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An Open-label, Baseline-controlled, Multicenter, Phase 3 Dose-titration Study Followed by a Fixed-dose Observation Period to Evaluate Efficacy, Safety and Pharmacokinetics of Mirabegron in Children and Adolescents From 3 to Less Than 18 Years of Age With Neurogenic Detrusor Overactivity (NDO) on Clean Intermittent Catheterization (CIC)

Trial Profile

An Open-label, Baseline-controlled, Multicenter, Phase 3 Dose-titration Study Followed by a Fixed-dose Observation Period to Evaluate Efficacy, Safety and Pharmacokinetics of Mirabegron in Children and Adolescents From 3 to Less Than 18 Years of Age With Neurogenic Detrusor Overactivity (NDO) on Clean Intermittent Catheterization (CIC)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 21 Oct 2022

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At a glance

  • Drugs Mirabegron (Primary)
  • Indications Overactive bladder
  • Focus Therapeutic Use
  • Acronyms Crocodile
  • Sponsors Astellas Pharma Europe Ltd
  • Most Recent Events

    • 26 Mar 2021 Acording to an Astellas Pharma media release, U.S. Food and Drug Administration (FDA) approved Myrbetriq(mirabegron extended-release tablets) for the treatment of NDO in pediatric patients aged three years and older who weigh 35 kg or more, and Myrbetriq Granules (mirabegron for extended-release oral suspension) for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged three years and older.The approval for the NDO indication was based on findings from this trial
    • 06 Jan 2021 Acording to an Astellas Pharma media release, U.S. FDA accepted priority review for its New Drug Application (NDA) for mirabegron for oral suspension and its supplemental New Drug Application (sNDA) for Myrbetriq (mirabegron) tablets for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged three years and older. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is March 28, 2021.The NDA and sNDA were based on findings this trial.
    • 26 Jun 2019 Status changed from active, no longer recruiting to completed.
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