Status:
COMPLETED
Study of a New Anticoagulant Drug in Patients With Atrial Fibrillation
Lead Sponsor:
ARYx Therapeutics
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
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 a...
Eligibility Criteria
Inclusion
- Documented atrial fibrillation
- Candidate for anticoagulation or currently receiving warfarin at screening
- Males or females greater than 18 years of age
- Males or females with a CHADS2 score of 0 to 2
Exclusion
- Contraindications to anticoagulation e.g., active bleeding
- Taking other anticoagulant or antiplatelet agents other than low-dose aspirin
- History of myocardial infarction, acute coronary syndrome, or coronary revascularization procedure within the past 3 months prior to Day 1
- History of laboratory values suggestive of anemia (i.e., Hb \<10 gm/dL)
- Women of childbearing potential
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2007
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00431782
Start Date
December 1 2006
End Date
October 1 2007
Last Update
November 8 2007
Active Locations (11)
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1
ARYx Investigational Site
Anaheim, California, United States
2
ARYx Investigational Site
Yuba City, California, United States
3
ARYx Investigational Site
Deerfield Beach, Florida, United States
4
ARYx Investigational Site
Winfield, Illinois, United States