Status:
COMPLETED
Study to Determine the Response and Effectiveness of RSD1235 in Subjects With Atrial Fibrillation or Atrial Flutter
Lead Sponsor:
Astellas Pharma Inc
Collaborating Sponsors:
Advanz Pharma
Conditions:
Atrial Flutter
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- Atrial flutter or atrial fibrillation that has been sustained for greater than 3 hours and up to 45 days
Exclusion
- Myocardial infarction, acute coronary syndrome or cardiac surgery within 30 days prior to randomization
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2005
Estimated Enrollment :
276 Patients enrolled
Trial Details
Trial ID
NCT00115791
Start Date
June 1 2004
End Date
June 1 2005
Last Update
April 1 2008
Active Locations (54)
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1
Investigative Site
Birmingham, Alabama, United States, 35213
2
Investigative Site
Huntsville, Alabama, United States, 35801
3
Investigative Site
Gainesville, Florida, United States, 32610
4
Investigative Site
Orlando, Florida, United States, 32803