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Open-label Phase 3 Study With Mirabegron in Children From 3 to Less Than 18 Years of Age With Neurogenic Detrusor Overactivity

NCT02751931 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2024-11-12

Study results available
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Summary

The objective of the study was to evaluate the efficacy, safety, tolerability and pharmacokinetics of mirabegron after multiple-dose administration in the pediatric population.

Conditions

  • Neurogenic Detrusor Overactivity

Interventions

DRUG

Mirabegron

Participants received initial dose of 25 mg of mirabegron PED25 orally once daily. At weeks 2, 4 or 8, participants were up-titrated to PED50 based on the given dose titration criteria. Following week 24, participants stayed on their individual dose level until week 52 EOS or EOT. Participants with a body weight \>=35 kg received mirabegron tablets or body weight \<35 kg received mirabegron oral suspension. At week 24, participants on mirabegron oral suspension could switch to tablets if the body weight became \>=35 kg or participants on mirabegron tablets could switch to oral suspension if the body weight became \<35 Kg or participants could switch to either of the dosage form for acceptability reasons after sponsor's prior approval and on a case-by-case basis. Mirabegron extended-release granules were reconstituted with water to prepare a mirabegron oral suspension of 8 mg/mL. Administration was via an oral syringe with a sip of water afterwards.

Sponsors & Collaborators

  • Astellas Pharma Europe B.V.

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Astellas Pharma Europe B.V.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2016-06-17
Primary Completion
2018-11-05
Completion
2019-05-06

Countries

  • Australia
  • Belgium
  • Croatia
  • Denmark
  • Israel
  • Jordan
  • Latvia
  • Lithuania
  • Malaysia
  • Mexico
  • Norway
  • Philippines
  • Poland
  • Romania
  • Serbia
  • Slovakia
  • South Korea
  • Taiwan
  • Turkey (Türkiye)

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 NCT02751931 on ClinicalTrials.gov