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
Phase of Trial: Phase III
Latest Information Update: 29 Jan 2018
At a glance
- Drugs Tolvaptan (Primary)
- Indications Hyponatraemia
- Focus Registrational; Therapeutic Use
- Sponsors Otsuka Pharmaceutical Development & Commercialization
- 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).