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

NCT04641975 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2024-11-14

Study results available
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Summary

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

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

Conditions

  • Overactive Bladder (OAB)
  • Pharmacokinetics of Mirabegron

Interventions

DRUG

Mirabegron

Oral/ Oral Suspension: Participants with a body weight of ≥ 35 kg are to receive the tablet form of IP unless unable to swallow tablets and will be provided the oral suspension as an alternative. Participants with a body weight \< 35 kg or those who cannot be dosed with the tablet will receive oral suspension.

DRUG

Placebo

Oral/ Oral Suspension

Sponsors & Collaborators

  • Astellas Pharma Global Development, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Astellas Pharma Global Development, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-15
Primary Completion
2023-07-07
Completion
2023-07-24
FDA Drug
Yes

Countries

  • Belgium
  • France
  • Malaysia
  • Norway
  • Philippines
  • Russia
  • South Korea
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT04641975 on ClinicalTrials.gov