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)
Phase of Trial: Phase III
Latest Information Update: 19 Jul 2017
At a glance
- Drugs Tolvaptan (Primary)
- Indications Hyponatraemia
- Focus Registrational; Therapeutic Use
- Sponsors Otsuka Pharmaceutical Development & Commercialization
- 24 Apr 2017 Planned End Date changed from 1 Dec 2018 to 1 May 2020.
- 24 Apr 2017 Planned primary completion date changed from 1 Dec 2018 to 1 May 2020.
- 29 Apr 2016 Status changed from not yet recruiting to recruiting.