Atrial Fibrillation Clinical Trial
Official title:
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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