Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00431782
Status:
COMPLETED
Last Update Posted:
2007-11-08
First Post:
2007-02-02
Brief Title:
Study of a New Anticoagulant Drug in Patients With Atrial Fibrillation
Sponsor:
ARYx Therapeutics
Organization:
ARYx Therapeutics
Study Overview
Official Title:
An Open-Label Multi-Center Study of ATI-5923 for Anticoagulation in Patients With Atrial Fibrillation
Status:
COMPLETED
Status Verified Date:
2007-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 underover 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None