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

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

Recruiting
Phase of Trial: Phase III

Latest Information Update: 11 Aug 2017

At a glance

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

    • 05 Aug 2017 This trial has been completed in Belgium (end date: 24 Jul 2017).
    • 14 Jul 2017 Planned End Date changed from 1 May 2017 to 1 Jul 2017.
    • 14 Jul 2017 Planned primary completion date changed from 1 May 2017 to 1 Jul 2017.
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