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NCT01227512 · ClinicalTrials.gov registry record · Phase 3
Effects of Tolvaptan vs Fluid Restriction in Hospitalized Subjects With Dilutional Hyponatremia
A Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Terminated
- Registry status
- Phase 3
- Development phase
- 124
- Enrollment target
NCT01227512 is a Phase 3 study that was terminated before completion, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 124 participants.
The verdict
NCT01227512, a Phase 3 study, was terminated before completion, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 124 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if hospitalized patients with symptomatic hyponatremia treated with tolvaptan are in the hospital for less time than patients treated with fluid restriction. The study will also test if tolvaptan is better than fluid restriction in treating the symptoms of hyponatremia in hospitalized patients.
Interventions
- DRUG tolvaptan
- OTHER Fluid Restriction
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 124 participants |
| Start Date | 2010-10 |
| Est. Completion | 2013-05 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01227512
The ClinicalTrials.gov registry entry for NCT01227512 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 124 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 2 interventions - of which tolvaptan is the first listed.
NCT01227512 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01227512 about?
NCT01227512 is a clinical study titled "Effects of Tolvaptan vs Fluid Restriction in Hospitalized Subjects With Dilutional Hyponatremia". The purpose of this study is to determine if hospitalized patients with symptomatic hyponatremia treated with tolvaptan are in the hospital for less time than patients treated with fluid restriction. The study will also test if tolvaptan is better than fluid restriction in treating the symptoms of h...
What is the current status of trial NCT01227512?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 124 participants. The study started on 2010-10. Estimated completion is 2013-05.
What interventions are being tested in trial NCT01227512?
The interventions under investigation include: tolvaptan (DRUG), Fluid Restriction (OTHER).
Who is sponsoring clinical trial NCT01227512?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
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