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NCT02020278 · ClinicalTrials.gov registry record · Phase 3
An Extension Follow-up Trial to Evaluate the Long-term Safety of Children and Adolescent Participants With Euvolemic or Hypervolemic Hyponatremia
A Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Terminated
- Registry status
- Phase 3
- Development phase
- 3
- Enrollment target
NCT02020278: Clinical Trial Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT02020278 is a Phase 3 study that was terminated before completion, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 3 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02020278, a Phase 3 study, was terminated before completion, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 3 participants
- Enrollment target
Study 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).
Primary Outcome
No enrolled participant received any investigational medicinal product during the study. Due to early study termination, efficacy data were not collected for this outcome measure.
Interventions
- DRUG Tolvaptan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2016-04-22 |
| Est. Completion | 2017-10-23 |
| Phase | Phase 3 |
Why NCT02020278 stopped before completion
NCT02020278 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which Tolvaptan is the first listed.
NCT02020278 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02020278 about?
NCT02020278 is a clinical study titled "An Extension Follow-up Trial to Evaluate the Long-term Safety of Children and Adolescent Participants With Euvolemic or Hypervolemic Hyponatremia". 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...
What is the current status of trial NCT02020278?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 3 participants. The study started on 2016-04-22. Estimated completion is 2017-10-23.
What interventions are being tested in trial NCT02020278?
The interventions under investigation include: Tolvaptan (DRUG).
Who is sponsoring clinical trial NCT02020278?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02020278's enrollment target sits among peer trials
3 1999th of 2000 higher than 1 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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