A Phase 3, Open-Label, Baseline-controlled, Multicenter, Sequential Dose Titration Study to Assess the Long-Term Efficacy and Safety, and the Pharmacokinetics of Solifenacin Succinate Suspension in Patients From 5 to Less Than 18 Years of Age With Neurogenic Detrusor Overactivity (NDO)

Trial Profile

A Phase 3, Open-Label, Baseline-controlled, Multicenter, Sequential Dose Titration Study to Assess the Long-Term Efficacy and Safety, and the Pharmacokinetics of Solifenacin Succinate Suspension in Patients From 5 to Less Than 18 Years of Age With Neurogenic Detrusor Overactivity (NDO)

Completed
Phase of Trial: Phase III

Latest Information Update: 21 Apr 2017

At a glance

  • Drugs Solifenacin (Primary)
  • Indications Detrusor instability
  • Focus Registrational; Therapeutic Use
  • Sponsors Astellas Pharma Europe Ltd
  • Most Recent Events

    • 24 Jul 2016 Status changed from active, no longer recruiting to completed.
    • 28 Jul 2015 Planned End Date changed from 1 Aug 2016 to 1 May 2016 as reported by ClinicalTrials.gov.
    • 28 Jul 2015 Planned primary completion date changed from 1 Mar 2016 to 1 Apr 2016 as reported by ClinicalTrials.gov.
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