CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 649 enrolled
Drug / intervention
Mirabegron tablet +4 moredrug
Likely dose
Imidafenacin tablet 0.1 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.

Search/NCT02294396
NCT02294396Phase 4Completed
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Postmarketing Study of Mirabegron in Japan: Long-term Add-on Therapy With Antimuscarinics in Patients With Overactive Bladder Treated With Mirabegron

Astellas Pharma Inc·interventional·Posted Nov 19, 2014·Updated Oct 31, 2024

In Brief

A Phase 4 clinical trial evaluating Mirabegron tablet, Solifenacin tablet, and 3 other interventions for Overactive Bladder (OAB). Completed, enrolled 649 participants across 7 sites.

Detailed Summary

The objective of the study was to evaluate the safety and efficacy of add-on therapy with anticholinergics in patients with OAB on mirabegron.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOveractive Bladder (OAB)
CountriesJapan
Collaborators--

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 19, 2014
Enrollment StartOct 28, 2014
Primary CompletionSep 7, 2016
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 11.6 years ago

Interventions

Mirabegron tabletdrug

orally administered at a dose of 1 tablet once daily after breakfast

Solifenacin tabletdrug

orally administered at a dose of 1 tablet once daily after breakfast (could be increased to 2 tablets)

Propiverine tabletdrug

orally administered at a dose of 1 tablet once daily after breakfast (could be increased to 1 tablet twice daily after breakfast and after dinner)

Imidafenacin tabletdrug

orally administered at a dose of 1 tablet (0.1 mg tablet) twice daily after breakfast and after dinner (could be increased to 2 tablets twice daily after breakfast and after dinner)

Tolterodine capsuledrug

orally administered at a dose of 1 capsule once daily after breakfast (could not be increased)