drugset / Trial / NCT00691470

Comparison of ATI-5923, a Novel Vitamin K Antagonist, With Warfarin in Patients Requiring Chronic Anticoagulation

NCT00691470

Phase 2/3 Unknown 600 enrolled ARYx Therapeutics
RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this research study is to test an experimental drug ATI-5923 vs Coumadin. The study is intended to demonstrate ATI-5923 is superior to Coumadin for keeping INR values in the desired therapeutic range. Patients who require chronic anticoagulation with one or more of the following conditions are eligible for the study: atrial fibrillation or atrial flutter, prosthetic heart valve, venous thromboembolic disease, or history of myocardial infarction or cardiomyopathy will be enrolled.

Timeline

Start
2008-05
Primary completion
2009-06
Completion
2009-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Tecarfarin Small molecule Oral
Comparator Warfarin Small molecule Oral