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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00035451
• Other study ID #: 1999105
• Status: Completed
• Phase: Phase 3
• First received: May 3, 2002
• Last updated: September 30, 2011
• Start date: February 2001
• Est. completion date: June 2003

Study information

• Verified date: September 2011
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 658
• Est. completion date: June 2003
• Est. primary completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Belgium	Clinique Generale Saint Jean Service de cardiologie	Brussels
Belgium	Hospital Universitarie Erasme	Brussels
Belgium	Cliniques Univeristaires UCL Mont-Godinne Avenue Theresse 1	Yvoir
France	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	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	St Michel
France	Cardiologie A CHU Rangueil	Toulouse
France	Cardiologie/Pavillon Baudot Centre Hospitalier Universitaire Purpan	Toulouse
France	Service de cardiologie Hopitaux de Brabois/CHRU Nancy	Vandoeuvre les Nancy
Germany	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	Dueren
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	Hannover
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	Munster
Germany	Klinik am See REHA-Zentrum fur Herz und Kreislauf	Ruedersdorf
Germany	Medizinische Universitat Tubingen Med. Klinik III, Abt. III fur Kardiologie	Tuebingen
Germany	Reinhard-Nieter-Krankenhaus Med. Klinik 1	Wilhelmshafen
Hungary	State Hospital	Balatonfured
Hungary	Gottsegen Gyorgy National Institute of Cardiology	Budapest
Hungary	National Institiute of Pulmonology, Dept. of Cardiology	Budapest
Hungary	Semmelweis University, Dept. of Internal Medicine III.	Budapest
Hungary	Szent Imre Hospital, Dept. of Internal MedicineI.	Budapest
Hungary	Toldi Ferenc Hospital, Dept. of Internal Medicine II.	Cegled
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.	Kecskemet
Hungary	Miskolc County Hospital	Miskolc
Hungary	Mosonmagyarovar City Karolina Hospital	Mosonmagyarovar
Hungary	University of Pecs, Cardiology Clinic	Pecs
Hungary	Siofok City Hospital	Siofok
Hungary	Allami Szanatorium	Sopron
Hungary	Szent Gyorgy Hospital	Szekesfehervar
Hungary	County Hospital, Dept. of Internal Medicine	Szentes
Hungary	Markusovszky Hospital, Dept. of Internal Medicine III.	Szombathely
Italy	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	Milano
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
Netherlands	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
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 Swietokrzyski
Poland	Oddzial Kardiologii Wojewodzki Szpital Zespolony	Plock
Poland	Radomski Szpital Specjalistyczny Oddzial Kardiologii	Radom
Poland	Oddizial Kardiologii Szpital Wojewodzki nr 2	Rzeszow
Poland	Samodzielny Publiczny Szpital Zespolony Oddizial Kardiologii	Szczecin
Poland	Wojewodzki Szpital Zespolony Oddzial Kardilolgii	Torun
Poland	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	I Klinika Kardiologii CSK WAM	Warszawa
Poland	Instytut Kardiologii	Warszawa
Poland	Szpital Wolski im. Dr Anny Gostynskiej Oddzial Kardiologii	Warszawa
Poland	Klinika Kardiologii IV Wojskowy Szpital Kliniczny	Wroclaw
Poland	Oddzial Kardiologii Szpital Wojewodzki	Zamosc
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	Cardiology Department, Moscow Clinical Hospital No. 59	Moscow
Russian Federation	Department of Emergency Cardiology Russian Cardiology Research Centre	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	Medical Centre of General Management Department of the President of the Russian Federation	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	Moscow State Institute of Peace and Friendship Pharmacology Department, Moscow Clinical Hospital #64	Moscow
Russian Federation	Moscow State University of Medicine and Stomatolog, Cardiology Department of Moscow Clinical Hospital No. 50	Moscow
Russian Federation	Res. Inst. of Physical and Chemical Medicine Department of Cardiology Moscow Clinical Hospital No. 29	Moscow
Russian Federation	Russian State Medical University Clinical facility: Cardiology Department of City Clinical Hospital No. 4	Moscow
Russian Federation	Cardiology Department Alexandrovskiy Hospital	St Petersburg
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	Cardiology Department, St Petersburg Hospital, No. 15	St Petersburg
Russian Federation	Cardiology Department, State Research Institute	St Petersburg
Russian Federation	Department of Cardiology No. 3 Pokrovskiy 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	Myocardial Infarction Department St Petersburg Hospital, No. 28	St Petersburg
Spain	Hospital Universitari San Juan Servicio di Cardiologia	Alicante
Spain	Hospital Princeps d'Espanya (Bellvitge) Servicio de cardiologia	Barcelona
Spain	Hospital Valle de Hebron 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

Sponsors (1)

Lead Sponsor	Collaborator
Forest Laboratories

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Hungary,  Italy,  Netherlands,  Poland,  Russian Federation,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To prolong the time to first symptomatic or asymptomatic AFIB, etc event		6 month	No