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Carvedilol for Pre-primary Prophylaxis of Esophageal Varices in Cirrhosis

This study is currently recruiting participants.
Verified September 2016 by Institute of Liver and Biliary Sciences, India
Sponsor:
ClinicalTrials.gov Identifier:
NCT01212250
First Posted: September 30, 2010
Last Update Posted: March 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India
  Purpose
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
Cirrhosis Drug: carvedilol Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01212250


Contacts
Contact: Ankur Jindal, DM 011-46300000 ankur.jindal3@gmail.com

Locations
India
Institute of Liver & Biliary Sciences (ILBS) Recruiting
New Delhi, Delhi, India
Contact: Ankur Jindal, DM    9582670984    ankur.jindal3@gmail.com   
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
ClinicalTrials.gov Identifier: NCT01212250     History of Changes
Other Study ID Numbers: ILBS PHT-003
First Submitted: September 7, 2010
First Posted: September 30, 2010
Last Update Posted: March 1, 2017
Last Verified: September 2016

Additional relevant MeSH terms:
Esophageal and Gastric Varices
Fibrosis
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Hypertension, Portal
Carvedilol
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


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