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Carvedilol for Pre-primary Prophylaxis of Esophageal Varices in Cirrhosis
Sponsor: Institute of Liver and Biliary Sciences, India
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.
Official title: A Prospective, Double-blind, Randomized Placebo-controlled Trial of Carvedilol for Pre-primary Prophylaxis of Esophageal Varices in Cirrhosis
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
132
Start Date
2010-09-01
Completion Date
2026-12-31
Last Updated
2025-08-13
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
Institute of Liver & Biliary Sciences (ILBS)
New Delhi, National Capital Territory of Delhi, India