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| Name | Class |
|---|---|
| Astellas Pharma US, Inc. | INDUSTRY |
| Advanz Pharma | INDUSTRY |
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The purpose of this study is to demonstrate the safety and efficacy of RSD1235 compared to placebo in the conversion of atrial arrhythmia to sinus rhythm in subjects following valvular and/or coronary artery bypass graft surgery.
This multi-national, multi-center study is a double blind, randomized, placebo-controlled trial with 2 parallel treatment arms (1 active, 1 placebo) to assess the conversion efficacy and safety of 2 intravenous doses of RSD1235 in subjects with atrial fibrillation or atrial flutter following valvular and/or coronary artery bypass graft (CABG) surgery.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RSD1235 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of RSD1235 | 90 minutes post infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients in sinus rhythm at 90 minutes | Time from first exposure to conversion to sinus rhythm |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Astellas Pharma US, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fort Lauderdale | Florida | 33308 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19948506 | Derived | Kowey PR, Dorian P, Mitchell LB, Pratt CM, Roy D, Schwartz PJ, Sadowski J, Sobczyk D, Bochenek A, Toft E; Atrial Arrhythmia Conversion Trial Investigators. Vernakalant hydrochloride for the rapid conversion of atrial fibrillation after cardiac surgery: a randomized, double-blind, placebo-controlled trial. Circ Arrhythm Electrophysiol. 2009 Dec;2(6):652-9. doi: 10.1161/CIRCEP.109.870204. |
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| Atlanta |
| Georgia |
| United States |
| Buenos Aires | Argentina |
| La Plata | Argentina |
| Calgary | Alberta | T2N 2T9 | Canada |
| Toronto | Ontario | M5B 1W8 | Canada |
| Montreal | Quebec | H2L 4M1 | Canada |
| Montreal | Quebec | H2W 1T8 | Canada |
| Aalborg | DK | 9000 | Denmark |
| Hellerup | DK | 2900 | Denmark |
| Odense C | DK | 5000 | Denmark |
| Bangalore | 562 158 | India |
| Chennai | 600 037 | India |
| Hyderabaad | 500 001 | India |
| Kerala | 682 026 | India |
| Mohali | 160 062 | India |
| Mumbai | 400 051 | India |
| New Delhi | 110 025 | India |
| Katowice | 40-635 | Poland |
| Krakow | 31-202 | Poland |
| Lodz | 91-425 | Poland |
| Warsaw | Poland |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001282 | Atrial Flutter |
| 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 |
|---|---|
| C524581 | vernakalant |
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