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| ID | Type | Description | Link |
|---|---|---|---|
| Cardiome 1235-0504 |
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| Name | Class |
|---|---|
| Advanz Pharma | INDUSTRY |
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The purpose of this study is to demonstrate the effectiveness of RSD1235 compared with placebo, in the conversion of atrial fibrillation or atrial flutter to sinus rhythm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RSD1235 | Drug | IV |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| To demonstrate the efficacy of RSD1235 compared with placebo, in the conversion of atrial fibrillation or atrial flutter to sinus rhythm | Infusion plus 1.5 hours |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the time taken from exposure to first treatment to first conversion to sinus rhythm | End of study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Use Central Contact | Astellas Pharma US, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site | Birmingham | Alabama | 35213 | United States | ||
| Investigative Site |
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| placebo | Drug | IV |
|
| Huntsville |
| Alabama |
| 35801 |
| United States |
| Investigative Site | Gainesville | Florida | 32610 | United States |
| Investigative Site | Orlando | Florida | 32803 | United States |
| Investigative Site | Port Charlotte | Florida | 33952 | United States |
| Investigative Site | Indianapolis | Indiana | 46202 | United States |
| Investigative Site | Shreveport | Louisiana | 71103 | United States |
| Investigative Site | Baltimore | Maryland | 21201 | United States |
| Investigative Site | Lansing | Michigan | 48910 | United States |
| Investigative Site | Petoskey | Michigan | 49770 | United States |
| Investigative Site | Saint Paul | Minnesota | 55102 | United States |
| Investigative Site | Tupelo | Mississippi | 38801 | United States |
| Investigative Site | Holmdel | New Jersey | 07733 | United States |
| Investigative Site | Cincinnati | Ohio | 45267 | United States |
| Investigative Site | Amarillo | Texas | 79106 | United States |
| Investigative Site | Houston | Texas | 77030 | United States |
| Investigative Site | Richmond | Virginia | 23249 | United States |
| Investigative Site | Tacoma | Washington | 98405 | United States |
| Investigative Site | Marshfield | Wisconsin | 544449 | United States |
| Investigative Site | Buenos Aires | B8185XAN | Argentina |
| Investigative Site | Buenos Aires | C1039AAO | Argentina |
| Investigative Site | Buenos Aires | C1064AAR | Argentina |
| Investigative Site | Buenos Aires | C1221ADC | Argentina |
| Investigative Site | Mendoza | 5500 | Argentina |
| Investigative Site | Calgary | Alberta | T2N 2T9 | Canada |
| Investigative Site | Edmonton | Alberta | T6G 2B7 | Canada |
| Investigative Site | Halifax | Nova Scotia | B3H 1V7 | Canada |
| Investigative Site | Ottawa | Ontario | K1Y 4E9 | Canada |
| Investigative Site | Ottawa | Ontario | K1Y K1Y | Canada |
| Investigative Site | Toronto | Ontario | M5B 1W8 | Canada |
| Investigative Site | Montreal | Quebec | H1T 1C8 | Canada |
| Investigative Site | Montreal | Quebec | H2L 4M1 | Canada |
| Investigative Site | Montreal | Quebec | H2W 1T8 | Canada |
| Investigative Site | Terrebonne | Quebec | J6V 2H2 | Canada |
| Investigative Site | Santiago | Cironaria | Chile |
| Investigative Site | Aalborg | Denmark |
| Investigative Site | Arhus C | Denmark |
| Investigative Site | Esbjerg | Denmark |
| Investigative Site | Fredericia | Denmark |
| Investigative Site | Frederikssund | Denmark |
| Investigative Site | Herlev | Denmark |
| Investigative Site | Hjørring | Denmark |
| Investigative Site | Holstebro | Denmark |
| Investigative Site | Horsens | Denmark |
| Investigative Site | Hvidovre | Denmark |
| Investigative Site | København NV | Denmark |
| Investigative Site | København S | Denmark |
| Investigative Site | Køge | Denmark |
| Investigative Site | Magdalena de las Salinas | Mexico |
| Investigative Site | Malmö | Sweden |
| Investigative Site | Mölndal | Sweden |
| Investigative Site | Örebro | Sweden |
| Investigative Site | Stockholm | Sweden |
| Investigative Site | Uppsala | Sweden |
| ID | Term |
|---|---|
| D001282 | Atrial Flutter |
| 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 |
|---|---|
| C524581 | vernakalant |
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