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NCT00409084 · ClinicalTrials.gov registry record · Phase 3
Beta Blockers Versus Variceal Band Ligation and Beta Blockers for Primary Prophylaxis of Variceal Bleeding
A Phase 3 study, sponsored by Virginia Commonwealth University.
- Terminated
- Registry status
- Phase 3
- Development phase
- 2
- Enrollment target
NCT00409084 is a Phase 3 study that was terminated before completion, run by Virginia Commonwealth University. The registered enrollment target is 2 participants.
The verdict
NCT00409084, a Phase 3 study, was terminated before completion, sponsored by Virginia Commonwealth University.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 2 participants
- Enrollment target
Study Summary
Patients with scarring of the liver (cirrhosis) and portal hypertension (elevated blood pressure in the liver vasculature) can develop esophageal varices (dilated veins). These have an increased risk of bleeding each year. Current recommendations are to prevent bleeding of medium or large varices (when there is no history of bleeding) by starting a blood pressure lowering agent known as a non-selective beta-blocker. Alternatively, rubber bands can be placed on medium to large varices to prevent bleeding (endoscopic variceal band ligation). Using both therapies at the same time has not been studied. In this study, we hope to determine if the use of combination therapy with endoscopic variceal band ligation and beta blockers is more effective than using beta blockers alone to prevent the first bleeding episode from the varices (dilated veins). The efficacy, ability to tolerate, and cost-effectiveness of these two treatment strategies will be compared.
Interventions
- PROCEDURE endoscopic variceal band ligation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2006-12 |
| Est. Completion | 2009-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00409084
The ClinicalTrials.gov registry entry for NCT00409084 describes a study currently listed as terminated, categorized as Phase 3. 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 Virginia Commonwealth University, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which endoscopic variceal band ligation is the first listed.
NCT00409084 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00409084 about?
NCT00409084 is a clinical study titled "Beta Blockers Versus Variceal Band Ligation and Beta Blockers for Primary Prophylaxis of Variceal Bleeding". Patients with scarring of the liver (cirrhosis) and portal hypertension (elevated blood pressure in the liver vasculature) can develop esophageal varices (dilated veins). These have an increased risk of bleeding each year. Current recommendations are to prevent bleeding of medium or large varices (w...
What is the current status of trial NCT00409084?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 2 participants. The study started on 2006-12. Estimated completion is 2009-06.
What interventions are being tested in trial NCT00409084?
The interventions under investigation include: endoscopic variceal band ligation (PROCEDURE).
Who is sponsoring clinical trial NCT00409084?
This trial is sponsored by Virginia Commonwealth University, which has 558 total clinical trials registered on ClinicalTrials.gov.
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