Study of the Safety and Effectiveness of SAMSCA® (Tolvaptan) in Children and Adolescents With Euvolemic or Hypervolemic Hyponatremia

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

Outcome

Outcome not reported

Stopped (Enrollment): “Issues with participant recruitment \& enrollment which made the trial impossible or highly impracticable. Trial termination was not due to safety reasons.”

Drugs

Indications

No indication recorded.