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NCT01890694 · ClinicalTrials.gov registry record · Phase 4
Tolvaptan to Reduce Length of Stay in Hospitalized Patients With Cirrhosis and Hyponatremia
A Phase 4 study, sponsored by NYU Langone Health.
- Terminated
- Registry status
- Phase 4
- Development phase
- 2
- Enrollment target
NCT01890694: Clinical Trial Phase 4 study, sponsored by NYU Langone Health.
NCT01890694 is a Phase 4 study that was terminated before completion, run by NYU Langone Health. The registered enrollment target is 2 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01890694, a Phase 4 study, was terminated before completion, sponsored by NYU Langone Health.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 2 participants
- Enrollment target
Study Summary
Hyponatremia is a condition in which there is a low sodium level in the blood. Individuals with cirrhosis may develop low blood sodium as a complication of their liver disease. In these patients, the presence of low blood sodium may exacerbate other complications such as encephalopathy, resulting in confusion, drowsiness, or coma. It may also affect the ability of the body to fight infection. In certain cases, cirrhotic patients may be hospitalized for the treatment of their low blood sodium. The drug tolvaptan is currently FDA approved for the treatment of hyponatremia in patients with cirrhosis. Although it has been shown to increase the sodium level, the clinical trials that led to its approval did not otherwise assess clinical benefit of the drug. This study is designed to determine whether patients with cirrhosis derive a clinical benefit when they receive tolvaptan for the treatment of hyponatremia within 2 days of admission. Specifically, whether it is associated with shortened length of stay and improvement in other complications of cirrhosis.
Primary Outcome
Performance period for sponsored trial expired and not enough subjects were enrolled in study. Funding sponsor did not continue support.
Interventions
- DRUG Placebo
- BEHAVIORAL Quality of Life Assessment
- DRUG Tolvaptan
- BEHAVIORAL Hepatic Encephalopathy Assessment
- BIOLOGICAL Vital signs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2012-03 |
| Est. Completion | 2015-03 |
| Phase | Phase 4 |
Why NCT01890694 stopped before completion
NCT01890694 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT01890694 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01890694 about?
NCT01890694 is a clinical study titled "Tolvaptan to Reduce Length of Stay in Hospitalized Patients With Cirrhosis and Hyponatremia". Hyponatremia is a condition in which there is a low sodium level in the blood. Individuals with cirrhosis may develop low blood sodium as a complication of their liver disease. In these patients, the presence of low blood sodium may exacerbate other complications such as encephalopathy, resulting in...
What is the current status of trial NCT01890694?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 2 participants. The study started on 2012-03. Estimated completion is 2015-03.
What interventions are being tested in trial NCT01890694?
The interventions under investigation include: Placebo (DRUG), Quality of Life Assessment (BEHAVIORAL), Tolvaptan (DRUG), Hepatic Encephalopathy Assessment (BEHAVIORAL), Vital signs (BIOLOGICAL).
Who is sponsoring clinical trial NCT01890694?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01890694's enrollment target sits among peer trials
2 1998th of 2000 higher than 1 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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