CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 213 enrolled
Drug / intervention
Timolol Maleate +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00006398
NCT00006398Phase 3Completed

Randomized, Double-Blind Study of Timolol (A Nonselective Beta-Adrenergic Blocker) vs Placebo to Prevent Complications of Hepatic Portal Hypertension in Patients With Cirrhosis

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·interventional·Posted Oct 6, 2000·Updated Jun 1, 2017

In Brief

A Phase 3 clinical trial evaluating Timolol Maleate and Placebo for Esophageal and Gastric Varices and 2 related conditions. Completed, enrolled 213 participants across 5 sites in 3 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain, United Kingdom, United States
CollaboratorsYale University

Timeline

Phase 3CompletedFinished
19931994199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 6, 2000
Enrollment StartAug 1, 1993
Primary CompletionSep 1, 2002
TodayJul 2, 2026
Enrollment to primary: 9.1 yearsPosted 25.7 years ago

Interventions

Timolol Maleatedrug

Placebodrug