NCT01196507

Early Primary Prophylaxis of Esophageal Varices

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (actual)
• 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 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.

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 or with a maximum of 12.5 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 4 BD.

Timeline

• Start date: 2010-11-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2010-09-08
• Last updated: 2016-06-15

Locations

1 site across 1 country: India