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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 is a Phase 4 study that was terminated before completion, run by NYU Langone Health. The registered enrollment target is 2 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01890694
The ClinicalTrials.gov registry entry for NCT01890694 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT01890694 reports 0 study locations.
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.
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