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Prevention of Esophageal Varices by Beta-Adrenergic Blockers
NCT00006398 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 213 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 375 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00006398 reports 5 study locations spanning 4 distinct geographic areas — top geographies include Connecticut, Massachusetts, Catalonia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00006398?
The interventions under investigation include: Placebo (DRUG), Timolol Maleate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00006398?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 375 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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