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| Sponsors and Collaborators: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Yale University |
| Information provided by: | Office of Rare Diseases (ORD) |
| ClinicalTrials.gov Identifier: | NCT00004641 |
Purpose
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 |
|
Hypertension, Portal Liver Cirrhosis Esophageal and Gastric Varices |
Drug: timolol |
Phase II |
| MedlinePlus related topics: | Cirrhosis Esophagus Disorders High Blood Pressure Varicose Veins |
| Drug Information available for: | Timolol Timolol maleate |
| 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.
Eligibility
| Ages Eligible for Study: | 18 Years to 74 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Prior/Concurrent Therapy
Patient Characteristics
Contacts and Locations
More Information
| Study ID Numbers: | 199/11640, YALESM-6618 |
| First Received: | February 24, 2000 |
| Last Updated: | September 8, 2008 |
| ClinicalTrials.gov Identifier: | NCT00004641 |
| Health Authority: | United States: Federal Government |
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