NCT00006398

Prevention of Esophageal Varices by Beta-Adrenergic Blockers

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 213 (actual)
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

• Esophageal and Gastric Varices
• Liver Cirrhosis
• Portal Hypertension

Interventions

Type	Name	Description
DRUG	Timolol Maleate
DRUG	Placebo

Timeline

• Start date: 1993-08-01
• Primary completion: 2002-09-01
• Completion: 2002-09-01
• First posted: 2000-10-06
• Last updated: 2017-06-01

Locations

5 sites across 3 countries: United States, Spain, United Kingdom

Regulatory

• FDA-regulated drug study