Efficacy and Safety Evaluation of Azimilide or Sotalol vs Placebo for Treatment of Patients With Atrial Fibrillation.
NCT ID: NCT00035451
Last Updated: 2011-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
658 participants
INTERVENTIONAL
2001-02-28
2003-06-30
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
placebo tablets
Placebo
tablets, twice daily for 6 months
2
Sotalol
Sotalol
160 mg sot twice daily for 6 months
3
azimilide
Azimilide Dihydrochloride
125 mg azimilide tablets, twice a day for 6 months
Interventions
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Azimilide Dihydrochloride
125 mg azimilide tablets, twice a day for 6 months
Placebo
tablets, twice daily for 6 months
Sotalol
160 mg sot twice daily for 6 months
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Forest Laboratories
INDUSTRY
Responsible Party
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Principal Investigators
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Paloma Cuenca, MD
Role: STUDY_DIRECTOR
Procter and Gamble
Locations
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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
Besançon, , 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
Cardilolgie Hopital Guillaume et Rene Laennec
Nantes, , France
Service de Cardiologie Hopital Lariboisiere
Paris, , France
Service de Cardiologie et Maladies Vascularies CHRU Pontchaillou
Rennes, , France
Cardiologie CHRU St Etienne/Hopital Nord
Saint-Etienne, , France
Centre Hospitalier General Hospital De Girac
Saint-Michel-sur-Orge, , France
Cardiologie/Pavillon Baudot Centre Hospitalier Universitaire Purpan
Toulouse, , France
Cardiologie A CHU Rangueil
Toulouse, , France
Service de cardiologie Hopitaux de Brabois/CHRU Nancy
Vandœuvre-lès-Nancy, , France
Erzgebirgskrankenhaus Klinik fur Innere Medizin
Annaberg, , Germany
Kerckhhoff-Klinik Abteilung Klinische Pharmakologie
Bad Nauheim, , Germany
Kardiologie Herzzentrum Osnabruck
Bad Rothenfelde, , Germany
Dr. Schreiber Krankenhaus Neukoelin 1 Innere Rudowerstrasse, 48
Berlin, , Germany
Franz-Volhard-Klinik Abteilung fur Elektrophysiologie
Berlin, , Germany
Stadisches Klinikum Brandenburg Med-Klinik I/Kardiologie Pulmologie und Angiologie
Brandenburg, , Germany
Klinikum Coburg II Med. Klinik
Coburg, , Germany
Klinkum Lippe-Detmold Med. Klink II-Kardiologie
Detmold, , Germany
Krankenhaus Duren Medizinische Klinik I Kardiologie/Angiologie
Düren, , Germany
Klinikum Erfurt GmbH
Erfurt, , Germany
Medizinische Universitaetsklinik Innere Medizin III Kardiologie und Angiologie
Frieburg, , Germany
Universitatsklinikum Hamburg-Eppendork Klinik und Poliklinik fur Innere Medizin Abteilung Kardiologie
Hamburg, , Germany
Medizinische Hochschule Innere Medizin/Abt. fur Kardiologie
Hanover, , Germany
Universitatsklinikum Heidelberg
Heidelberg, , Germany
Medizinische Universitats-und Ploiklinik Innere Medizin 3
Homburg, , Germany
Klinikum Kassel Medizinische Klinik II
Kassel, , Germany
Universitate zu Koeln Klinik III fur Innere Medizin
Koeln (Lindenthal), , Germany
Universitat Leipzig Medizinische Klinik und Poliklinik 1 Abteilung fur Kardiologie and Angiolgie
Leipzig, , Germany
Klinikum der Stadt Ludwigshafen Abteilung fur Elektrophysiologie der Kardiologie/Herzzentrum
Ludwigshafen, , Germany
Medizinische Klinik und Poliklnik Innere Medizin C
Mannheim, , Germany
Medizinische Klinik und Poliklinik Innere Medizin C
Münster, , Germany
Klinik am See REHA-Zentrum fur Herz und Kreislauf
Rüdersdorf, , Germany
Medizinische Universitat Tubingen Med. Klinik III, Abt. III fur Kardiologie
Tübingen, , Germany
Reinhard-Nieter-Krankenhaus Med. Klinik 1
Wilhelmshafen, , Germany
State Hospital
Balatonfüred, , Hungary
Gottsegen Gyorgy National Institute of Cardiology
Budapest, , Hungary
Szent Imre Hospital, Dept. of Internal MedicineI.
Budapest, , Hungary
Semmelweis University, Dept. of Internal Medicine III.
Budapest, , Hungary
National Institiute of Pulmonology, Dept. of Cardiology
Budapest, , Hungary
Toldi Ferenc Hospital, Dept. of Internal Medicine II.
Cegléd, , Hungary
Debrecen City Health Service
Debrecen, , Hungary
Markoth Ferenc County Hospital
Eger, , Hungary
Pandy Kalman Hospital
Gyula, , Hungary
County Hospital, Dept. of Internal Medicine I.
Kecskemét, , Hungary
Miskolc County Hospital
Miskolc, , Hungary
Mosonmagyarovar City Karolina Hospital
Mosonmagyaróvár, , Hungary
University of Pecs, Cardiology Clinic
Pécs, , Hungary
Siofok City Hospital
Siófok, , Hungary
Allami Szanatorium
Sopron, , Hungary
County Hospital, Dept. of Internal Medicine
Szentes, , Hungary
Szent Gyorgy Hospital
Székesfehérvár, , Hungary
Markusovszky Hospital, Dept. of Internal Medicine III.
Szombathely, , Hungary
Divisione di Cardiologia Ospedale Civile
Asti, , Italy
Cardiovascular Disease Unit University of Bari-Ploiclinico
Bari, , Italy
Azienda Ospedaliera "Garibaldi S, Luigi Ascoli Tomaselli" Servizio di Cardiologia
Catania, , Italy
Servizio di Cardiologia Azienda Ospedaliera S. Anna
Como, , Italy
Cardiology Division Hospital "Santa Croce e Carle"
Cuneo, , Italy
Department of Internal Medicine (DIMI) University of Genova
Genova, , Italy
Ospedale Civile Umberto I Cardiology Division
Mestre, , Italy
S. Paolo Hospital University of Milan Department of Cardiology
Milan, , Italy
Cardiology Unit University of Naples "Frederico II"
Napoli, , Italy
Cardiology Unit Policlinico S. Matteo
Pavia, , Italy
Osp. Civile di Piacenza-Div. di Cardiologia
Piacenza, , Italy
Dep. of Cardiovascular and Respiratory Diseases Policlinico Umberto I
Roma, , Italy
Ospedale Umberto I di Torino
Torino, , Italy
Catharina Ziekenhuis Afd. Cardilolgie
Eindhoven, , Netherlands
Kennemer Gasthuis
Haarlem, , Netherlands
Isala Klinieken Locatie De Weezenlanden
JW Zwolle, , Netherlands
Academisch Ziekenhuis Maastricht Afdeling Cardiologie
Maastricht, , Netherlands
Department Cardiology Canisius Wilhelmina Hospital
Nijmegen, , Netherlands
St Elisabeth Ziekenhuis Afdeling Cardiologie
Tilburg, , Netherlands
Klinika Gastroenterologii i Chorob Wewnetrznych Szpital Wojewodzki Zespolony im. Biziela
Ul Ujejskiego 75, Bydgoszcz, Poland
Oddizial Kardiologii Wojewodzki Szpital Zespolony
Ul Ujejskiego 75, Bydgoszcz, Poland
Samodzielny Publiczny Szpital Kliniczny Klinika Kardiologii
Bialystok, , Poland
I Klinika Chorob Serca Instytut Kardiologii AM
Gdansk, , Poland
Gornoslaskie Centrum Medyczne I Klinika Kardiologii
Katowice, , Poland
Szpital Wojewodzki Oddzial Kardiologii
Kielce, , Poland
Instytut Kardiologii CMUJ Klinika Choroby Wiencowej
Krakow, , Poland
Oddzial Kardilolgii Wojewodski Szpital Specjalistyczny
Olsztyn, , Poland
Oddzial Kardiologii Wojewodzkie Centrum Medyczne
Opole, , Poland
Oddizial Wewnetzny Szpital Miejski
Ostrowiec Świętokrzyski, , Poland
Oddzial Kardiologii Wojewodzki Szpital Zespolony
Płock, , Poland
Radomski Szpital Specjalistyczny Oddzial Kardiologii
Radom, , Poland
Oddizial Kardiologii Szpital Wojewodzki nr 2
Rzeszów, , Poland
Samodzielny Publiczny Szpital Zespolony Oddizial Kardiologii
Szczecin, , Poland
Wojewodzki Szpital Zespolony Oddzial Kardilolgii
Torun, , Poland
I Klinika Kardiologii CSK WAM
Warsaw, , Poland
Szpital Wolski im. Dr Anny Gostynskiej Oddzial Kardiologii
Warsaw, , Poland
Instytut Kardiologii
Warsaw, , Poland
Klinika Kardiologii IV Wojskowy Szpital Kliniczny
Wroclaw, , Poland
Oddzial Kardiologii Szpital Wojewodzki
Zamość, , Poland
Cardiology Department, Moscow Clinical Hospital No. 59
Moscow, , Russia
Res. Inst. of Physical and Chemical Medicine Department of Cardiology Moscow Clinical Hospital No. 29
Moscow, , Russia
Russian State Medical University Clinical facility: Cardiology Department of City Clinical Hospital No. 4
Moscow, , Russia
Moscow State Institute of Peace and Friendship Pharmacology Department, Moscow Clinical Hospital #64
Moscow, , Russia
Cardiology Department Moscow Sechenov Medical Academy
Moscow, , Russia
Medical Centre of General Management Department of the President of the Russian Federation, Cardiology Department Moscow Clinical Hospital No. 51
Moscow, , Russia
Medical Centre of General Management Department of the President of the Russian Federation
Moscow, , Russia
Cardiology Department of State Medical Academy of Postgraduate Education, Myasnikov Clinical Cardiology Research Institute
Moscow, , Russia
Department of Emergency Cardiology Russian Cardiology Research Centre
Moscow, , Russia
Moscow State University of Medicine and Stomatolog, Cardiology Department of Moscow Clinical Hospital No. 50
Moscow, , Russia
Department of Internal Disease No. 5, Moscow State University of Medicine and Stomatology, Cardiology Department Moscow City Hospital No. 11
Moscow, , Russia
Myocardial Infarction Department St Petersburg Hospital, No. 28
Saint Petersburg, , Russia
Cardiology Department, State Research Institute
Saint Petersburg, , Russia
Cardiology Department Alexandrovskiy Hospital
Saint Petersburg, , Russia
Cardiology Department St Petersburg Hospital No. 2
Saint Petersburg, , Russia
Myocardial Infarction Department St Elizabeth Hospital
Saint Petersburg, , Russia
Cardiology Department St. Petersburg State Pavlov Medical University
Saint Petersburg, , Russia
Myocardial Infarction Department St Petersburg Hodpital, No. 29
Saint Petersburg, , Russia
Cardiology Department, St Petersburg Hospital, No. 15
Saint Petersburg, , Russia
Department of Cardiology No. 3 Pokrovskiy Hospital
Saint Petersburg, , Russia
Hospital Universitari San Juan Servicio di Cardiologia
Alicante, , Spain
Hospital Valle de Hebron Servicio de Cardiologia
Barcelona, , Spain
Hospital Princeps d'Espanya (Bellvitge) Servicio de cardiologia
Barcelona, , Spain
Hospital Civil De Basurto Cardiology Service
Basurto-Bilbao, , Spain
Hospital Nuestra Senora de Alarcos Unidad de Medicina Intensiva
Ciudad Real, , Spain
Hospital Universitario De Getafe Cardiology Service
Getafe, , 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-Gasteiz, , Spain
Countries
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Other Identifiers
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1999105
Identifier Type: -
Identifier Source: org_study_id