An Extension Follow-up Trial to Evaluate the Long-term Safety of Children and Adolescent Participants With Euvolemic or Hypervolemic Hyponatremia

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

Outcome

Outcome not reported

Stopped (Enrollment): “Issues with recruitment and enrollment made the trial impossible or highly impracticable. Termination of this trial was not due to safety reasons.”

Drugs

Indications

No indication recorded.