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The purpose of this study is to determine the safety and efficacy of an investigational antiarrhythmic drug (ATI-2042) in the treatment of atrial fibrillation in patients with a dual chamber pacemaker.
ATI-2042 is being developed as an alternative to amiodarone, which is considered a first-line therapy for patients with atrial fibrillation and is known to have serious side effects. ATI-2042 was designed to have a reduced plasma half-life and a lower volume of distribution, which is expected to result in an improved safety profile. In contrast to amiodarone, ATI-2042 undergoes rapid metabolism via plasma and tissue esterases, which may reduce tissue accumulation and toxicity. The current trial will determine if ATI-2042 retains the efficacy profile of amiodarone without the side effects attributable to tissue accumulation seen with long-term dosing.
This study is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants.)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ATI-2042 200 mg | No Intervention |
| |
| ATI-2042 400 mg | No Intervention |
| |
| ATI-2042 600 mg | No Intervention |
| |
| ATI-2042 Placebo | No Intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATI-2042 | Drug | no intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy Measure: Atrial Fibrillation Burden | ||
| Safety Measures: ECG, Laboratory and Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Ezekowitz, MBChB, PhD | Main Line Health | Study Chair |
| Olga Bandman, MD | ARYx Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ARYx Investigational Site | Phoenix | Arizona | 85306 | United States | ||
| ARYx Investigational Site |
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| ATI-2042 200 mg | Drug | To stop the dosing of ATI-2042 for a designated time frame as determined by the medical monitor and Principal Investigator. |
|
| Scottsdale |
| Arizona |
| 85251 |
| United States |
| ARYx Investigational Site | Tucson | Arizona | 85715 | United States |
| ARYx Investigational Site | Larkspur | California | 94939 | United States |
| ARYx Investigational Site | Aurora | Colorado | 80012 | United States |
| ARYx Investigational Site | Hollywood | Florida | 33021 | United States |
| ARYx Investigational Site | Jacksonville Beach | Florida | 32250 | United States |
| ARYx Investigational Site | Atlanta | Georgia | 30309 | United States |
| ARYx Investigational Site | Marietta | Georgia | 30060 | United States |
| ARYx Investigational Site | Chicago | Illinois | 60611 | United States |
| ARYx Investigational Site | Towson | Maryland | 21204 | United States |
| ARYx Investigational Site | Saginaw | Michigan | 48601 | United States |
| ARYx Investigational Site | Minneapolis | Minnesota | 55442 | United States |
| ARYx Investigational Site | St Louis | Missouri | 63110 | United States |
| ARYx Investigational Site | Lincoln | Nebraska | 68506 | United States |
| ARYx Investigational Site | Warren Township | New Jersey | 07059 | United States |
| ARYx Investigational Site | Albuquerque | New Mexico | 87102 | United States |
| ARYx Investigational Site | Buffalo | New York | 14215 | United States |
| ARYx Investigational Site | Hershey | Pennsylvania | 17033 | United States |
| ARYx Investigational Site | Wynnewood | Pennsylvania | 19096 | United States |
| ARYx Investigational Site | Charleston | South Carolina | 29425 | United States |
| ARYx Investigational Site | Nashville | Tennessee | 37203 | United States |
| ARYx Investigational Site | Austin | Texas | 78756 | United States |
| ARYx Investigational Site | Houston | Texas | 77030 | United States |
| ARYx Investigational Site | Burlington | Vermont | 05401 | United States |
| ARYx Investigational Site | Newport News | Virginia | 23601 | United States |
| ARYx Investigational Site | Charleston | West Virginia | 25304 | United States |
| ARYx Investigational Site | Edmonton | Alberta | T6G 2B7 | Canada |
| ARYx Investigational Site | Edmonton | Alberta | T6K4C1 | Canada |
| ARYx Investigational Site | Campbell River | British Columbia | V9W3V1 | Canada |
| ARYx Investigational Site | Vancouver | British Columbia | V6Z1Y6 | Canada |
| ARYx Investigational Site | Victoria | British Columbia | V8R 4R2 | Canada |
| ARYx Investigational Site | London | Ontario | N6A 5A5 | Canada |
| ARYx Investigational Site | Niagara Falls | Ontario | L2E 7H1 | Canada |
| ARYx Investigational Site | Ottawa | Ontario | K1Y 4W7 | Canada |
| ARYx Investigational Site | Montreal | Quebec | H1T 1C8 | Canada |
| ARYx Investigational Site | Montreal | Quebec | H2L 4M1 | Canada |
| ARYx Investigational Sites | Montreal | Quebec | H4J1C5 | Canada |
| ARYx Investigational Site | Sherbrooke | Quebec | J1H5N4 | Canada |
| ARYx Investigational Site | Terrebonne | Quebec | J6V 2H2 | Canada |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C499879 | celivarone |
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