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)

Recruiting
Phase of Trial: Phase III

Latest Information Update: 11 Oct 2017

At a glance

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

    • 17 Aug 2017 Planned End Date changed from 31 Aug 2019 to 1 Aug 2019.
    • 17 Aug 2017 Planned primary completion date changed from 15 Feb 2019 to 1 Feb 2019.
    • 23 May 2017 Planned primary completion date changed from 1 Aug 2019 to 15 Feb 2019.
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