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

Stopped early · Phase 3

Conditions studied: Hyponatremia

In brief

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).

Key facts

Study ID

NCT02020278

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

3

Starts

2016-04-22

Expected to finish

2017-10-23

Last updated by the study team

2020-04-17

Who can join

Age: 4 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Study site — Aurora, Colorado, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Atlanta, Georgia, United States
• Study site — Grand Rapids, Michigan, United States
• Study site — Kansas City, Missouri, United States
• Study site — New York, New York, United States
• Study site — Stony Brook, New York, United States
• Study site — The Bronx, New York, United States
• Study site — Cleveland, Ohio, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Seattle, Washington, United States
• Study site — Ghent, Belgium
• Study site — Prague, Czechia
• Study site — Erlangen, Nurnberg, Germany
• Study site — Leipzig, Saxony, Germany
• Study site — Genova, Italy
• Study site — Naples, Italy
• Study site — Palermo, Italy
• Study site — Rome, Italy
• Study site — Bucharest, Romania
• Study site — Sibiu, Romania
• Study site — Madrid, Spain
• Study site — London, United Kingdom

Full record on ClinicalTrials.gov

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