Carvedilol for Pre-primary Prophylaxis of Esophageal Varices in Cirrhosis
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| ClinicalTrials.gov Identifier: NCT01212250 |
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Recruitment Status
:
Recruiting
First Posted
: September 30, 2010
Last Update Posted
: February 6, 2018
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Sponsor:
Institute of Liver and Biliary Sciences, India
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Cirrhosis | Drug: carvedilol Drug: Placebo | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 132 participants |
| 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 |
| Actual Study Start Date : | September 1, 2010 |
| Estimated Primary Completion Date : | December 1, 2018 |
| Estimated Study Completion Date : | December 1, 2018 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
North American Indian childhood cirrhosis
U.S. FDA Resources
| Arm | Intervention/treatment |
|---|---|
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Experimental: Carvedilol
Tablet 6.25 mg BD
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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.
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Placebo Comparator: placebo
Placebo tablets 2 BD
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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.
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Primary Outcome Measures
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- the proportions of patients who develop esophageal varices at 1 year in each group. [ Time Frame: 1 year ]
Secondary Outcome Measures
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- 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 ]
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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
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
| Responsible Party: | Institute of Liver and Biliary Sciences, India |
| ClinicalTrials.gov Identifier: | NCT01212250 History of Changes |
| Other Study ID Numbers: |
ILBS PHT-003 |
| First Posted: | September 30, 2010 Key Record Dates |
| Last Update Posted: | February 6, 2018 |
| Last Verified: | January 2018 |
Additional relevant MeSH terms:
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Fibrosis Liver Cirrhosis Esophageal and Gastric Varices 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 |