An Extension Follow-up Trial to Evaluate the Long-term Safety of Children

Status Terminated

Clinical Trial 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).

Clinical Trial Description

Core Safety Follow-up Component

• For all participants: To evaluate the post-treatment safety follow-up of children and adolescent participants with dilutional (euvolemic or hypervolemic) hyponatremia who have previously participated in a tolvaptan hyponatremia trial.

Optional Tolvaptan Treatment Component

• For participants who receive optional tolvaptan treatment: To demonstrate that tolvaptan safely and effectively achieves and maintains increased serum sodium concentrations in children and adolescent participants with dilutional (euvolemic or hypervolemic) hyponatremia when used for both multiple short-term treatments, and/or longer chronic treatments. ;

Study Design

Related Conditions & MeSH terms

Hyponatremia

Clinical Trial Details

NCT number	NCT02020278
Study type	Interventional
Source	Otsuka Pharmaceutical Development & Commercialization, Inc.
Contact
Status	Terminated
Phase	Phase 3
Start date	April 22, 2016
Completion date	October 23, 2017

View Details

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms