A multicentre, open-label, single dose, phase 1 study to evaluate the pharmacokinetics, safety and tolerability of mirabegron oral suspension in pediatric subjects from 3 to less than 12 years of age with neurogenic detrusor overactivity (NDO) or overactive bladder (OAB)

Trial Profile

A multicentre, open-label, single dose, phase 1 study to evaluate the pharmacokinetics, safety and tolerability of mirabegron oral suspension in pediatric subjects from 3 to less than 12 years of age with neurogenic detrusor overactivity (NDO) or overactive bladder (OAB)

Completed
Phase of Trial: Phase I

Latest Information Update: 21 Nov 2016

At a glance

  • Drugs Mirabegron (Primary)
  • Indications Bladder dysfunction; Overactive bladder
  • Focus Pharmacokinetics
  • Sponsors Astellas Pharma
  • Most Recent Events

    • 11 Oct 2016 Status changed from recruiting to completed.
    • 02 Sep 2016 Planned End Date changed from 1 Dec 2016 to 1 Mar 2017.
    • 02 Sep 2016 Planned primary completion date changed from 1 Dec 2016 to 1 Mar 2017.
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