Trials / Unknown
UnknownNCT00691470
Comparison of ATI-5923, a Novel Vitamin K Antagonist, With Warfarin in Patients Requiring Chronic Anticoagulation
A Randomized, Double Blind Comparison of ATI-5923, a Novel Vitamin K Antagonist, With Warfarin in Patients Requiring Chronic Anticoagulation
- Status
- Unknown
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 600 (estimated)
- Sponsor
- ARYx Therapeutics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
The primary study objective is to evaluate whether ATI-5923 is superior to adjusted dose warfarin in the quality of anticoagulation as measured by interpolated INR time in therapeutic range. This is a Phase II/III multi-center, randomized, stratified, double blind, parallel group, active control study comparing ATI-5923 with Coumadin in patients who require chronic, oral anticoagulation. Up to 600 patients who successfully complete all screening assessments and meet all eligibility criteria will be enrolled in the study and receive study drug treatment for 6-12 months depending on time of study entry.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ATI-5923 | Dose Adjusted based on INR. |
| DRUG | Coumadin (warfarin) | Dose adjusted based on INR. |
Timeline
- Start date
- 2008-05-01
- Primary completion
- 2009-06-01
- Completion
- 2009-06-01
- First posted
- 2008-06-05
- Last updated
- 2010-02-02
Locations
41 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00691470. Inclusion in this directory is not an endorsement.