Atrial Fibrillation Clinical Trial
Official title:
A Phase 3, Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Tolerance and Efficacy Study of RSD1235 in Subjects With Atrial Fibrillation or Atrial Flutter
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.
| Status | Completed |
| Enrollment | 276 |
| Est. completion date | June 2005 |
| Est. primary completion date | June 2005 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Atrial flutter or atrial fibrillation that has been sustained for greater than 3 hours and up to 45 days Exclusion Criteria: - Myocardial infarction, acute coronary syndrome or cardiac surgery within 30 days prior to randomization |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Investigative Site | Buenos Aires | |
| Argentina | Investigative Site | Buenos Aires | |
| Argentina | Investigative Site | Buenos Aires | |
| Argentina | Investigative Site | Buenos Aires | |
| Argentina | Investigative Site | Mendoza | |
| Canada | Investigative Site | Calgary | Alberta |
| Canada | Investigative Site | Edmonton | Alberta |
| Canada | Investigative Site | Halifax | Nova Scotia |
| Canada | Investigative Site | Montreal | Quebec |
| Canada | Investigative Site | Montreal | Quebec |
| Canada | Investigative Site | Montreal | Quebec |
| Canada | Investigative Site | Ottawa | Ontario |
| Canada | Investigative Site | Ottawa | Ontario |
| Canada | Investigative Site | Terrebonne | Quebec |
| Canada | Investigative Site | Toronto | Ontario |
| Chile | Investigative Site | Santiago | Cironaria |
| Denmark | 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 | Hjorring | |
| Denmark | Investigative Site | Holstebro | |
| Denmark | Investigative Site | Horsens | |
| Denmark | Investigative Site | Hvidovre | |
| Denmark | Investigative Site | Kobenhavn NV | |
| Denmark | Investigative Site | Kobenhavn S | |
| Denmark | Investigative Site | Koge | |
| Mexico | Investigative Site | Magdalena de las Salinas | |
| Sweden | Investigative Site | Malmo | |
| Sweden | Investigative Site | Molndal | |
| Sweden | Investigative Site | Orebro | |
| Sweden | Investigative Site | Stockholm | |
| Sweden | Investigative Site | Uppsala | |
| United States | Investigative Site | Amarillo | Texas |
| United States | Investigative Site | Baltimore | Maryland |
| United States | Investigative Site | Birmingham | Alabama |
| United States | Investigative Site | Cincinnati | Ohio |
| United States | Investigative Site | Gainesville | Florida |
| United States | Investigative Site | Holmdel | New Jersey |
| United States | Investigative Site | Houston | Texas |
| United States | Investigative Site | Huntsville | Alabama |
| United States | Investigative Site | Indianapolis | Indiana |
| United States | Investigative Site | Lansing | Michigan |
| United States | Investigative Site | Marshfield | Wisconsin |
| United States | Investigative Site | Orlando | Florida |
| United States | Investigative Site | Petoskey | Michigan |
| United States | Investigative Site | Port Charlotte | Florida |
| United States | Investigative Site | Richmond | Virginia |
| United States | Investigative Site | Shreveport | Louisiana |
| United States | Investigative Site | St. Paul | Minnesota |
| United States | Investigative Site | Tacoma | Washington |
| United States | Investigative Site | Tupelo | Mississippi |
| Lead Sponsor | Collaborator |
|---|---|
| Astellas Pharma Inc | Cardiome Pharma |
United States, Argentina, Canada, Chile, Denmark, Mexico, Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No | |
| Secondary | To assess the time taken from exposure to first treatment to first conversion to sinus rhythm | End of study | No |
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