Status:
TERMINATED
Effects of Intravenous K201 on the Restoration of Sinus Rhythm in Subjects With Symptomatic Atrial Fibrillation
Lead Sponsor:
Sequel Pharmaceuticals, Inc
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the effects of a single intravenous infusion of K201 compared to placebo in a dose escalating manner on conversion to sinus rhythm, reduction of subject's symp...
Eligibility Criteria
Inclusion
- Symptomatic atrial fibrillation for more than 3 hours and less than 7 days (as dated by symptoms).
- Atrial fibrillation documented by ECG at the start of study drug infusion.
Exclusion
- Previous exposure to K201
- QTcF (Fridericia correction) \>440 ms
- QRS interval \> 140 ms
- Paced atrial or paced ventricular rhythm on ECG
- History of receiving another intravenous Class I or Class III antiarrhythmic drug within 3 days of randomization
- History of amiodarone (oral or IV) in the last 3 months.
- Clinical evidence or history of acute coronary syndrome (e.g. myocardial infarction, unstable angina) within 30 days prior to randomization
- History of failed electrical cardioversion at any time in the past
- History of polymorphic ventricular tachycardia (e.g. torsades des pointes)
- History or family history of Long QT Syndrome
- History of ventricular tachycardia requiring drug or device therapy
- Ejection fraction of 40% or less.
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2011
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01259622
Start Date
February 1 2011
End Date
December 1 2011
Last Update
May 16 2011
Active Locations (17)
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1
Copenhagen, Denmark
2
Esbjerg, Denmark
3
Glostrup Municipality, Denmark
4
Haderslev, Denmark