A Pilot Phase 3b,Multicenter,Randomized,Double-blind,Placebo-controlled Trial of the Safety,Efficacy,and Pharmacokinetics of Titrated Oral SAMSCA (Tolvaptan) in Children and Adolescent Subjects With Euvolemic or Hypervolemic Hyponatremia
Phase of Trial: Phase III
Latest Information Update: 07 Feb 2018
At a glance
- Drugs Tolvaptan (Primary)
- Indications Hyponatraemia
- Focus Registrational; Therapeutic Use
- Sponsors Otsuka Pharmaceutical Development & Commercialization
- 14 Jul 2017 This trial has been discontinued Germany (end date: 2017-06-22)
- 22 Nov 2016 Planned End Date changed from 1 Aug 2016 to 1 Aug 2017.
- 22 Nov 2016 Planned primary completion date changed from 1 Aug 2016 to 1 Aug 2017.