Effects of Intravenous K201 on the Restoration of Sinus Rhythm in Subjects With Symptomatic Atrial Fibrillation

• Status: Terminated
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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 symptom score, and safety.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sequel Pharmaceuticals, Inc

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.