drugset / Trial / NCT02020278
An Extension Follow-up Trial to Evaluate the Long-term Safety of Children and Adolescent Participants With Euvolemic or Hypervolemic Hyponatremia
Phase 3
Terminated
3 enrolled
Otsuka Pharmaceutical Development & Commercialization, Inc.
Syneos Health · collab
NaSingle-groupOpen-labelTreatment
Summary
The objective of this trial was to provide 6 months of safety follow-up for children and adolescents with dilutional (euvolemic or hypervolemic) hyponatremia who had previously participated in a tolvaptan hyponatremia trial and to assess the efficacy of tolvaptan in increasing serum sodium for those participants who received optional continuing tolvaptan treatment of variable duration (up to 6 months).
Timeline
- Start
- 2016-04-22
- Primary completion
- 2017-10-23
- Completion
- 2017-10-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tolvaptan | Small molecule | 3.75 mg | Oral |
| Subject | Tolvaptan | Small molecule | 7.5 mg | Oral |
| Subject | Tolvaptan | Small molecule | 15 mg | Oral |
| Subject | Tolvaptan | Small molecule | 30 mg | Oral |
| Subject | Tolvaptan | Small molecule | 60 mg | Oral |
Indications
No indication recorded.