drugset / Trial / NCT02138747

A Study to Evaluate Tolerability and Participants Preference Between Mirabegron and Tolterodine Extended Release (ER) in Participants With Overactive Bladder (OAB)

NCT02138747 ↗

Phase 4 Completed 376 enrolled Astellas Pharma Global Development, Inc.
RandomizedCrossoverDouble-blindTreatment

Summary

The purpose of this study was to assess tolerability of mirabegron compared to tolterodine ER in the treatment of participants with symptoms of Overactive Bladder (OAB) as well as the impact of treatment on micturition frequency and incontinence episodes.

Timeline

Start
2014-07-24
Primary completion
2015-10-29
Completion
2015-11-11

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

registry analysis (unspecified test); Mirabegron vs Tolterodine ER; p = 0.004; LS Mean Difference -2.89 (95% CI -4.86 to -0.93); ANOVA NCT02138747 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Mirabegron Other / unclassified 50 mg Oral
Subject Tolterodine Unknown 4 mg Oral

Indications