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Carvedilol for Pre-primary Prophylaxis of Esophageal Varices in Cirrhosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by Institute of Liver and Biliary Sciences, India
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India Identifier:
First received: September 7, 2010
Last updated: February 28, 2017
Last verified: September 2016
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.

Condition Intervention
Drug: carvedilol
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Prevention
Official Title: A Prospective, Double-blind, Randomized Placebo-controlled Trial of Carvedilol for Pre-primary Prophylaxis of Esophageal Varices in Cirrhosis

Resource links provided by NLM:

Further study details as provided by Institute of Liver and Biliary Sciences, India:

Primary Outcome Measures:
  • the proportions of patients who develop esophageal varices at 1 year in each group. [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Number of patient dying in a period of one year [ Time Frame: 1 year ]
  • Number of patients needing discontinuation of therapy due to adverse effects. [ Time Frame: 1 year ]
  • Reduction in Hepatic Venous Pressure Gradient in both groups [ Time Frame: 1 year ]

Estimated Enrollment: 132
Study Start Date: September 2010
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Carvedilol
Tablet 6.25 mg BD
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.
Placebo Comparator: placebo
Placebo tablets 2 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.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01212250

Contact: Ankur Jindal, DM 011-46300000

Institute of Liver & Biliary Sciences (ILBS) Recruiting
New Delhi, Delhi, India
Contact: Ankur Jindal, DM    9582670984   
Principal Investigator: Ankur Jindal, MBBS, MD, DM         
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India
  More Information

Responsible Party: Institute of Liver and Biliary Sciences, India Identifier: NCT01212250     History of Changes
Other Study ID Numbers: ILBS PHT-003
Study First Received: September 7, 2010
Last Updated: February 28, 2017

Additional relevant MeSH terms:
Liver Cirrhosis
Esophageal and Gastric Varices
Pathologic Processes
Liver Diseases
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Hypertension, Portal
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists processed this record on May 25, 2017