At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 2,417 enrolled
Drug / intervention
Tolterodine ER +2 moredrug
Likely dose
Tolterodine ER 4 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 3 clinical trial evaluating Tolterodine ER, Placebo, and 1 other intervention for Overactive Bladder. Completed, enrolled 2,417 participants across 227 sites in 25 countries.
Detailed Summary
To evaluate the efficacy and safety of fesoterodine in comparison to tolterodine and placebo for overactive bladder
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOveractive Bladder
CountriesBrazil, Bulgaria, Canada, Colombia, Costa Rica, Estonia, Germany, Greece, Hungary, India, Ireland, Latvia, Lithuania, Malaysia, Poland, Romania, Russia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2008
First PostedFeb 2008
Primary CompletionOct 2009
TodayJul 2026
First PostedFeb 8, 2008
Enrollment StartFeb 1, 2008
Primary CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 18.4 years ago
Interventions
Tolterodine ERdrug
The tolterodine treatment will be 4 mg once daily(QD) for 12 weeks.
Placebodrug
Placebo treatment will be once daily(QD) for 12 weeks.
Fesoterodinedrug
The fesoterodine treatment will start with 4 mg once daily(QD) for 1 week followed by a forced dose-escalation to 8mg once daily(QD) for 11 weeks.