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Sponsors and Collaborators: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Yale University |
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Information provided by: | Office of Rare Diseases (ORD) |
ClinicalTrials.gov Identifier: | NCT00004641 |
OBJECTIVES:
I. Evaluate the efficacy of a certain drug in preventing intestinal complications in patients with cirrhosis and high blood pressure in the hepatic portal vein. II. Evaluate vein pressure measurements to predict the development of internal bleeding.
Condition | Intervention | Phase |
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Hypertension, Portal Liver Cirrhosis Esophageal and Gastric Varices |
Drug: timolol |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Efficacy Study |
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 |
Estimated Enrollment: | 212 |
Study Start Date: | May 1993 |
Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by participating institution, cirrhosis etiology, and hepatic venous pressure gradient. The dose of oral timolol is titrated over 28 days. Patients are then randomly assigned to daily timolol at the titrated dose or a placebo if successful titration is achieved by day 28, and the final titration dose is maintained for at least 10 days. Timolol is discontinued prior to randomization. Criteria for removal from study include esophageal or gastric varices, significant bleeding or hemorrhage, timolol-induced hepatic encephalopathy, and liver transplantation. Patients are followed every 3 months.
Ages Eligible for Study: | 18 Years to 74 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Prior/Concurrent Therapy
Patient Characteristics
Study ID Numbers: | 199/11640, YALESM-6618 |
Study First Received: | February 24, 2000 |
Last Updated: | September 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00004641 History of Changes |
Health Authority: | United States: Federal Government |
Cruveilhier-Baumgarten Syndrome Esophageal Varices Gastric Varices |
Esophageal Varix Gastric Varix Alcoholic Cirrhosis |
Neurotransmitter Agents Liver Diseases Adrenergic Agents Fibrosis Gastrointestinal Diseases Vascular Diseases Cardiovascular Agents Liver Cirrhosis Hypertension, Portal Antihypertensive Agents Hepatitis Digestive System Diseases |
Varicose Veins Esophageal Disorder Portal Hypertension Esophageal and Gastric Varices Adrenergic beta-Antagonists Adrenergic Antagonists Anti-Arrhythmia Agents Timolol Esophageal Diseases Esophageal Varices Liver Cirrhosis, Alcoholic Hypertension |
Liver Diseases Neurotransmitter Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Fibrosis Physiological Effects of Drugs Liver Cirrhosis Hypertension, Portal Pathologic Processes Varicose Veins Therapeutic Uses Adrenergic beta-Antagonists |
Cardiovascular Diseases Timolol Anti-Arrhythmia Agents Vascular Diseases Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Digestive System Diseases Esophageal and Gastric Varices Adrenergic Antagonists Esophageal Diseases Hypertension |