Early Primary Prophylaxis of Esophageal Varices

Cirrhosis Clinical Trial

Official title: A Prospective, Double-blind, Randomized Placebo-controlled Trial of Carvedilol for Early Primary Prophylaxis of Esophageal Varices in Cirrhosis.

Status Completed

Clinical Trial Summary

Patients of cirrhosis with portal hypertension aged 18 to 75 years who have small esophageal varices with or without red color signs and have not bled previously will be enrolled. After baseline evaluation, the participants will be randomized to receive either Placebo or Carvedilol 12.5 mg BD. After randomization they will be followed up for one year. The primary endpoint of the study is the the proportions of patients who develop large varices (Gd 3 or Gd 4) at 1 year in each group. The secondary endpoint are survival,reduction in HVPG,change in CTP and MELD score& adverse events.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cirrhosis
• Liver Cirrhosis

• NCT number: NCT01196507
• Study type: Interventional
• Source: Institute of Liver and Biliary Sciences, India
• Status: Completed
• Phase: N/A
• Start date: November 2010
• Completion date: April 2014