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Postmarketing Study to Evaluate add-on Therapy With Anticholinergics in Patients With Overactive Bladder (OAB) on Mirabegron.

NCT02294396 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 649

Last updated 2024-10-31

Study results available
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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.

Conditions

  • Overactive Bladder (OAB)

Interventions

DRUG

Mirabegron tablet

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

DRUG

Solifenacin tablet

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

DRUG

Propiverine tablet

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)

DRUG

Imidafenacin tablet

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)

DRUG

Tolterodine capsule

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

Sponsors & Collaborators

  • Astellas Pharma Inc

    lead INDUSTRY

Principal Investigators

  • Medical Director · Astellas Pharma Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-28
Primary Completion
2016-09-07
Completion
2016-09-07

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02294396 on ClinicalTrials.gov