CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 2,012 enrolled
Drug / intervention
Fesoterodine 8mg +2 moredrug
Likely dose
Fesoterodine 8mgfrom 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.

Search/NCT01302067
NCT01302067Phase 4Completed
CompareCT.gov

A 12-Week, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Trial In Overactive Bladder Subjects To Confirm The Efficacy Of 8 Mg Fesoterodine Compared To 4 Mg Fesoterodine.

Pfizer·interventional·Posted Feb 23, 2011·Updated Mar 26, 2014

In Brief

A Phase 4 clinical trial evaluating Fesoterodine 8mg, Fesoterodine 4mg, and 1 other intervention for Overactive Bladder. Completed, enrolled 2,012 participants across 293 sites in 27 countries.

Detailed Summary

This study is designed to confirm if 8mg of fesoterodine is more effective in reducing overactive bladder symptoms than 4mg of fesoterodine. In addition the study is designed to assess if the higher dose reduces the overall effect of overactive bladder on the subject's daily life more than the lower dose. The study also assesses the side effects and safety of the two doses.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOveractive Bladder
CountriesArgentina, Canada, Chile, Colombia, Czechia, Denmark, Egypt, Finland, France, Germany, Greece, Hungary, Italy, Lithuania, Mexico, Norway, Philippines, Poland, Russia, Slovakia, South Africa, South Korea, Sweden, Taiwan, Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 23, 2011
Enrollment StartMay 1, 2011
Primary CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 15.4 years ago

Interventions

Fesoterodine 8mgdrug

Oral, 1 tablet per day, 12 weeks duration, 8mg/day

Fesoterodine 4mgdrug

Oral, 1 tablet per day, 12 weeks duration, 4mg/day

Placebodrug

Oral, 1 tablet per day, 12 weeks duration