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NCT02012959 · ClinicalTrials.gov registry record · Phase 3
Study of the Safety and Effectiveness of SAMSCA® (Tolvaptan) in Children and Adolescents With Euvolemic or Hypervolemic Hyponatremia
A Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Terminated
- Registry status
- Phase 3
- Development phase
- 9
- Enrollment target
NCT02012959 is a Phase 3 study that was terminated before completion, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 9 participants.
The verdict
NCT02012959, a Phase 3 study, was terminated before completion, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 9 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Tolvaptan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2015-09-22 |
| Est. Completion | 2017-07-24 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02012959
The ClinicalTrials.gov registry entry for NCT02012959 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 221 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Tolvaptan is the first listed.
NCT02012959 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02012959 about?
NCT02012959 is a clinical study titled "Study of the Safety and Effectiveness of SAMSCA® (Tolvaptan) in Children and Adolescents With Euvolemic or Hypervolemic Hyponatremia". 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.
What is the current status of trial NCT02012959?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 9 participants. The study started on 2015-09-22. Estimated completion is 2017-07-24.
What interventions are being tested in trial NCT02012959?
The interventions under investigation include: Tolvaptan (DRUG).
Who is sponsoring clinical trial NCT02012959?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
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