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

Phase 3

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: Placebo; Drug: Sotalol; Drug: Azimilide Dihydrochloride

• Registration Number: NCT00035451
• Lead Sponsor: Forest Laboratories

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-02
• Study First Submitted: 2002-05-03
• Study First Submitted QC: 2002-05-03
• Study First Posted: 2002-05-06
• Primary Completion: 2003-06
• Study Completion: 2003-06
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-30
• Last Update Posted: 2011-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 658

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Placebo	placebo tablets
2	Sotalol	Sotalol
3	Azimilide Dihydrochloride	azimilide

Primary Outcome Measures

Name	Time	Method
To prolong the time to first symptomatic or asymptomatic AFIB, etc event	6 month

Trial Locations

Locations (129)

Clinique Generale Saint Jean Service de cardiologie; 🇧🇪 Brussels, Belgium

Hospital Universitarie Erasme; 🇧🇪 Brussels, Belgium

Cliniques Univeristaires UCL Mont-Godinne Avenue Theresse 1; 🇧🇪 Yvoir, Belgium

Service de Cardilolgie CH du Pays d'Aix; 🇫🇷 Aix-En-Provence, France

CHR Besancon Service de cardiologie; 🇫🇷 Besancon, France

Hopital Gavriel Montpied Cardiologie-Maladie cardiovascularies; 🇫🇷 Clermont-Ferrand, France

Service de Cardiologie CHRU; 🇫🇷 Grenoble, France

Cardiologie Hopital Jean Rostand; 🇫🇷 Ivry-Sur-Seine, France

Service de Cardiologie A Hopital Cardiologique; 🇫🇷 Lille, France

Service de Cardiologie Hopital Saint Philibert; 🇫🇷 Lomme, France

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