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Sponsored by: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00006398 |
The purpose of this study is to learn whether timolol is useful in preventing or delaying the appearance of gastroesophageal varices, a complication that may develop in the future as a consequence of liver disease. Cirrhosis causes an increased resistance of blood flowing through the liver. This leads to an increased pressure in the portal vein (the vein that takes blood to your liver). High portal pressure is responsible for the appearance of complications of chronic liver disease such as varices and variceal bleeding (bleeding from veins in your esophagus). Timolol belongs to a group of medications called beta-blockers. Beta-blockers decrease high portal pressure and previous studies have shown that beta-blocker pills are useful in preventing bleeding from varices in patients who already have varices. A more desirable effect would be if these pills could prevent not only bleeding from varices but the appearance of varices (and therefore of bleeding).
Condition | Intervention | Phase |
---|---|---|
Esophageal and Gastric Varices Liver Cirrhosis Portal Hypertension |
Drug: Timolol Maleate |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Double-Blind |
Official Title: | Randomized, Double-Blind Study of Timolol (A Nonselective Beta-Adrenergic Blocker) Vs Placebo to Prevent Complications of Hepatic Portal Hypertension in Patients With Cirrhosis |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Connecticut | |
VA CT Healthcare System | |
West Haven, Connecticut, United States, 06516 | |
Yale University Sch. of Medicine | |
New Haven, Connecticut, United States, 06520 | |
United States, Massachusetts | |
The Faulkner Hospital | |
Boston, Massachusetts, United States, 02130 | |
Spain, Catalonia | |
Hospital Clinic I Provincial de Barcelona | |
Barcelona, Catalonia, Spain | |
United Kingdom, London | |
Royal Free Hospital | |
Hampstead, London, United Kingdom, NW32QG |
Principal Investigator: | Roberto J Groszmann, M.D. | Yale University School of Med. |
Investigator: | Norman Grace, M.D. | Tufts University |
Investigator: | Jaime Bosch, M.D. | University of Barcelona |
Investigator: | Andrew Burroughs, M.D. | University of London |
Investigator: | Guadalupe Garcia-Tsao, M.D. | Yale University |
Study ID Numbers: | Timolol, RO1 DK46580, YALESM, 6618 |
Study First Received: | October 5, 2000 |
Last Updated: | May 4, 2006 |
ClinicalTrials.gov Identifier: | NCT00006398 |
Health Authority: | United States: Federal Government |
cirrhosis esophageal varices variceal hemorrhage beta-adrenergic blocker |
Liver Diseases Esophageal disorder Fibrosis Gastrointestinal Diseases Vascular Diseases Liver Cirrhosis Hypertension, Portal Hemorrhage |
Portal hypertension Esophageal varices Digestive System Diseases Varicose Veins Esophageal and Gastric Varices Timolol Esophageal Diseases Hypertension |
Neurotransmitter Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |
Pathologic Processes Therapeutic Uses Adrenergic beta-Antagonists Cardiovascular Diseases Adrenergic Antagonists Anti-Arrhythmia Agents |