Overview

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

Status:
Terminated

Trial end date:
2017-10-23

Target enrollment:

Participant gender:

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).

Phase:

Phase 3

Details

Lead Sponsor:

Otsuka Pharmaceutical Development & Commercialization, Inc.

Collaborators:

INC Research
Syneos Health

Treatments:

Tolvaptan