Status:
COMPLETED
Phase III Tolerance and Efficacy Study of RSD1235 in Patients With Atrial Fibrillation
Lead Sponsor:
Advanz Pharma
Collaborating Sponsors:
Astellas Pharma US, Inc.
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study is being conducted to demonstrate the effectiveness of RSD1235 in the conversion of atrial fibrillation to sinus rhythm.
Detailed Description
There are approximately 2 million reported prevalent cases of atrial fibrillation (AF) and atrial flutter in the United States (Heart Disease \& Stroke Statistics - 2003 Update, AHA). These arrhythmia...
Eligibility Criteria
Inclusion
- 18 years of age or older;
- Have an atrial arrhythmia with symptoms that has been sustained for greater than 3 hours and up to 45 days.
- Have adequate anticoagulant therapy.
Exclusion
- Have a QRS \> 0.14 seconds unless patient has pacemaker or uncorrected QT \> 0.440 seconds as measured on a 12-lead ECG.
- Have serious diseases/illnesses that could interfere with the conduct or validity of the study or compromise patient safety.
- Have received intravenous Class I or Class III antiarrhythmic drugs or intravenous amiodarone within 24 hours prior to dosing.
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2004
Estimated Enrollment :
356 Patients enrolled
Trial Details
Trial ID
NCT00468767
Start Date
August 1 2003
End Date
November 1 2004
Last Update
April 2 2008
Active Locations (49)
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1
University of California
Los Angeles, California, United States, 90073
2
Regional Cardiology Associates
Sacramento, California, United States, 95819
3
Florida Heart Institute
Orlando, Florida, United States, 32803
4
James Haley VA Hospital
Tampa, Florida, United States, 33612