A Study to Evaluate Mirabegron in Pediatric Participants From 5 to Less Than 18 Years of Age With Overactive Bladder (OAB) (Dolphin)

  • STATUS
    Not Recruiting
  • End date
    Jun 30, 2024
  • participants needed
    432
  • sponsor
    Astellas Pharma Global Development, Inc.
Updated on 15 September 2023
mirabegron
incontinence

Summary

The purpose of this study is to evaluate the efficacy of mirabegron in children (5 to < 12 years of age) with OAB.

This study will also evaluate the safety and tolerability of mirabegron in pediatric participants with OAB and evaluate the pharmacokinetics after multiple dose administration of mirabegron in pediatric participants with OAB.

Description

The study consists of 3 periods (Screening period/urotherapy (4 weeks); Double-blind, placebo-controlled period (12 weeks); Follow-up period (2 weeks)) for a total duration of 18 weeks.

Details
Condition Overactive Bladder (OAB), Pharmacokinetics of Mirabegron
Treatment Placebo, mirabegron
Clinical Study IdentifierNCT04641975
SponsorAstellas Pharma Global Development, Inc.
Last Modified on15 September 2023

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