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

September 30, 2011 updated by: Forest Laboratories

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

658

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1000
        • Clinique Generale Saint Jean Service de cardiologie
      • Brussels, Belgium, 1000
        • Hospital Universitarie Erasme
      • Yvoir, Belgium, 5530
        • Cliniques Univeristaires UCL Mont-Godinne Avenue Theresse 1
  • France
      • Aix-En-Provence, France, 13616
        • Service de Cardilolgie CH du Pays d'Aix
      • Besancon, France, 25030
        • CHR Besancon Service de cardiologie
      • Clermont-Ferrand, France, 63000
        • Hopital Gavriel Montpied Cardiologie-Maladie cardiovascularies
      • Grenoble, France, 38046
        • Service de Cardiologie CHRU
      • Ivry-Sur-Seine, France, 94205
        • Cardiologie Hopital Jean Rostand
      • Lille, France, 59037
        • Service de Cardiologie A Hopital Cardiologique
      • Lomme, France, 59160
        • Service de Cardiologie Hopital Saint Philibert
      • Nantes, France, 44093
        • Cardilolgie Hopital Guillaume et Rene Laennec
      • Paris, France, 75010
        • Service de Cardiologie Hopital Lariboisiere
      • Rennes, France, 35000
        • Service de Cardiologie et Maladies Vascularies CHRU Pontchaillou
      • Saint-Etienne, France, 42055
        • Cardiologie CHRU St Etienne/Hopital Nord
      • St Michel, France, 16470
        • Centre Hospitalier General Hospital De Girac
      • Toulouse, France, 31059
        • Cardiologie/Pavillon Baudot Centre Hospitalier Universitaire Purpan
      • Toulouse, France, 31403
        • Cardiologie A CHU Rangueil
      • Vandoeuvre les Nancy, France, 54511
        • Service de cardiologie Hopitaux de Brabois/CHRU Nancy
  • Germany
      • Annaberg, Germany, 09456
        • Erzgebirgskrankenhaus Klinik fur Innere Medizin
      • Bad Nauheim, Germany, 61231
        • Kerckhhoff-Klinik Abteilung Klinische Pharmakologie
      • Bad Rothenfelde, Germany, 49214
        • Kardiologie Herzzentrum Osnabruck
      • Berlin, Germany, 12351
        • Dr. Schreiber Krankenhaus Neukoelin 1 Innere Rudowerstrasse, 48
      • Berlin, Germany, 13125
        • Franz-Volhard-Klinik Abteilung fur Elektrophysiologie
      • Brandenburg, Germany, 14770
        • Stadisches Klinikum Brandenburg Med-Klinik I/Kardiologie Pulmologie und Angiologie
      • Coburg, Germany, 96450
        • Klinikum Coburg II Med. Klinik
      • Detmold, Germany, 32756
        • Klinkum Lippe-Detmold Med. Klink II-Kardiologie
      • Dueren, Germany, 52351
        • Krankenhaus Duren Medizinische Klinik I Kardiologie/Angiologie
      • Erfurt, Germany, 99012
        • Klinikum Erfurt GmbH
      • Frieburg, Germany, 79016
        • Medizinische Universitaetsklinik Innere Medizin III Kardiologie und Angiologie
      • Hamburg, Germany, 20246
        • Universitatsklinikum Hamburg-Eppendork Klinik und Poliklinik fur Innere Medizin Abteilung Kardiologie
      • Hannover, Germany, 30625
        • Medizinische Hochschule Innere Medizin/Abt. fur Kardiologie
      • Heidelberg, Germany, 69115
        • UniversitatsKlinikum Heidelberg
      • Homburg, Germany, 66421
        • Medizinische Universitats-und Ploiklinik Innere Medizin 3
      • Kassel, Germany, 34125
        • Klinikum Kassel Medizinische Klinik II
      • Koeln (Lindenthal), Germany, 50924
        • Universitate zu Koeln Klinik III fur Innere Medizin
      • Leipzig, Germany, 04103
        • Universitat Leipzig Medizinische Klinik und Poliklinik 1 Abteilung fur Kardiologie and Angiolgie
      • Ludwigshafen, Germany, 67063
        • Klinikum der Stadt Ludwigshafen Abteilung fur Elektrophysiologie der Kardiologie/Herzzentrum
      • Mannheim, Germany, 68167
        • Medizinische Klinik und Poliklnik Innere Medizin C
      • Munster, Germany, D-48149
        • Medizinische Klinik und Poliklinik Innere Medizin C
      • Ruedersdorf, Germany, 15562
        • Klinik am See REHA-Zentrum fur Herz und Kreislauf
      • Tuebingen, Germany, 72076
        • Medizinische Universitat Tubingen Med. Klinik III, Abt. III fur Kardiologie
      • Wilhelmshafen, Germany, 26389
        • Reinhard-Nieter-Krankenhaus Med. Klinik 1
  • Hungary
      • Balatonfured, Hungary, 8230
        • State Hospital
      • Budapest, Hungary, 1096
        • Gottsegen Gyorgy National Institute of Cardiology
      • Budapest, Hungary, 1115
        • Szent Imre Hospital, Dept. of Internal MedicineI.
      • Budapest, Hungary, 1125
        • Semmelweis University, Dept. of Internal Medicine III.
      • Budapest, Hungary, 1529
        • National Institiute of Pulmonology, Dept. of Cardiology
      • Cegled, Hungary, 2700
        • Toldi Ferenc Hospital, Dept. of Internal Medicine II.
      • Debrecen, Hungary, 4032
        • Debrecen City Health Service
      • Eger, Hungary, 3301
        • Markoth Ferenc County Hospital
      • Gyula, Hungary, 5700
        • Pandy Kalman Hospital
      • Kecskemet, Hungary, 6000
        • County Hospital, Dept. of Internal Medicine I.
      • Miskolc, Hungary, 3562
        • Miskolc County Hospital
      • Mosonmagyarovar, Hungary, 9200
        • Mosonmagyarovar City Karolina Hospital
      • Pecs, Hungary, 7621
        • University of Pecs, Cardiology Clinic
      • Siofok, Hungary, 8601
        • Siofok City Hospital
      • Sopron, Hungary, 9400
        • Allami Szanatorium
      • Szekesfehervar, Hungary, 8000
        • Szent Gyorgy Hospital
      • Szentes, Hungary, 6601
        • County Hospital, Dept. of Internal Medicine
      • Szombathely, Hungary, 9700
        • Markusovszky Hospital, Dept. of Internal Medicine III.
  • Italy
      • Asti, Italy, 14100
        • Divisione di Cardiologia Ospedale Civile
      • Bari, Italy, 70124
        • Cardiovascular Disease Unit University of Bari-Ploiclinico
      • Catania, Italy, 95100
        • Azienda Ospedaliera "Garibaldi S, Luigi Ascoli Tomaselli" Servizio di Cardiologia
      • Como, Italy, 22100
        • Servizio di Cardiologia Azienda Ospedaliera S. Anna
      • Cuneo, Italy, 12100
        • Cardiology Division Hospital "Santa Croce e Carle"
      • Genova, Italy, 16132
        • Department of Internal Medicine (DIMI) University of Genova
      • Mestre, Italy, 30170
        • Ospedale Civile Umberto I Cardiology Division
      • Milano, Italy, 20142
        • S. Paolo Hospital University of Milan Department of Cardiology
      • Napoli, Italy, 80131
        • Cardiology Unit University of Naples "Frederico II"
      • Pavia, Italy, 27100
        • Cardiology Unit Policlinico S. Matteo
      • Piacenza, Italy, 29100
        • Osp. Civile di Piacenza-Div. di Cardiologia
      • Roma, Italy, 00161
        • Dep. of Cardiovascular and Respiratory Diseases Policlinico Umberto I
      • Torino, Italy, 10128
        • Ospedale Umberto I di Torino
  • Netherlands
      • Eindhoven, Netherlands, 5623
        • Catharina Ziekenhuis Afd. Cardilolgie
      • Haarlem, Netherlands, 2035
        • Kennemer Gasthuis
      • JW Zwolle, Netherlands, 8011
        • Isala Klinieken Locatie De Weezenlanden
      • Maastricht, Netherlands, 6229
        • Academisch Ziekenhuis Maastricht Afdeling Cardiologie
      • Nijmegen, Netherlands, 6532
        • Department Cardiology Canisius Wilhelmina Hospital
      • Tilburg, Netherlands, 5022
        • St Elisabeth Ziekenhuis Afdeling Cardiologie
  • Poland
      • Bialystok, Poland, 15-276
        • Samodzielny Publiczny Szpital Kliniczny Klinika Kardiologii
      • Gdansk, Poland, 80-211
        • I Klinika Chorob Serca Instytut Kardiologii AM
      • Katowice, Poland, 40-635
        • Gornoslaskie Centrum Medyczne I Klinika Kardiologii
      • Kielce, Poland, 25-736
        • Szpital Wojewodzki Oddzial Kardiologii
      • Krakow, Poland, 31-202
        • Instytut Kardiologii CMUJ Klinika Choroby Wiencowej
      • Olsztyn, Poland, 10-561
        • Oddzial Kardilolgii Wojewodski Szpital Specjalistyczny
      • Opole, Poland, 45-418
        • Oddzial Kardiologii Wojewodzkie Centrum Medyczne
      • Ostrowiec Swietokrzyski, Poland, 27-400
        • Oddizial Wewnetzny Szpital Miejski
      • Plock, Poland, 09-400
        • Oddzial Kardiologii Wojewodzki Szpital Zespolony
      • Radom, Poland, 26-600
        • Radomski Szpital Specjalistyczny Oddzial Kardiologii
      • Rzeszow, Poland, 35-301
        • Oddizial Kardiologii Szpital Wojewodzki nr 2
      • Szczecin, Poland, 71-455
        • Samodzielny Publiczny Szpital Zespolony Oddizial Kardiologii
      • Torun, Poland, 87-100
        • Wojewodzki Szpital Zespolony Oddzial Kardilolgii
      • Warszawa, Poland, 00-909
        • I Klinika Kardiologii CSK WAM
      • Warszawa, Poland, 02-211
        • Szpital Wolski im. Dr Anny Gostynskiej Oddzial Kardiologii
      • Warszawa, Poland, 04-268
        • Instytut Kardiologii
      • Wroclaw, Poland, 50-981
        • Klinika Kardiologii IV Wojskowy Szpital Kliniczny
      • Zamosc, Poland, 22-400
        • Oddzial Kardiologii Szpital Wojewodzki
    • Bydgoszcz
      • Ul Ujejskiego 75, Bydgoszcz, Poland, 85-168
        • Klinika Gastroenterologii i Chorob Wewnetrznych Szpital Wojewodzki Zespolony im. Biziela
      • Ul Ujejskiego 75, Bydgoszcz, Poland, 85-168
        • Oddizial Kardiologii Wojewodzki Szpital Zespolony
  • Russian Federation
      • Moscow, Russian Federation, 103030
        • Cardiology Department, Moscow Clinical Hospital No. 59
      • Moscow, Russian Federation, 111020
        • Res. Inst. of Physical and Chemical Medicine Department of Cardiology Moscow Clinical Hospital No. 29
      • Moscow, Russian Federation, 113096
        • Russian State Medical University Clinical facility: Cardiology Department of City Clinical Hospital No. 4
      • Moscow, Russian Federation, 117292
        • Moscow State Institute of Peace and Friendship Pharmacology Department, Moscow Clinical Hospital #64
      • Moscow, Russian Federation, 119881
        • Cardiology Department Moscow Sechenov Medical Academy
      • Moscow, Russian Federation, 121309
        • Medical Centre of General Management Department of the President of the Russian Federation, Cardiology Department Moscow Clinical Hospital No. 51
      • Moscow, Russian Federation, 121356
        • Medical Centre of General Management Department of the President of the Russian Federation
      • Moscow, Russian Federation, 121552
        • Cardiology Department of State Medical Academy of Postgraduate Education, Myasnikov Clinical Cardiology Research Institute
      • Moscow, Russian Federation, 121552
        • Department of Emergency Cardiology Russian Cardiology Research Centre
      • Moscow, Russian Federation, 125206
        • Moscow State University of Medicine and Stomatolog, Cardiology Department of Moscow Clinical Hospital No. 50
      • Moscow, Russian Federation, 127018
        • Department of Internal Disease No. 5, Moscow State University of Medicine and Stomatology, Cardiology Department Moscow City Hospital No. 11
      • St Petersburg, Russian Federation, 190000
        • Myocardial Infarction Department St Petersburg Hospital, No. 28
      • St Petersburg, Russian Federation, 192242
        • Cardiology Department, State Research Institute
      • St Petersburg, Russian Federation, 193318
        • Cardiology Department Alexandrovskiy Hospital
      • St Petersburg, Russian Federation, 194354
        • Cardiology Department St Petersburg Hospital No. 2
      • St Petersburg, Russian Federation, 195257
        • Myocardial Infarction Department St Elizabeth Hospital
      • St Petersburg, Russian Federation, 197022
        • Cardiology Department St. Petersburg State Pavlov Medical University
      • St Petersburg, Russian Federation, 197022
        • Myocardial Infarction Department St Petersburg Hodpital, No. 29
      • St Petersburg, Russian Federation, 198205
        • Cardiology Department, St Petersburg Hospital, No. 15
      • St Petersburg, Russian Federation, 199106
        • Department of Cardiology No. 3 Pokrovskiy Hospital
  • Spain
      • Alicante, Spain, 03550
        • Hospital Universitari San Juan Servicio di Cardiologia
      • Barcelona, Spain, 08035
        • Hospital Valle de Hebron Servicio de Cardiologia
      • Barcelona, Spain, 08907
        • Hospital Princeps d'Espanya (Bellvitge) Servicio de cardiologia
      • Basurto-Bilbao, Spain, 48013
        • Hospital Civil De Basurto Cardiology Service
      • Ciudad Real, Spain, 13002
        • Hospital Nuestra Senora de Alarcos Unidad de Medicina Intensiva
      • Getafe, Spain, 28905
        • Hospital Universitario De Getafe Cardiology Service
      • Madrid, Spain, 28040
        • Fundacion Jimenez Diaz Cardiology Service
      • Madrid, Spain, 28040
        • Hospital Clinico Universitario San Carlos Servicio de Cardiologia
      • Madrid, Spain, 28046
        • Hospital La Paz U.M.Q. de cardiologia
      • Vitoria, Spain, 01009
        • Hospital de Txagorritxu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 1
placebo tablets
Drug: Placebo
tablets, twice daily for 6 months
ACTIVE_COMPARATOR: 2
Sotalol
Drug: Sotalol
160 mg sot twice daily for 6 months
EXPERIMENTAL: 3
azimilide
Drug: Azimilide Dihydrochloride
125 mg azimilide tablets, twice a day for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To prolong the time to first symptomatic or asymptomatic AFIB, etc event
Time Frame: 6 month
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Forest Laboratories

Investigators

  • Study Director: Paloma Cuenca, MD, Procter and Gamble

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2001

Primary Completion (ACTUAL)

June 1, 2003

Study Completion (ACTUAL)

June 1, 2003

Study Registration Dates

First Submitted

May 3, 2002

First Submitted That Met QC Criteria

May 3, 2002

First Posted (ESTIMATE)

May 6, 2002

Study Record Updates

Last Update Posted (ESTIMATE)

October 3, 2011

Last Update Submitted That Met QC Criteria

September 30, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1999105

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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