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)

Cardiologie A CHU Rangueil; 🇫🇷 Toulouse, France

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

CHR Besancon Service de cardiologie; 🇫🇷 Besancon, France

Kerckhhoff-Klinik Abteilung Klinische Pharmakologie; 🇩🇪 Bad Nauheim, Germany

Medizinische Universitats-und Ploiklinik Innere Medizin 3; 🇩🇪 Homburg, Germany

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

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

Klinikum Coburg II Med. Klinik; 🇩🇪 Coburg, Germany

Medizinische Universitat Tubingen Med. Klinik III, Abt. III fur Kardiologie; 🇩🇪 Tuebingen, Germany

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

Markoth Ferenc County Hospital; 🇭🇺 Eger, Hungary

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

Hospital Universitarie Erasme; 🇧🇪 Brussels, Belgium

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

Dr. Schreiber Krankenhaus Neukoelin 1 Innere Rudowerstrasse, 48; 🇩🇪 Berlin, Germany

Klinik am See REHA-Zentrum fur Herz und Kreislauf; 🇩🇪 Ruedersdorf, Germany

Reinhard-Nieter-Krankenhaus Med. Klinik 1; 🇩🇪 Wilhelmshafen, Germany

Azienda Ospedaliera "Garibaldi S, Luigi Ascoli Tomaselli" Servizio di Cardiologia; 🇮🇹 Catania, Italy

Klinkum Lippe-Detmold Med. Klink II-Kardiologie; 🇩🇪 Detmold, Germany

Cardiologie CHRU St Etienne/Hopital Nord; 🇫🇷 Saint-Etienne, France

Kardiologie Herzzentrum Osnabruck; 🇩🇪 Bad Rothenfelde, Germany

Krankenhaus Duren Medizinische Klinik I Kardiologie/Angiologie; 🇩🇪 Dueren, Germany

Service de Cardiologie CHRU; 🇫🇷 Grenoble, France

Cardilolgie Hopital Guillaume et Rene Laennec; 🇫🇷 Nantes, France

Divisione di Cardiologia Ospedale Civile; 🇮🇹 Asti, Italy

Ospedale Civile Umberto I Cardiology Division; 🇮🇹 Mestre, Italy

Medizinische Klinik und Poliklinik Innere Medizin C; 🇩🇪 Munster, Germany

Hospital Universitari San Juan Servicio di Cardiologia; 🇪🇸 Alicante, Spain

Universitate zu Koeln Klinik III fur Innere Medizin; 🇩🇪 Koeln (Lindenthal), Germany

Cardiology Department, Moscow Clinical Hospital No. 59; 🇷🇺 Moscow, Russian Federation

Medical Centre of General Management Department of the President of the Russian Federation, Cardiology Department Moscow Clinical Hospital No. 51; 🇷🇺 Moscow, Russian Federation

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

Medizinische Hochschule Innere Medizin/Abt. fur Kardiologie; 🇩🇪 Hannover, Germany

Erzgebirgskrankenhaus Klinik fur Innere Medizin; 🇩🇪 Annaberg, Germany

Stadisches Klinikum Brandenburg Med-Klinik I/Kardiologie Pulmologie und Angiologie; 🇩🇪 Brandenburg, Germany

Universitatsklinikum Hamburg-Eppendork Klinik und Poliklinik fur Innere Medizin Abteilung Kardiologie; 🇩🇪 Hamburg, Germany

Medizinische Universitaetsklinik Innere Medizin III Kardiologie und Angiologie; 🇩🇪 Frieburg, Germany

Service de cardiologie Hopitaux de Brabois/CHRU Nancy; 🇫🇷 Vandoeuvre les Nancy, France

Klinikum Erfurt GmbH; 🇩🇪 Erfurt, Germany

Academisch Ziekenhuis Maastricht Afdeling Cardiologie; 🇳🇱 Maastricht, Netherlands

Servizio di Cardiologia Azienda Ospedaliera S. Anna; 🇮🇹 Como, Italy

Cardiology Division Hospital "Santa Croce e Carle"; 🇮🇹 Cuneo, Italy

S. Paolo Hospital University of Milan Department of Cardiology; 🇮🇹 Milano, Italy

Cardiology Unit Policlinico S. Matteo; 🇮🇹 Pavia, Italy

Semmelweis University, Dept. of Internal Medicine III.; 🇭🇺 Budapest, Hungary

Department of Internal Medicine (DIMI) University of Genova; 🇮🇹 Genova, Italy

Cardiology Unit University of Naples "Frederico II"; 🇮🇹 Napoli, Italy

Myocardial Infarction Department St Petersburg Hospital, No. 28; 🇷🇺 St Petersburg, Russian Federation

Russian State Medical University Clinical facility: Cardiology Department of City Clinical Hospital No. 4; 🇷🇺 Moscow, Russian Federation

Kennemer Gasthuis; 🇳🇱 Haarlem, Netherlands

Isala Klinieken Locatie De Weezenlanden; 🇳🇱 JW Zwolle, Netherlands

Department Cardiology Canisius Wilhelmina Hospital; 🇳🇱 Nijmegen, Netherlands

St Elisabeth Ziekenhuis Afdeling Cardiologie; 🇳🇱 Tilburg, Netherlands

Samodzielny Publiczny Szpital Zespolony Oddizial Kardiologii; 🇵🇱 Szczecin, Poland

Oddzial Kardiologii Szpital Wojewodzki; 🇵🇱 Zamosc, Poland

Cardiovascular Disease Unit University of Bari-Ploiclinico; 🇮🇹 Bari, Italy

Osp. Civile di Piacenza-Div. di Cardiologia; 🇮🇹 Piacenza, Italy

Service de Cardiologie Hopital Lariboisiere; 🇫🇷 Paris, France

Service de Cardiologie et Maladies Vascularies CHRU Pontchaillou; 🇫🇷 Rennes, France

Cardiologie/Pavillon Baudot Centre Hospitalier Universitaire Purpan; 🇫🇷 Toulouse, France

Centre Hospitalier General Hospital De Girac; 🇫🇷 St Michel, France

Department of Emergency Cardiology Russian Cardiology Research Centre; 🇷🇺 Moscow, Russian Federation

Cardiology Department, State Research Institute; 🇷🇺 St Petersburg, Russian Federation

Cardiology Department Moscow Sechenov Medical Academy; 🇷🇺 Moscow, Russian Federation

Cardiology Department of State Medical Academy of Postgraduate Education, Myasnikov Clinical Cardiology Research Institute; 🇷🇺 Moscow, Russian Federation

Medical Centre of General Management Department of the President of the Russian Federation; 🇷🇺 Moscow, Russian Federation

Department of Internal Disease No. 5, Moscow State University of Medicine and Stomatology, Cardiology Department Moscow City Hospital No. 11; 🇷🇺 Moscow, Russian Federation

Cardiology Department Alexandrovskiy Hospital; 🇷🇺 St Petersburg, Russian Federation

Myocardial Infarction Department St Elizabeth Hospital; 🇷🇺 St Petersburg, Russian Federation

Myocardial Infarction Department St Petersburg Hodpital, No. 29; 🇷🇺 St Petersburg, Russian Federation

Klinikum Kassel Medizinische Klinik II; 🇩🇪 Kassel, Germany

Klinikum der Stadt Ludwigshafen Abteilung fur Elektrophysiologie der Kardiologie/Herzzentrum; 🇩🇪 Ludwigshafen, Germany

Universitatsklinikum Heidelberg; 🇩🇪 Heidelberg, Germany

Medizinische Klinik und Poliklnik Innere Medizin C; 🇩🇪 Mannheim, Germany

Franz-Volhard-Klinik Abteilung fur Elektrophysiologie; 🇩🇪 Berlin, Germany

Universitat Leipzig Medizinische Klinik und Poliklinik 1 Abteilung fur Kardiologie and Angiolgie; 🇩🇪 Leipzig, Germany

National Institiute of Pulmonology, Dept. of Cardiology; 🇭🇺 Budapest, Hungary

Dep. of Cardiovascular and Respiratory Diseases Policlinico Umberto I; 🇮🇹 Roma, Italy

Ospedale Umberto I di Torino; 🇮🇹 Torino, Italy

Catharina Ziekenhuis Afd. Cardilolgie; 🇳🇱 Eindhoven, Netherlands

Oddzial Kardiologii Wojewodzki Szpital Zespolony; 🇵🇱 Plock, Poland

Szpital Wolski im. Dr Anny Gostynskiej Oddzial Kardiologii; 🇵🇱 Warszawa, Poland

Moscow State University of Medicine and Stomatolog, Cardiology Department of Moscow Clinical Hospital No. 50; 🇷🇺 Moscow, Russian Federation

Hospital Universitario De Getafe Cardiology Service; 🇪🇸 Getafe, Spain

Moscow State Institute of Peace and Friendship Pharmacology Department, Moscow Clinical Hospital #64; 🇷🇺 Moscow, Russian Federation

Cardiology Department St Petersburg Hospital No. 2; 🇷🇺 St Petersburg, Russian Federation

Cardiology Department St. Petersburg State Pavlov Medical University; 🇷🇺 St Petersburg, Russian Federation

Department of Cardiology No. 3 Pokrovskiy Hospital; 🇷🇺 St Petersburg, Russian Federation

Hospital Civil De Basurto Cardiology Service; 🇪🇸 Basurto-Bilbao, Spain

Hospital Valle de Hebron Servicio de Cardiologia; 🇪🇸 Barcelona, Spain

Hospital Princeps d'Espanya (Bellvitge) Servicio de cardiologia; 🇪🇸 Barcelona, Spain

Cardiology Department, St Petersburg Hospital, No. 15; 🇷🇺 St Petersburg, Russian Federation

Hospital Nuestra Senora de Alarcos Unidad de Medicina Intensiva; 🇪🇸 Ciudad Real, Spain

Fundacion Jimenez Diaz Cardiology Service; 🇪🇸 Madrid, Spain

Hospital Clinico Universitario San Carlos Servicio de Cardiologia; 🇪🇸 Madrid, Spain

Hospital La Paz U.M.Q. de cardiologia; 🇪🇸 Madrid, Spain

Hospital de Txagorritxu; 🇪🇸 Vitoria, Spain

Oddzial Kardiologii Wojewodzkie Centrum Medyczne; 🇵🇱 Opole, Poland

Oddizial Kardiologii Szpital Wojewodzki nr 2; 🇵🇱 Rzeszow, Poland

County Hospital, Dept. of Internal Medicine I.; 🇭🇺 Kecskemet, Hungary

University of Pecs, Cardiology Clinic; 🇭🇺 Pecs, Hungary

I Klinika Chorob Serca Instytut Kardiologii AM; 🇵🇱 Gdansk, Poland

Instytut Kardiologii CMUJ Klinika Choroby Wiencowej; 🇵🇱 Krakow, Poland

Oddzial Kardilolgii Wojewodski Szpital Specjalistyczny; 🇵🇱 Olsztyn, Poland

Debrecen City Health Service; 🇭🇺 Debrecen, Hungary

County Hospital, Dept. of Internal Medicine; 🇭🇺 Szentes, Hungary

Gornoslaskie Centrum Medyczne I Klinika Kardiologii; 🇵🇱 Katowice, Poland

I Klinika Kardiologii CSK WAM; 🇵🇱 Warszawa, Poland

Gottsegen Gyorgy National Institute of Cardiology; 🇭🇺 Budapest, Hungary

State Hospital; 🇭🇺 Balatonfured, Hungary

Miskolc County Hospital; 🇭🇺 Miskolc, Hungary

Mosonmagyarovar City Karolina Hospital; 🇭🇺 Mosonmagyarovar, Hungary

Siofok City Hospital; 🇭🇺 Siofok, Hungary

Markusovszky Hospital, Dept. of Internal Medicine III.; 🇭🇺 Szombathely, Hungary

Oddizial Kardiologii Wojewodzki Szpital Zespolony; 🇵🇱 Ul Ujejskiego 75, Bydgoszcz, Poland

Szpital Wojewodzki Oddzial Kardiologii; 🇵🇱 Kielce, Poland

Oddizial Wewnetzny Szpital Miejski; 🇵🇱 Ostrowiec Swietokrzyski, Poland

Instytut Kardiologii; 🇵🇱 Warszawa, Poland

Klinika Kardiologii IV Wojskowy Szpital Kliniczny; 🇵🇱 Wroclaw, Poland

Szent Gyorgy Hospital; 🇭🇺 Szekesfehervar, Hungary

Klinika Gastroenterologii i Chorob Wewnetrznych Szpital Wojewodzki Zespolony im. Biziela; 🇵🇱 Ul Ujejskiego 75, Bydgoszcz, Poland

Samodzielny Publiczny Szpital Kliniczny Klinika Kardiologii; 🇵🇱 Bialystok, Poland

Wojewodzki Szpital Zespolony Oddzial Kardilolgii; 🇵🇱 Torun, Poland

Szent Imre Hospital, Dept. of Internal MedicineI.; 🇭🇺 Budapest, Hungary

Toldi Ferenc Hospital, Dept. of Internal Medicine II.; 🇭🇺 Cegled, Hungary

Pandy Kalman Hospital; 🇭🇺 Gyula, Hungary

Allami Szanatorium; 🇭🇺 Sopron, Hungary

Radomski Szpital Specjalistyczny Oddzial Kardiologii; 🇵🇱 Radom, Poland

Res. Inst. of Physical and Chemical Medicine Department of Cardiology Moscow Clinical Hospital No. 29; 🇷🇺 Moscow, Russian Federation