Double-blind, Randomized Placebo-controlled Trial of Carvedilol for Early Primary Prophylaxis of Esophageal Varices (Small_Vx)
This study is currently recruiting participants.
Verified March 2013 by Institute of Liver and Biliary Sciences, India
Sponsor:
Institute of Liver and Biliary Sciences, India
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier:
NCT01196507
First received: September 4, 2010
Last updated: March 25, 2013
Last verified: March 2013
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Purpose
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
| Condition | Intervention |
|---|---|
|
Cirrhosis |
Drug: Carvedilol Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | A Prospective, Double-blind, Randomized Placebo-controlled Trial of Carvedilol for Early Primary Prophylaxis of Esophageal Varices in Cirrhosis. |
Resource links provided by NLM:
Genetics Home Reference related topics:
North American Indian childhood cirrhosis
Drug Information available for:
Carvedilol
U.S. FDA Resources
Further study details as provided by Institute of Liver and Biliary Sciences, India:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
- Transplantation [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 132 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Carvedilol
Tablet Carvedilol 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| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01196507
Contacts
| Contact: Chitranshu Vashishtha, DM | +91-9540951042 | chitranshuv@hotmail.com, |
| Contact: Ankit Bhardwaj | +91-9717270640 | bhardwaj.ankit3@gmail.com |
Locations
| India | |
| Institute of Liver & Biliary Sciences (ILBS) | Recruiting |
| New Delhi, Delhi, India, 110 070 | |
| Contact: Chitranshu Vashishtha, DM +91-9540951042 chitranshuv@hotmail.com, | |
| Contact: Ankit Bhardwaj +91-9717270640 bhardwaj.ankit3@gmail.com | |
| Principal Investigator: Chitranshu Vashishtha, MBBS, MD, DM | |
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India
Investigators
| Principal Investigator: | Chitranshu Vashishtha, MBBS, MD, DM | Institute of Liver & Biliary Sciences (ILBS) |
More Information
No publications provided
| Responsible Party: | Institute of Liver and Biliary Sciences, India |
| ClinicalTrials.gov Identifier: | NCT01196507 History of Changes |
| Other Study ID Numbers: | ILBS PHT-02 |
| Study First Received: | September 4, 2010 |
| Last Updated: | March 25, 2013 |
| Health Authority: | India: Ministry of Health |
Additional relevant MeSH terms:
|
Esophageal and Gastric Varices Liver Cirrhosis Fibrosis Varicose Veins Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Hypertension, Portal Liver Diseases Pathologic Processes Vascular Diseases Cardiovascular Diseases Carvedilol |
Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Vasodilator Agents Adrenergic alpha-1 Receptor Antagonists Adrenergic alpha-Antagonists |
ClinicalTrials.gov processed this record on May 16, 2013