Efficacy and Safety Evaluation of Azimilide or Sotalol vs Placebo for Treatment of Patients With Atrial Fibrillation.

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy and Safety Evaluation of Azimilide or Sotalol vs Placebo for Treatment of Patients With Atrial Fibrillation.

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Drug: Azimilide Dihydrochloride
* Drug: Placebo
* Drug: Sotalol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>placebo tablets | Drug: Placebo<br>* tablets, twice daily for 6 months<br>|
| Active Comparator: 2<br>Sotalol | Drug: Sotalol<br>* 160 mg sot twice daily for 6 months<br>|
| Experimental: 3<br>azimilide | Drug: Azimilide Dihydrochloride<br>* 125 mg azimilide tablets, twice a day for 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To prolong the time to first symptomatic or asymptomatic AFIB, etc event |  | 6 month |