drugset / Trial / NCT02442674
A Trial of Tolvaptan in Children and Adolescent Subjects With Euvolemic and Hypervolemic Hyponatremia
RandomizedParallel-groupTriple-blindTreatment
Summary
The purpose of this trial is to demonstrate that tolvaptan effectively and safely increases and maintains serum sodium concentrations in children and adolescent subjects with euvolemic or hypervolemic hyponatremia.
Timeline
- Start
- 2015-11
- Primary completion
- 2017-06-22
- Completion
- 2017-06-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Tolvaptan | Small molecule | 3.75 mg | Oral |
| Comparator | Tolvaptan | Small molecule | 7.5 mg | Oral |
| Comparator | Tolvaptan | Small molecule | 15 mg | Oral |
| Comparator | Tolvaptan | Small molecule | 30 mg | Oral |
| Comparator | Tolvaptan | Small molecule | 60 mg | Oral |
Indications
No indication recorded.