Carvedilol for Pre-primary Prophylaxis of Esophageal Varices in Cirrhosis

NCT01212250 · tracked via the Priya Life Science India tracker

Sponsor

Institute of Liver and Biliary Sciences, India

Phase

Not applicable

Started

2010-09-01

Last updated

2025-08-13

Condition(s) studied

Cirrhosis

Investigational drug(s) / intervention(s)

carvedilolPlacebo

carvedilol: Carvedilol will be administered orally at a start dose of 3.125 mg twice daily. After 1 week, this will increased if systolic blood pressure does not fall below 90 mm Hg. The patient will receive the maximum tolerated dose of carvedilol with a maximum of 6.25 BD.

Placebo: The placebo tablets will be identical to the carvedilol tablets. First the patients will receive placebo in the dose of 1 BD. Then depending on his tolerance it will be increased to a maximum of 2 BD.

Study summary

Patients of cirrhosis aged 18 to 75 years who have no esophageal varices 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: * Patients of cirrhosis aged 18 to 75 years who have no esophageal or gastric varices. Exclusion Criteria: * Any contra-indication to beta-blockers * Any past EVL or sclerotherapy * Any past history of surgery for portal hypertension * Significant cardio or pulmonary co-morbidity * Any malignancy * Refusal to participate in the study

Primary outcome measure(s)

the proportions of patients who develop esophageal varices at 1 year in each group. — 1 year

Trial sites (1)

Facility	City	Region	Status
Institute of Liver & Biliary Sciences (ILBS)	New Delhi	National Capital Territory of Delhi	Recruiting

On this site

📄 Coreg (carvedilol) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01212250 on ClinicalTrials.gov ↗ ← All trials in India