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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: Clinical Trial Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT01227512 is a Phase 3 study that was terminated before completion, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 124 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
LoS was time to clinically ready to be hospital discharged (CRBD) from study treatment initiation, disregarding prolonged hospitalization due solely to social factors.
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 |
Why NCT01227512 stopped before completion
NCT01227512 is an interventional study that assigns participants to a tested intervention. The registered 124 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 2 interventions - of which tolvaptan is the first listed.
NCT01227512 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01227512's enrollment target sits among peer trials
124 1610th of 2000 higher than 386 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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