Status:
COMPLETED
Response to RSD1235 Compared to Placebo in Subjects With Atrial Arrhythmia After Heart Surgery
Lead Sponsor:
Astellas Pharma Inc
Collaborating Sponsors:
Astellas Pharma US, Inc.
Advanz Pharma
Conditions:
Atrial Fibrillation
Atrial Flutter
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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...
Detailed Description
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 i...
Eligibility Criteria
Inclusion
- Documented atrial arrhythmia after valvular and/or coronary artery bypass graft surgery
Exclusion
- Unstable Class IV heart failure
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT00125320
Start Date
June 1 2004
End Date
February 1 2007
Last Update
December 24 2007
Active Locations (22)
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1
Fort Lauderdale, Florida, United States, 33308
2
Atlanta, Georgia, United States
3
Buenos Aires, Argentina
4
La Plata, Argentina