Efficacy and Safety Evaluation of Azimilide or Sotalol vs Placebo for Treatment of Patients With Atrial Fibrillation.
Efficacy and Safety Evaluation of Azimilide or Sotalol vs Placebo for Treatment of Patients With Atrial Fibrillation.
Atrial fibrillation (abnormal rhythm in the upper chamber of the heart) is a common
 supraventricular arrhythmia (a type of abnormal heart rhythm) for which antiarrhythmic
 therapy is often prescribed. The primary goals of therapy are to maintain sinus rhythm
 (normal heart rhythm) and to reduce the occurrence of episodes of atrial fibrillation.

 The double-blind, placebo-controlled phase of this study is designed to evaluate the efficacy
 and safety of oral azimilide compared with placebo and with sotalol, an antiarrhythmic drug,
 in maintaining sinus rhythm in patients who require cardioversion (electric shock to correct
 heart rhythm) to correct atrial fibrillation. Once this phase of the study is completed, a
 second phase with a different study design will be conducted. The second phase is an
 open-label, follow-up phase to the first study. The follow-up phase will continue to evaluate
 the long-term safety of a daily oral dose of azimilide in patients who complete the
 double-blind, placebo-controlled phase of this study.
Inclusion criteria:

 -  Documented (12-lead ECG) history of symptomatic atrial fibrillation occurring between
 48 hours and 6 months before screening

 -  Require the procedure of cardioversion (electric shock to correct abnormal rhythm)

 -  In the investigator's opinion, is likely to maintain sinus rhythm after cardioversion.

 -  Be anticoagulated according to the recommendations of the Study Group on Atrial
 Fibrillation of the European Society of Cardiology guidelines.

 Exclusion criteria:

 -  Previously unsuccessful electrical cardioversions

 -  Failed to respond to any Class III antiarrhythmic drugs

 -  Qualifying arrhythmia due to acute reversible illness, acute myocardial infarction,
 and/or cardiac or thoracic surgery within one month prior to randomization