A Phase 3, Double-Blind, Randomized, Multi-center, Placebo-Controlled Sequential Dose Titration Study to Assess Efficacy, Safety and Population Pharmacokinetics of Solifenacin Succinate Suspension in Pediatric Subjects From 5 to Less Than 18 Years of Age With Overactive Bladder (OAB).

Trial Profile

A Phase 3, Double-Blind, Randomized, Multi-center, Placebo-Controlled Sequential Dose Titration Study to Assess Efficacy, Safety and Population Pharmacokinetics of Solifenacin Succinate Suspension in Pediatric Subjects From 5 to Less Than 18 Years of Age With Overactive Bladder (OAB).

Completed
Phase of Trial: Phase III

Latest Information Update: 03 Apr 2017

At a glance

  • Drugs Solifenacin (Primary)
  • Indications Overactive bladder
  • Focus Registrational; Therapeutic Use
  • Acronyms LION
  • Sponsors Astellas Pharma Europe Ltd
  • Most Recent Events

    • 23 Jan 2014 As per the ClinicalTrials.gov record, Status changed from active, no longer recruiting to completed.
    • 08 Oct 2013 Status changed from recruiting to active, no longer recruiting as reported by ClinicalTrials.gov.
    • 09 May 2013 New source identified and integrated (United Kingdom Clinical Research Network: 13239).
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