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

Information source: Forest Laboratories
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Atrial Fibrillation

Intervention: Azimilide Dihydrochloride (Drug); Placebo (Drug); Sotalol (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Forest Laboratories

Official(s) and/or principal investigator(s):
Paloma Cuenca, MD, Study Director, Affiliation: Procter and Gamble


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

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


Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.


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


- 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

Locations and Contacts

Clinique Generale Saint Jean Service de cardiologie, Brussels 1000, Belgium

Hospital Universitarie Erasme, Brussels 1000, Belgium

Cliniques Univeristaires UCL Mont-Godinne Avenue Theresse 1, Yvoir 5530, Belgium

Service de Cardilolgie CH du Pays d'Aix, Aix-En-Provence 13616, France

CHR Besancon Service de cardiologie, Besancon 25030, France

Hopital Gavriel Montpied Cardiologie-Maladie cardiovascularies, Clermont-Ferrand 63000, France

Service de Cardiologie CHRU, Grenoble 38046, France

Cardiologie Hopital Jean Rostand, Ivry-Sur-Seine 94205, France

Service de Cardiologie A Hopital Cardiologique, Lille 59037, France

Service de Cardiologie Hopital Saint Philibert, Lomme 59160, France

Cardilolgie Hopital Guillaume et Rene Laennec, Nantes 44093, France

Service de Cardiologie Hopital Lariboisiere, Paris 75010, France

Service de Cardiologie et Maladies Vascularies CHRU Pontchaillou, Rennes 35000, France

Cardiologie CHRU St Etienne/Hopital Nord, Saint-Etienne 42055, France

Centre Hospitalier General Hospital De Girac, St Michel 16470, France

Cardiologie A CHU Rangueil, Toulouse 31403, France

Cardiologie/Pavillon Baudot Centre Hospitalier Universitaire Purpan, Toulouse 31059, France

Service de cardiologie Hopitaux de Brabois/CHRU Nancy, Vandoeuvre les Nancy 54511, France

Erzgebirgskrankenhaus Klinik fur Innere Medizin, Annaberg 09456, Germany

Kerckhhoff-Klinik Abteilung Klinische Pharmakologie, Bad Nauheim 61231, Germany

Kardiologie Herzzentrum Osnabruck, Bad Rothenfelde 49214, Germany

Dr. Schreiber Krankenhaus Neukoelin 1 Innere Rudowerstrasse, 48, Berlin 12351, Germany

Franz-Volhard-Klinik Abteilung fur Elektrophysiologie, Berlin 13125, Germany

Stadisches Klinikum Brandenburg Med-Klinik I/Kardiologie Pulmologie und Angiologie, Brandenburg 14770, Germany

Klinikum Coburg II Med. Klinik, Coburg 96450, Germany

Klinkum Lippe-Detmold Med. Klink II-Kardiologie, Detmold 32756, Germany

Krankenhaus Duren Medizinische Klinik I Kardiologie/Angiologie, Dueren 52351, Germany

Klinikum Erfurt GmbH, Erfurt 99012, Germany

Medizinische Universitaetsklinik Innere Medizin III Kardiologie und Angiologie, Frieburg 79016, Germany

Universitatsklinikum Hamburg-Eppendork Klinik und Poliklinik fur Innere Medizin Abteilung Kardiologie, Hamburg 20246, Germany

Medizinische Hochschule Innere Medizin/Abt. fur Kardiologie, Hannover 30625, Germany

Universitatsklinikum Heidelberg, Heidelberg 69115, Germany

Medizinische Universitats-und Ploiklinik Innere Medizin 3, Homburg 66421, Germany

Klinikum Kassel Medizinische Klinik II, Kassel 34125, Germany

Universitate zu Koeln Klinik III fur Innere Medizin, Koeln (Lindenthal) 50924, Germany

Universitat Leipzig Medizinische Klinik und Poliklinik 1 Abteilung fur Kardiologie and Angiolgie, Leipzig 04103, Germany

Klinikum der Stadt Ludwigshafen Abteilung fur Elektrophysiologie der Kardiologie/Herzzentrum, Ludwigshafen 67063, Germany

Medizinische Klinik und Poliklnik Innere Medizin C, Mannheim 68167, Germany

Medizinische Klinik und Poliklinik Innere Medizin C, Munster D-48149, Germany

Klinik am See REHA-Zentrum fur Herz und Kreislauf, Ruedersdorf 15562, Germany

Medizinische Universitat Tubingen Med. Klinik III, Abt. III fur Kardiologie, Tuebingen 72076, Germany

Reinhard-Nieter-Krankenhaus Med. Klinik 1, Wilhelmshafen 26389, Germany

State Hospital, Balatonfured 8230, Hungary

Gottsegen Gyorgy National Institute of Cardiology, Budapest 1096, Hungary

National Institiute of Pulmonology, Dept. of Cardiology, Budapest 1529, Hungary

Semmelweis University, Dept. of Internal Medicine III., Budapest 1125, Hungary

Szent Imre Hospital, Dept. of Internal MedicineI., Budapest 1115, Hungary

Toldi Ferenc Hospital, Dept. of Internal Medicine II., Cegled 2700, Hungary

Debrecen City Health Service, Debrecen 4032, Hungary

Markoth Ferenc County Hospital, Eger 3301, Hungary

Pandy Kalman Hospital, Gyula 5700, Hungary

County Hospital, Dept. of Internal Medicine I., Kecskemet 6000, Hungary

Miskolc County Hospital, Miskolc 3562, Hungary

Mosonmagyarovar City Karolina Hospital, Mosonmagyarovar 9200, Hungary

University of Pecs, Cardiology Clinic, Pecs 7621, Hungary

Siofok City Hospital, Siofok 8601, Hungary

Allami Szanatorium, Sopron 9400, Hungary

Szent Gyorgy Hospital, Szekesfehervar 8000, Hungary

County Hospital, Dept. of Internal Medicine, Szentes 6601, Hungary

Markusovszky Hospital, Dept. of Internal Medicine III., Szombathely 9700, Hungary

Divisione di Cardiologia Ospedale Civile, Asti 14100, Italy

Cardiovascular Disease Unit University of Bari-Ploiclinico, Bari 70124, Italy

Azienda Ospedaliera "Garibaldi S, Luigi Ascoli Tomaselli" Servizio di Cardiologia, Catania 95100, Italy

Servizio di Cardiologia Azienda Ospedaliera S. Anna, Como 22100, Italy

Cardiology Division Hospital "Santa Croce e Carle", Cuneo 12100, Italy

Department of Internal Medicine (DIMI) University of Genova, Genova 16132, Italy

Ospedale Civile Umberto I Cardiology Division, Mestre 30170, Italy

S. Paolo Hospital University of Milan Department of Cardiology, Milano 20142, Italy

Cardiology Unit University of Naples "Frederico II", Napoli 80131, Italy

Cardiology Unit Policlinico S. Matteo, Pavia 27100, Italy

Osp. Civile di Piacenza-Div. di Cardiologia, Piacenza 29100, Italy

Dep. of Cardiovascular and Respiratory Diseases Policlinico Umberto I, Roma 00161, Italy

Ospedale Umberto I di Torino, Torino 10128, Italy

Catharina Ziekenhuis Afd. Cardilolgie, Eindhoven 5623, Netherlands

Kennemer Gasthuis, Haarlem 2035, Netherlands

Isala Klinieken Locatie De Weezenlanden, JW Zwolle 8011, Netherlands

Academisch Ziekenhuis Maastricht Afdeling Cardiologie, Maastricht 6229, Netherlands

Department Cardiology Canisius Wilhelmina Hospital, Nijmegen 6532, Netherlands

St Elisabeth Ziekenhuis Afdeling Cardiologie, Tilburg 5022, Netherlands

Samodzielny Publiczny Szpital Kliniczny Klinika Kardiologii, Bialystok 15-276, Poland

I Klinika Chorob Serca Instytut Kardiologii AM, Gdansk 80-211, Poland

Gornoslaskie Centrum Medyczne I Klinika Kardiologii, Katowice 40-635, Poland

Szpital Wojewodzki Oddzial Kardiologii, Kielce 25-736, Poland

Instytut Kardiologii CMUJ Klinika Choroby Wiencowej, Krakow 31-202, Poland

Oddzial Kardilolgii Wojewodski Szpital Specjalistyczny, Olsztyn 10-561, Poland

Oddzial Kardiologii Wojewodzkie Centrum Medyczne, Opole 45-418, Poland

Oddizial Wewnetzny Szpital Miejski, Ostrowiec Swietokrzyski 27-400, Poland

Oddzial Kardiologii Wojewodzki Szpital Zespolony, Plock 09-400, Poland

Radomski Szpital Specjalistyczny Oddzial Kardiologii, Radom 26-600, Poland

Oddizial Kardiologii Szpital Wojewodzki nr 2, Rzeszow 35-301, Poland

Samodzielny Publiczny Szpital Zespolony Oddizial Kardiologii, Szczecin 71-455, Poland

Wojewodzki Szpital Zespolony Oddzial Kardilolgii, Torun 87-100, Poland

I Klinika Kardiologii CSK WAM, Warszawa 00-909, Poland

Instytut Kardiologii, Warszawa 04-268, Poland

Szpital Wolski im. Dr Anny Gostynskiej Oddzial Kardiologii, Warszawa 02-211, Poland

Klinika Kardiologii IV Wojskowy Szpital Kliniczny, Wroclaw 50-981, Poland

Oddzial Kardiologii Szpital Wojewodzki, Zamosc 22-400, Poland

Cardiology Department Moscow Sechenov Medical Academy, Moscow 119881, Russian Federation

Cardiology Department of State Medical Academy of Postgraduate Education, Myasnikov Clinical Cardiology Research Institute, Moscow 121552, Russian Federation

Cardiology Department, Moscow Clinical Hospital No. 59, Moscow 103030, Russian Federation

Department of Emergency Cardiology Russian Cardiology Research Centre, Moscow 121552, Russian Federation

Department of Internal Disease No. 5, Moscow State University of Medicine and Stomatology, Cardiology Department Moscow City Hospital No. 11, Moscow 127018, Russian Federation

Medical Centre of General Management Department of the President of the Russian Federation, Moscow 121356, Russian Federation

Medical Centre of General Management Department of the President of the Russian Federation, Cardiology Department Moscow Clinical Hospital No. 51, Moscow 121309, Russian Federation

Moscow State Institute of Peace and Friendship Pharmacology Department, Moscow Clinical Hospital #64, Moscow 117292, Russian Federation

Moscow State University of Medicine and Stomatolog, Cardiology Department of Moscow Clinical Hospital No. 50, Moscow 125206, Russian Federation

Res. Inst. of Physical and Chemical Medicine Department of Cardiology Moscow Clinical Hospital No. 29, Moscow 111020, Russian Federation

Russian State Medical University Clinical facility: Cardiology Department of City Clinical Hospital No. 4, Moscow 113096, Russian Federation

Cardiology Department Alexandrovskiy Hospital, St Petersburg 193318, Russian Federation

Cardiology Department St Petersburg Hospital No. 2, St Petersburg 194354, Russian Federation

Cardiology Department St. Petersburg State Pavlov Medical University, St Petersburg 197022, Russian Federation

Cardiology Department, St Petersburg Hospital, No. 15, St Petersburg 198205, Russian Federation

Cardiology Department, State Research Institute, St Petersburg 192242, Russian Federation

Department of Cardiology No. 3 Pokrovskiy Hospital, St Petersburg 199106, Russian Federation

Myocardial Infarction Department St Elizabeth Hospital, St Petersburg 195257, Russian Federation

Myocardial Infarction Department St Petersburg Hodpital, No. 29, St Petersburg 197022, Russian Federation

Myocardial Infarction Department St Petersburg Hospital, No. 28, St Petersburg 190000, Russian Federation

Hospital Universitari San Juan Servicio di Cardiologia, Alicante 03550, Spain

Hospital Princeps d'Espanya (Bellvitge) Servicio de cardiologia, Barcelona 08907, Spain

Hospital Valle de Hebron Servicio de Cardiologia, Barcelona 08035, Spain

Hospital Civil De Basurto Cardiology Service, Basurto-Bilbao 48013, Spain

Hospital Nuestra Senora de Alarcos Unidad de Medicina Intensiva, Ciudad Real 13002, Spain

Hospital Universitario De Getafe Cardiology Service, Getafe 28905, Spain

Fundacion Jimenez Diaz Cardiology Service, Madrid 28040, Spain

Hospital Clinico Universitario San Carlos Servicio de Cardiologia, Madrid 28040, Spain

Hospital La Paz U.M.Q. de cardiologia, Madrid 28046, Spain

Hospital de Txagorritxu, Vitoria 01009, Spain

Klinika Gastroenterologii i Chorob Wewnetrznych Szpital Wojewodzki Zespolony im. Biziela, Ul Ujejskiego 75, Bydgoszcz 85-168, Poland

Oddizial Kardiologii Wojewodzki Szpital Zespolony, Ul Ujejskiego 75, Bydgoszcz 85-168, Poland

Additional Information

Starting date: February 2001
Last updated: September 30, 2011

Page last updated: August 23, 2015

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