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

Forest Laboratories

Status and phase: Completed; Phase 3

Conditions: Atrial Fibrillation

Treatments: Drug: Placebo; Drug: Azimilide Dihydrochloride; Drug: Sotalol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00035451

1999105

Details and patient eligibility

About

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.

Enrollment: 658 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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658 participants in 3 patient groups, including a placebo group

1

Placebo Comparator group

Description:

placebo tablets

Treatment:

Drug: Placebo

2

Active Comparator group

Description:

Sotalol

Treatment:

Drug: Sotalol

3

Experimental group

Description:

azimilide

Treatment:

Drug: Azimilide Dihydrochloride