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00611026 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Treatment of overactive bladder |
|
Muscarinic Antagonists Signs and Symptoms Urinary Bladder, Overactive Neurotransmitter Agents Cystocele |
Cholinergic Antagonists Urologic Diseases Urinary Bladder Diseases Cholinergic Agents Tolterodine |
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Urinary Bladder, Overactive Neurotransmitter Agents Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Urinary Bladder Diseases Physiological Effects of Drugs Cholinergic Agents |
Pharmacologic Actions Muscarinic Antagonists Urological Manifestations Signs and Symptoms Urologic Diseases Tolterodine |