Efficacy and Safety Evaluation of Azimilide or Sotalol vs Placebo for Treatment of Patients With Atrial Fibrillation.
Status:
Completed
Trial end date:
2003-06-01
Target enrollment:
Participant gender:
Summary
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.