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A Phase 3b, Multicenter, Open-label, Randomized Withdrawal Trial of the Effects of Titrated Oral SAMSCA (Tolvaptan) on Serum Sodium, Pharmacokinetics, and Safety in Children and Adolescent Subjects Hospitalized With Euvolemic or Hypervolemic Hyponatremia

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Trial Profile

A Phase 3b, Multicenter, Open-label, Randomized Withdrawal Trial of the Effects of Titrated Oral SAMSCA (Tolvaptan) on Serum Sodium, Pharmacokinetics, and Safety in Children and Adolescent Subjects Hospitalized With Euvolemic or Hypervolemic Hyponatremia

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 21 Jul 2022

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At a glance

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

    • Most Recent Events

    • 25 Oct 2017 Status changed from recruiting to discontinued.
    • 29 Aug 2017 This trial has been Discontinued in Spain (end date: 24 Jul 2017).
    • 05 Aug 2017 This trial has been completed in Belgium (end date: 24 Jul 2017).

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