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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
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier:
NCT01212250
First received: September 7, 2010
Last updated: September 26, 2016
Last verified: September 2016

September 7, 2010
September 26, 2016
September 2010
December 2016   (final data collection date for primary outcome measure)
the proportions of patients who develop esophageal varices at 1 year in each group. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01212250 on ClinicalTrials.gov Archive Site
  • Number of patient dying in a period of one year [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Number of patients needing discontinuation of therapy due to adverse effects. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Reduction in Hepatic Venous Pressure Gradient in both groups [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • complications of cirrhosis (ascites, hepatic encephalopathy, SBP), [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Number of patient dying in a period of one year [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Number of patients needing discontinuation of therapy due to adverse effects. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
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Not Provided
 
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
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.
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 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.
 
Recruiting
132
December 2016
December 2016   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years   (Adult, Senior)
No
Contact: Ankur Jindal, DM 011-46300000 ankur.jindal3@gmail.com
India
 
NCT01212250
ILBS PHT-003
No
Not Provided
Not Provided
Institute of Liver and Biliary Sciences, India
Institute of Liver and Biliary Sciences, India
Not Provided
Not Provided
Institute of Liver and Biliary Sciences, India
September 2016

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