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
Outcome
Outcome not reported
Stopped: “Trial withdrawn due to inability to meet the trial objectives (Pilot).”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Tolvaptan | Unknown | 3.75 mg | Oral |
| Comparator | Tolvaptan | Unknown | 7.5 mg | Oral |
| Comparator | Tolvaptan | Unknown | 15 mg | Oral |
| Comparator | Tolvaptan | Unknown | 30 mg | Oral |
| Comparator | Tolvaptan | Unknown | 60 mg | Oral |
Indications
No indication recorded.