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Sponsored by: |
ARYx Therapeutics |
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Information provided by: | ARYx Therapeutics |
ClinicalTrials.gov Identifier: | NCT00431782 |
The primary purpose of this study (CLN-504) is to determine the safety and develop a dosing regimen of an investigational anticoagulant drug (ATI-5923) in patients with atrial fibrillation.
Condition | Intervention | Phase |
---|---|---|
Atrial Fibrillation |
Drug: ATI-5923 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label Multi-Center Study of ATI-5923 for Anticoagulation in Patients With Atrial Fibrillation |
Estimated Enrollment: | 60 |
Study Start Date: | December 2006 |
Study Completion Date: | October 2007 |
ATI-5923 is a structural analog of warfarin that is being developed as an oral anticoagulant. It has a similar pharmacological profile to warfarin but was designed to provide more uniform and stable anticoagulation. ATI-5923 is a selective, non-competitive inhibitor of vitamin K epoxide reductase.
ATI-5923 is metabolized by esterase to a single inactive metabolite and thus is expected to have less variable metabolism, drug-drug interactions and reduced instances of under/over coagulation, making the response safer and more predictable. The primary purpose of this study is to develop a dosing regimen and INR monitoring schedule that can be applied in an outpatient setting to safely and conveniently anticoagulate patients with atrial fibrillation to a therapeutic INR. Patients with atrial fibrillation (AF) were chosen for the study population of this trial because they require anticoagulation if they have risk factors for stroke.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
ARYx Investigational Site | |
Yuba City, California, United States | |
ARYx Investigational Site | |
Anaheim, California, United States | |
United States, Florida | |
ARYx Investigational Site | |
Deerfield Beach, Florida, United States | |
United States, Illinois | |
ARYx Investigational Site | |
Winfield, Illinois, United States | |
United States, Oklahoma | |
ARYx Investigational Site | |
Oklahoma City, Oklahoma, United States | |
United States, Pennsylvania | |
ARYx Investigational Site | |
Wynnewood, Pennsylvania, United States | |
ARYx Investigational Site | |
Wellsboro, Pennsylvania, United States | |
United States, South Carolina | |
ARYx Investigational Site | |
Greer, South Carolina, United States | |
ARYx Investigational Site | |
Spartanburg, South Carolina, United States | |
United States, Tennessee | |
ARYx Investigational Site | |
Memphis, Tennessee, United States | |
United States, Texas | |
ARYx Investigational Site | |
San Antonio, Texas, United States |
Study Director: | Dave Ellis, M.D., Ph.D | ARYx Therapeutics |
Study ID Numbers: | ATI-5923-CLN-504 |
Study First Received: | February 2, 2007 |
Last Updated: | November 7, 2007 |
ClinicalTrials.gov Identifier: | NCT00431782 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Atrial fibrillation Anticoagulation |
Anticoagulants Heart Diseases Atrial Fibrillation Arrhythmias, Cardiac |
Anticoagulants Pathologic Processes Heart Diseases Therapeutic Uses Hematologic Agents |
Cardiovascular Diseases Atrial Fibrillation Pharmacologic Actions Arrhythmias, Cardiac |