Study of a New Anticoagulant Drug in Patients With Atrial Fibrillation

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ARYx Therapeutics

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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