Double-blind, Randomized Placebo-controlled Trial of Carvedilol for Early Primary Prophylaxis of Esophageal Varices (Small_Vx)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier:
NCT01196507
First received: September 4, 2010
Last updated: August 21, 2014
Last verified: December 2013

September 4, 2010
August 21, 2014
November 2010
April 2014   (final data collection date for primary outcome measure)
The primary endpoint of the study is the the proportions of patients who develop large varices (Gd 3 or Gd 4) during the period of 1.5 year in each group. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01196507 on ClinicalTrials.gov Archive Site
  • Survival [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
  • adverse effects of drugs [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]
  • reduction in HVPG [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
  • Change in liver severity score such as CTP (Child-Turcotte-Pugh) and MELD (Model for End stage Liver Disease) [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
  • development of complications of cirrhosis (ascites, hepatic encephalopathy, SBP), [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • adverse effects of drugs [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • mortality [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Double-blind, Randomized Placebo-controlled Trial of Carvedilol for 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.

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 6.25 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 is the development of complications of cirrhosis (ascites, hepatic encephalopathy, SBP), mortality, and adverse effects of drugs

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Cirrhosis
  • 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.
  • Experimental: Carvedilol
    Tablet Carvedilol 6.25 mg BD
    Intervention: Drug: Carvedilol
  • Placebo Comparator: Placebo
    Placebo tablets 2 BD
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
April 2014
April 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

- 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.

Exclusion Criteria:

  • Any contra-indication to beta-blockers
  • Any EVL or sclerotherapy within last 3 months
  • Any past history of surgery for portal hypertension
  • Significant cardio or pulmonary co-morbidity
  • Any malignancy
  • Refusal to participate in the study
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01196507
ILBS PHT-02
No
Institute of Liver and Biliary Sciences, India
Institute of Liver and Biliary Sciences, India
Not Provided
Principal Investigator: Shiv Kumar Sarin, MBBS, MD, DM Institute of Liver & Biliary Sciences (ILBS)
Institute of Liver and Biliary Sciences, India
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP