Study of the Safety and Effectiveness of SAMSCA® (Tolvaptan) in Children and Adolescents With Euvolemic or Hypervolemic Hyponatremia
Stopped early · Phase 3
Conditions studied: Hyponatremia
In brief
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.
Key facts
- Study ID
- NCT02012959
- Run by
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- People needed
- 9
- Starts
- 2015-09-22
- Expected to finish
- 2017-07-24
- Last updated by the study team
- 2018-09-26
Who can join
Age: 0 and older, up to 17. 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 — New York, New York, United States
- Study site — Richmond, Virginia, United States
- Study site — Seattle, Washington, United States
- Study site — Rome, Italy
- Study site — London, United Kingdom
Full record on ClinicalTrials.gov
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