Clinical trial NCT00035451: Efficacy and Safety Evaluation of Azimilide or Sotalol vs Placebo for Treatment of Patients With Atrial Fibrillation.
Official title: Efficacy and Safety Evaluation of Azimilide or Sotalol vs Placebo for Treatment of Patients With Atrial Fibrillation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atrial Fibrillation
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2002-05-06
Enrollment: 658
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: To prolong the time to first symptomatic or asymptomatic AFIB, etc event
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Clinique Generale Saint Jean Service de cardiologie
city: Brussels
country: Belgium
facility: Hospital Universitarie Erasme
city: Yvoir
country: Belgium
facility: Cliniques Univeristaires UCL Mont-Godinne Avenue Theresse 1
city: Aix-En-Provence
country: France
facility: Service de Cardilolgie CH du Pays d'Aix
city: Besancon
country: France
facility: CHR Besancon Service de cardiologie
city: Clermont-Ferrand
country: France
facility: Hopital Gavriel Montpied Cardiologie-Maladie cardiovascularies
city: Grenoble
country: France
facility: Service de Cardiologie CHRU
city: Ivry-Sur-Seine
country: France
facility: Cardiologie Hopital Jean Rostand
city: Lille
country: France
facility: Service de Cardiologie A Hopital Cardiologique
city: Lomme
country: France
facility: Service de Cardiologie Hopital Saint Philibert
city: Nantes
country: France
facility: Cardilolgie Hopital Guillaume et Rene Laennec
city: Paris
country: France
facility: Service de Cardiologie Hopital Lariboisiere
city: Rennes
country: France
facility: Service de Cardiologie et Maladies Vascularies CHRU Pontchaillou
city: Saint-Etienne
country: France
facility: Cardiologie CHRU St Etienne/Hopital Nord
city: St Michel
country: France
facility: Centre Hospitalier General Hospital De Girac
city: Toulouse
country: France
facility: Cardiologie/Pavillon Baudot Centre Hospitalier Universitaire Purpan
city: Toulouse
country: France
facility: Cardiologie A CHU Rangueil
city: Vandoeuvre les Nancy
country: France
facility: Service de cardiologie Hopitaux de Brabois/CHRU Nancy
city: Annaberg
country: Germany
facility: Erzgebirgskrankenhaus Klinik fur Innere Medizin
city: Bad Nauheim
country: Germany
facility: Kerckhhoff-Klinik Abteilung Klinische Pharmakologie
city: Bad Rothenfelde
country: Germany
facility: Kardiologie Herzzentrum Osnabruck
city: Berlin
country: Germany
facility: Dr. Schreiber Krankenhaus Neukoelin 1 Innere Rudowerstrasse, 48
city: Berlin
country: Germany
facility: Franz-Volhard-Klinik Abteilung fur Elektrophysiologie
city: Brandenburg
country: Germany
facility: Stadisches Klinikum Brandenburg Med-Klinik I/Kardiologie Pulmologie und Angiologie
city: Coburg
country: Germany
facility: Klinikum Coburg II Med. Klinik
city: Detmold
country: Germany
facility: Klinkum Lippe-Detmold Med. Klink II-Kardiologie
city: Dueren
country: Germany
facility: Krankenhaus Duren Medizinische Klinik I Kardiologie/Angiologie
city: Erfurt
country: Germany
facility: Klinikum Erfurt GmbH
city: Frieburg
country: Germany
facility: Medizinische Universitaetsklinik Innere Medizin III Kardiologie und Angiologie
city: Hamburg
country: Germany
facility: Universitatsklinikum Hamburg-Eppendork Klinik und Poliklinik fur Innere Medizin Abteilung Kardiologie
city: Hannover
country: Germany
facility: Medizinische Hochschule Innere Medizin/Abt. fur Kardiologie
city: Heidelberg
country: Germany
facility: Universitatsklinikum Heidelberg
city: Homburg
country: Germany
facility: Medizinische Universitats-und Ploiklinik Innere Medizin 3
city: Kassel
country: Germany
facility: Klinikum Kassel Medizinische Klinik II
city: Koeln (Lindenthal)
country: Germany
facility: Universitate zu Koeln Klinik III fur Innere Medizin
city: Leipzig
country: Germany
facility: Universitat Leipzig Medizinische Klinik und Poliklinik 1 Abteilung fur Kardiologie and Angiolgie
city: Ludwigshafen
country: Germany
facility: Klinikum der Stadt Ludwigshafen Abteilung fur Elektrophysiologie der Kardiologie/Herzzentrum
city: Mannheim
country: Germany
facility: Medizinische Klinik und Poliklnik Innere Medizin C
city: Munster
country: Germany
facility: Medizinische Klinik und Poliklinik Innere Medizin C
city: Ruedersdorf
country: Germany
facility: Klinik am See REHA-Zentrum fur Herz und Kreislauf
city: Tuebingen
country: Germany
facility: Medizinische Universitat Tubingen Med. Klinik III, Abt. III fur Kardiologie
city: Wilhelmshafen
country: Germany
facility: Reinhard-Nieter-Krankenhaus Med. Klinik 1
city: Balatonfured
country: Hungary
facility: State Hospital
city: Budapest
country: Hungary
facility: Gottsegen Gyorgy National Institute of Cardiology
city: Budapest
country: Hungary
facility: Szent Imre Hospital, Dept. of Internal MedicineI.
city: Budapest
country: Hungary
facility: Semmelweis University, Dept. of Internal Medicine III.
city: Budapest
country: Hungary
facility: National Institiute of Pulmonology, Dept. of Cardiology
city: Cegled
country: Hungary
facility: Toldi Ferenc Hospital, Dept. of Internal Medicine II.
city: Debrecen
country: Hungary
facility: Debrecen City Health Service
city: Eger
country: Hungary
facility: Markoth Ferenc County Hospital
city: Gyula
country: Hungary
facility: Pandy Kalman Hospital
city: Kecskemet
country: Hungary
facility: County Hospital, Dept. of Internal Medicine I.
city: Miskolc
country: Hungary
facility: Miskolc County Hospital
city: Mosonmagyarovar
country: Hungary
facility: Mosonmagyarovar City Karolina Hospital
city: Pecs
country: Hungary
facility: University of Pecs, Cardiology Clinic
city: Siofok
country: Hungary
facility: Siofok City Hospital
city: Sopron
country: Hungary
facility: Allami Szanatorium
city: Szekesfehervar
country: Hungary
facility: Szent Gyorgy Hospital
city: Szentes
country: Hungary
facility: County Hospital, Dept. of Internal Medicine
city: Szombathely
country: Hungary
facility: Markusovszky Hospital, Dept. of Internal Medicine III.
city: Asti
country: Italy
facility: Divisione di Cardiologia Ospedale Civile
city: Bari
country: Italy
facility: Cardiovascular Disease Unit University of Bari-Ploiclinico
city: Catania
country: Italy
facility: Azienda Ospedaliera "Garibaldi S, Luigi Ascoli Tomaselli" Servizio di Cardiologia
city: Como
country: Italy
facility: Servizio di Cardiologia Azienda Ospedaliera S. Anna
city: Cuneo
country: Italy
facility: Cardiology Division Hospital "Santa Croce e Carle"
city: Genova
country: Italy
facility: Department of Internal Medicine (DIMI) University of Genova
city: Mestre
country: Italy
facility: Ospedale Civile Umberto I Cardiology Division
city: Milano
country: Italy
facility: S. Paolo Hospital University of Milan Department of Cardiology
city: Napoli
country: Italy
facility: Cardiology Unit University of Naples "Frederico II"
city: Pavia
country: Italy
facility: Cardiology Unit Policlinico S. Matteo
city: Piacenza
country: Italy
facility: Osp. Civile di Piacenza-Div. di Cardiologia
city: Roma
country: Italy
facility: Dep. of Cardiovascular and Respiratory Diseases Policlinico Umberto I
city: Torino
country: Italy
facility: Ospedale Umberto I di Torino
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis Afd. Cardilolgie
city: Haarlem
country: Netherlands
facility: Kennemer Gasthuis
city: JW Zwolle
country: Netherlands
facility: Isala Klinieken Locatie De Weezenlanden
city: Maastricht
country: Netherlands
facility: Academisch Ziekenhuis Maastricht Afdeling Cardiologie
city: Nijmegen
country: Netherlands
facility: Department Cardiology Canisius Wilhelmina Hospital
city: Tilburg
country: Netherlands
facility: St Elisabeth Ziekenhuis Afdeling Cardiologie
city: Ul Ujejskiego 75
country: Poland
facility: Klinika Gastroenterologii i Chorob Wewnetrznych Szpital Wojewodzki Zespolony im. Biziela
state: Bydgoszcz
city: Ul Ujejskiego 75
country: Poland
facility: Oddizial Kardiologii Wojewodzki Szpital Zespolony
state: Bydgoszcz
city: Bialystok
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Klinika Kardiologii
city: Gdansk
country: Poland
facility: I Klinika Chorob Serca Instytut Kardiologii AM
city: Katowice
country: Poland
facility: Gornoslaskie Centrum Medyczne I Klinika Kardiologii
city: Kielce
country: Poland
facility: Szpital Wojewodzki Oddzial Kardiologii
city: Krakow
country: Poland
facility: Instytut Kardiologii CMUJ Klinika Choroby Wiencowej
city: Olsztyn
country: Poland
facility: Oddzial Kardilolgii Wojewodski Szpital Specjalistyczny
city: Opole
country: Poland
facility: Oddzial Kardiologii Wojewodzkie Centrum Medyczne
city: Ostrowiec Swietokrzyski
country: Poland
facility: Oddizial Wewnetzny Szpital Miejski
city: Plock
country: Poland
facility: Oddzial Kardiologii Wojewodzki Szpital Zespolony
city: Radom
country: Poland
facility: Radomski Szpital Specjalistyczny Oddzial Kardiologii
city: Rzeszow
country: Poland
facility: Oddizial Kardiologii Szpital Wojewodzki nr 2
city: Szczecin
country: Poland
facility: Samodzielny Publiczny Szpital Zespolony Oddizial Kardiologii
city: Torun
country: Poland
facility: Wojewodzki Szpital Zespolony Oddzial Kardilolgii
city: Warszawa
country: Poland
facility: I Klinika Kardiologii CSK WAM
city: Warszawa
country: Poland
facility: Szpital Wolski im. Dr Anny Gostynskiej Oddzial Kardiologii
city: Warszawa
country: Poland
facility: Instytut Kardiologii
city: Wroclaw
country: Poland
facility: Klinika Kardiologii IV Wojskowy Szpital Kliniczny
city: Zamosc
country: Poland
facility: Oddzial Kardiologii Szpital Wojewodzki
city: Moscow
country: Russian Federation
facility: Cardiology Department, Moscow Clinical Hospital No. 59
city: Moscow
country: Russian Federation
facility: Res. Inst. of Physical and Chemical Medicine Department of Cardiology Moscow Clinical Hospital No. 29
city: Moscow
country: Russian Federation
facility: Russian State Medical University Clinical facility: Cardiology Department of City Clinical Hospital No. 4
city: Moscow
country: Russian Federation
facility: Moscow State Institute of Peace and Friendship Pharmacology Department, Moscow Clinical Hospital #64
city: Moscow
country: Russian Federation
facility: Cardiology Department Moscow Sechenov Medical Academy
city: Moscow
country: Russian Federation
facility: Medical Centre of General Management Department of the President of the Russian Federation, Cardiology Department Moscow Clinical Hospital No. 51
city: Moscow
country: Russian Federation
facility: Medical Centre of General Management Department of the President of the Russian Federation
city: Moscow
country: Russian Federation
facility: Cardiology Department of State Medical Academy of Postgraduate Education, Myasnikov Clinical Cardiology Research Institute
city: Moscow
country: Russian Federation
facility: Department of Emergency Cardiology Russian Cardiology Research Centre
city: Moscow
country: Russian Federation
facility: Moscow State University of Medicine and Stomatolog, Cardiology Department of Moscow Clinical Hospital No. 50
city: Moscow
country: Russian Federation
facility: Department of Internal Disease No. 5, Moscow State University of Medicine and Stomatology, Cardiology Department Moscow City Hospital No. 11
city: St Petersburg
country: Russian Federation
facility: Myocardial Infarction Department St Petersburg Hospital, No. 28
city: St Petersburg
country: Russian Federation
facility: Cardiology Department, State Research Institute
city: St Petersburg
country: Russian Federation
facility: Cardiology Department Alexandrovskiy Hospital
city: St Petersburg
country: Russian Federation
facility: Cardiology Department St Petersburg Hospital No. 2
city: St Petersburg
country: Russian Federation
facility: Myocardial Infarction Department St Elizabeth Hospital
city: St Petersburg
country: Russian Federation
facility: Cardiology Department St. Petersburg State Pavlov Medical University
city: St Petersburg
country: Russian Federation
facility: Myocardial Infarction Department St Petersburg Hodpital, No. 29
city: St Petersburg
country: Russian Federation
facility: Cardiology Department, St Petersburg Hospital, No. 15
city: St Petersburg
country: Russian Federation
facility: Department of Cardiology No. 3 Pokrovskiy Hospital
city: Alicante
country: Spain
facility: Hospital Universitari San Juan Servicio di Cardiologia
city: Barcelona
country: Spain
facility: Hospital Valle de Hebron Servicio de Cardiologia
city: Barcelona
country: Spain
facility: Hospital Princeps d'Espanya (Bellvitge) Servicio de cardiologia
city: Basurto-Bilbao
country: Spain
facility: Hospital Civil De Basurto Cardiology Service
city: Ciudad Real
country: Spain
facility: Hospital Nuestra Senora de Alarcos Unidad de Medicina Intensiva
city: Getafe
country: Spain
facility: Hospital Universitario De Getafe Cardiology Service
city: Madrid
country: Spain
facility: Fundacion Jimenez Diaz Cardiology Service
city: Madrid
country: Spain
facility: Hospital Clinico Universitario San Carlos Servicio de Cardiologia
city: Madrid
country: Spain
facility: Hospital La Paz U.M.Q. de cardiologia
city: Vitoria
country: Spain
facility: Hospital de Txagorritxu
Study officials:
affiliation: Procter and Gamble
name: Paloma Cuenca, MD
role: STUDY_DIRECTOR
References: