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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)

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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)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 29 May 2020

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At a glance

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

    • Most Recent Events

    • 26 May 2020 According to U.S FDA media release, it has granted approval to VESIcare LS (solifenacin succinate) oral suspension, a liquid taken by mouth, for the treatment of neurogenic detrusor overactivity (NDO), a form of bladder dysfunction related to neurological impairment, in children ages two years and older.
    • 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.
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