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NCT00006398 · ClinicalTrials.gov registry record · Phase 3
Prevention of Esophageal Varices by Beta-Adrenergic Blockers
A Phase 3 study of Liver Cirrhosis and Portal Hypertension, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 3
- Development phase
- 213
- Enrollment target
- 5
- Study locations
NCT00006398 is a Phase 3 study of Liver Cirrhosis and Portal Hypertension that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 213 participants, below the 991-participant average among 15 other Liver Cirrhosis trials with a reported enrollment target (79% lower). The trial reports 5 study locations across 4 states.
The verdict
NCT00006398, a Phase 3 study of Liver Cirrhosis and Portal Hypertension, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 213 participants
- Enrollment target
- 5
- Study locations
Study Summary
The purpose of this study is to learn whether timolol is useful in preventing or delaying the appearance of gastroesophageal varices, a complication that may develop in the future as a consequence of liver disease. Cirrhosis causes an increased resistance of blood flowing through the liver. This leads to an increased pressure in the portal vein (the vein that takes blood to your liver). High portal pressure is responsible for the appearance of complications of chronic liver disease such as varices and variceal bleeding (bleeding from veins in your esophagus). Timolol belongs to a group of medications called beta-blockers. Beta-blockers decrease high portal pressure and previous studies have shown that beta-blocker pills are useful in preventing bleeding from varices in patients who already have varices. A more desirable effect would be if these pills could prevent not only bleeding from varices but the appearance of varices (and therefore of bleeding).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Timolol Maleate
Study Locations (5)
Connecticut
- Yale University Sch. of Medicine - New Haven
- VA CT Healthcare System - West Haven
Massachusetts
- The Faulkner Hospital - Boston
Catalonia
- Hospital Clinic I Provincial de Barcelona - Barcelona
London
- Royal Free Hospital - Hampstead
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 213 participants |
| Start Date | 1993-08 |
| Est. Completion | 2002-09 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00006398
The ClinicalTrials.gov registry entry for NCT00006398 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 213 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 991-participant average among 15 other Liver Cirrhosis trials with a reported enrollment target (79% lower). The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Liver Cirrhosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00006398 reports 5 study locations spanning 4 distinct geographic areas - top geographies include Connecticut, Massachusetts, Catalonia.
Frequently Asked Questions
What is clinical trial NCT00006398 about?
NCT00006398 is a clinical study titled "Prevention of Esophageal Varices by Beta-Adrenergic Blockers". The purpose of this study is to learn whether timolol is useful in preventing or delaying the appearance of gastroesophageal varices, a complication that may develop in the future as a consequence of liver disease. Cirrhosis causes an increased resistance of blood flowing through the liver. This lea...
What is the current status of trial NCT00006398?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 213 participants. The study started on 1993-08. Estimated completion is 2002-09.
What conditions does trial NCT00006398 study?
This clinical trial studies the following conditions: Liver Cirrhosis, Portal Hypertension, Esophageal and Gastric Varices.
What interventions are being tested in trial NCT00006398?
The interventions under investigation include: Placebo (DRUG), Timolol Maleate (DRUG).
Who is sponsoring clinical trial NCT00006398?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00006398 being conducted?
This trial has 5 study locations across Connecticut, Massachusetts, Catalonia, London. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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