NCT01212250

Carvedilol for Pre-primary Prophylaxis of Esophageal Varices in Cirrhosis

A Prospective, Double-blind, Randomized Placebo-controlled Trial of Carvedilol for Pre-primary Prophylaxis of Esophageal Varices in Cirrhosis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: Institute of Liver and Biliary Sciences, India · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cirrhosis

Interventions

Type	Name	Description
DRUG	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.
DRUG	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.

Timeline

• Start date: 2010-09-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2010-09-30
• Last updated: 2025-08-13

Locations

1 site across 1 country: India