drugset / Trial / NCT02012959
Study of the Safety and Effectiveness of SAMSCA® (Tolvaptan) in Children and Adolescents With Euvolemic or Hypervolemic Hyponatremia
Phase 3
Terminated
9 enrolled
Otsuka Pharmaceutical Development & Commercialization, Inc.
Syneos Health · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this trial was to demonstrate that tolvaptan effectively and safely increases and maintains serum sodium concentrations in children and adolescent participants with euvolemic or hypervolemic hyponatremia.
Timeline
- Start
- 2015-09-22
- Primary completion
- 2017-07-24
- Completion
- 2017-07-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tolvaptan | Small molecule | — | Oral |
Indications
No indication recorded.