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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: Completed Phase 3 study of Liver Cirrhosis and Portal Hypertension, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

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. According to ClinicalTrials.gov, the official US trial registry.

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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).

Primary Outcome

Development of varices

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

FieldValue
Enrollment Target 213 participants
Start Date 1993-08
Est. Completion 2002-09
Phase Phase 3

What the finished NCT00006398 record still lists

NCT00006398 is an interventional study that assigns participants to a tested intervention. The registered 213 participants enrollment target is mid-sized for trials with a published cap, below the 991-participant average among 15 other Liver Cirrhosis trials with a reported enrollment target (79% lower).

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 lists 5 locations in 4 states (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.

Similar trials for Liver Cirrhosis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00006398's enrollment target sits among peer trials

213 8th of 15 higher than 8 of 15 other Liver Cirrhosis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Liver Cirrhosis 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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Source: ClinicalTrials.gov NCT00006398, the US trial registry maintained by the National Library of Medicine. NCT00006398 (mid enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.