A Phase 3b, Multicenter, Extension Follow-up Trial to Evaluate the Long-term Safety of Children and Adolescent Subjects With Euvolemic or Hypervolemic Hyponatremia Who Have Previously Participated in a Trial of Titrated Oral SAMSCA (Tolvaptan)

Trial Profile

A Phase 3b, Multicenter, Extension Follow-up Trial to Evaluate the Long-term Safety of Children and Adolescent Subjects With Euvolemic or Hypervolemic Hyponatremia Who Have Previously Participated in a Trial of Titrated Oral SAMSCA (Tolvaptan)

Discontinued
Phase of Trial: Phase III

Latest Information Update: 30 Nov 2017

At a glance

  • Drugs Tolvaptan (Primary)
  • Indications Hyponatraemia
  • Focus Registrational; Therapeutic Use
  • Sponsors Otsuka Pharmaceutical Development & Commercialization
  • Most Recent Events

    • 08 Nov 2017 This study has been completed in Belgium as per European Clinical Trials Database.
    • 27 Oct 2017 Status changed from active, no longer recruiting to discontinued.
    • 10 Oct 2017 This trial has been completed in Czech Republic, according to European Clinical Trials Database
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