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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinique Generale Saint Jean Service de cardiologie, Brussels, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Azimilide Dihydrochloride

Drug

125 mg azimilide tablets, twice a day for 6 months

Placebo

Drug

tablets, twice daily for 6 months

Sotalol

Drug

160 mg sot twice daily for 6 months

Primary outcomes

To prolong the time to first symptomatic or asymptomatic AFIB, etc event

Time frame: 6 month

Sponsors and collaborators

Lead sponsor

Forest Laboratories

Industry

Registry information

Important dates

Study start: 2001
Primary completion: 2003
Study completion: 2003
First posted: May 6, 2002
Registry last updated: Oct 3, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed