Trial | NCT01212250  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    carvedilol ...

  • Study Participants

    132
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.
Study Started
Sep 01
2010
Primary Completion
Dec 01
2020
Anticipated
Study Completion
Dec 01
2020
Anticipated
Last Update
Nov 05
2019

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.

Carvedilol Experimental

Tablet 6.25 mg BD

placebo Placebo Comparator

Placebo tablets 2 BD

Criteria 

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
No Results Posted