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

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Azimilide Dihydrochloride
Placebo
Sotalol
Sponsored by
Forest Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinique Generale Saint Jean Service de cardiologie
  • Hospital Universitarie Erasme
  • Cliniques Univeristaires UCL Mont-Godinne Avenue Theresse 1
  • Service de Cardilolgie CH du Pays d'Aix
  • CHR Besancon Service de cardiologie
  • Hopital Gavriel Montpied Cardiologie-Maladie cardiovascularies
  • Service de Cardiologie CHRU
  • Cardiologie Hopital Jean Rostand
  • Service de Cardiologie A Hopital Cardiologique
  • Service de Cardiologie Hopital Saint Philibert
  • Cardilolgie Hopital Guillaume et Rene Laennec
  • Service de Cardiologie Hopital Lariboisiere
  • Service de Cardiologie et Maladies Vascularies CHRU Pontchaillou
  • Cardiologie CHRU St Etienne/Hopital Nord
  • Centre Hospitalier General Hospital De Girac
  • Cardiologie/Pavillon Baudot Centre Hospitalier Universitaire Purpan
  • Cardiologie A CHU Rangueil
  • Service de cardiologie Hopitaux de Brabois/CHRU Nancy
  • Erzgebirgskrankenhaus Klinik fur Innere Medizin
  • Kerckhhoff-Klinik Abteilung Klinische Pharmakologie
  • Kardiologie Herzzentrum Osnabruck
  • Dr. Schreiber Krankenhaus Neukoelin 1 Innere Rudowerstrasse, 48
  • Franz-Volhard-Klinik Abteilung fur Elektrophysiologie
  • Stadisches Klinikum Brandenburg Med-Klinik I/Kardiologie Pulmologie und Angiologie
  • Klinikum Coburg II Med. Klinik
  • Klinkum Lippe-Detmold Med. Klink II-Kardiologie
  • Krankenhaus Duren Medizinische Klinik I Kardiologie/Angiologie
  • Klinikum Erfurt GmbH
  • Medizinische Universitaetsklinik Innere Medizin III Kardiologie und Angiologie
  • Universitatsklinikum Hamburg-Eppendork Klinik und Poliklinik fur Innere Medizin Abteilung Kardiologie
  • Medizinische Hochschule Innere Medizin/Abt. fur Kardiologie
  • Universitatsklinikum Heidelberg
  • Medizinische Universitats-und Ploiklinik Innere Medizin 3
  • Klinikum Kassel Medizinische Klinik II
  • Universitate zu Koeln Klinik III fur Innere Medizin
  • Universitat Leipzig Medizinische Klinik und Poliklinik 1 Abteilung fur Kardiologie and Angiolgie
  • Klinikum der Stadt Ludwigshafen Abteilung fur Elektrophysiologie der Kardiologie/Herzzentrum
  • Medizinische Klinik und Poliklnik Innere Medizin C
  • Medizinische Klinik und Poliklinik Innere Medizin C
  • Klinik am See REHA-Zentrum fur Herz und Kreislauf
  • Medizinische Universitat Tubingen Med. Klinik III, Abt. III fur Kardiologie
  • Reinhard-Nieter-Krankenhaus Med. Klinik 1
  • State Hospital
  • Gottsegen Gyorgy National Institute of Cardiology
  • Szent Imre Hospital, Dept. of Internal MedicineI.
  • Semmelweis University, Dept. of Internal Medicine III.
  • National Institiute of Pulmonology, Dept. of Cardiology
  • Toldi Ferenc Hospital, Dept. of Internal Medicine II.
  • Debrecen City Health Service
  • Markoth Ferenc County Hospital
  • Pandy Kalman Hospital
  • County Hospital, Dept. of Internal Medicine I.
  • Miskolc County Hospital
  • Mosonmagyarovar City Karolina Hospital
  • University of Pecs, Cardiology Clinic
  • Siofok City Hospital
  • Allami Szanatorium
  • Szent Gyorgy Hospital
  • County Hospital, Dept. of Internal Medicine
  • Markusovszky Hospital, Dept. of Internal Medicine III.
  • Divisione di Cardiologia Ospedale Civile
  • Cardiovascular Disease Unit University of Bari-Ploiclinico
  • Azienda Ospedaliera "Garibaldi S, Luigi Ascoli Tomaselli" Servizio di Cardiologia
  • Servizio di Cardiologia Azienda Ospedaliera S. Anna
  • Cardiology Division Hospital "Santa Croce e Carle"
  • Department of Internal Medicine (DIMI) University of Genova
  • Ospedale Civile Umberto I Cardiology Division
  • S. Paolo Hospital University of Milan Department of Cardiology
  • Cardiology Unit University of Naples "Frederico II"
  • Cardiology Unit Policlinico S. Matteo
  • Osp. Civile di Piacenza-Div. di Cardiologia
  • Dep. of Cardiovascular and Respiratory Diseases Policlinico Umberto I
  • Ospedale Umberto I di Torino
  • Catharina Ziekenhuis Afd. Cardilolgie
  • Kennemer Gasthuis
  • Isala Klinieken Locatie De Weezenlanden
  • Academisch Ziekenhuis Maastricht Afdeling Cardiologie
  • Department Cardiology Canisius Wilhelmina Hospital
  • St Elisabeth Ziekenhuis Afdeling Cardiologie
  • Klinika Gastroenterologii i Chorob Wewnetrznych Szpital Wojewodzki Zespolony im. Biziela
  • Oddizial Kardiologii Wojewodzki Szpital Zespolony
  • Samodzielny Publiczny Szpital Kliniczny Klinika Kardiologii
  • I Klinika Chorob Serca Instytut Kardiologii AM
  • Gornoslaskie Centrum Medyczne I Klinika Kardiologii
  • Szpital Wojewodzki Oddzial Kardiologii
  • Instytut Kardiologii CMUJ Klinika Choroby Wiencowej
  • Oddzial Kardilolgii Wojewodski Szpital Specjalistyczny
  • Oddzial Kardiologii Wojewodzkie Centrum Medyczne
  • Oddizial Wewnetzny Szpital Miejski
  • Oddzial Kardiologii Wojewodzki Szpital Zespolony
  • Radomski Szpital Specjalistyczny Oddzial Kardiologii
  • Oddizial Kardiologii Szpital Wojewodzki nr 2
  • Samodzielny Publiczny Szpital Zespolony Oddizial Kardiologii
  • Wojewodzki Szpital Zespolony Oddzial Kardilolgii
  • I Klinika Kardiologii CSK WAM
  • Szpital Wolski im. Dr Anny Gostynskiej Oddzial Kardiologii
  • Instytut Kardiologii
  • Klinika Kardiologii IV Wojskowy Szpital Kliniczny
  • Oddzial Kardiologii Szpital Wojewodzki
  • Cardiology Department, Moscow Clinical Hospital No. 59
  • Res. Inst. of Physical and Chemical Medicine Department of Cardiology Moscow Clinical Hospital No. 29
  • Russian State Medical University Clinical facility: Cardiology Department of City Clinical Hospital No. 4
  • Moscow State Institute of Peace and Friendship Pharmacology Department, Moscow Clinical Hospital #64
  • Cardiology Department Moscow Sechenov Medical Academy
  • Medical Centre of General Management Department of the President of the Russian Federation, Cardiology Department Moscow Clinical Hospital No. 51
  • Medical Centre of General Management Department of the President of the Russian Federation
  • Cardiology Department of State Medical Academy of Postgraduate Education, Myasnikov Clinical Cardiology Research Institute
  • Department of Emergency Cardiology Russian Cardiology Research Centre
  • Moscow State University of Medicine and Stomatolog, Cardiology Department of Moscow Clinical Hospital No. 50
  • Department of Internal Disease No. 5, Moscow State University of Medicine and Stomatology, Cardiology Department Moscow City Hospital No. 11
  • Myocardial Infarction Department St Petersburg Hospital, No. 28
  • Cardiology Department, State Research Institute
  • Cardiology Department Alexandrovskiy Hospital
  • Cardiology Department St Petersburg Hospital No. 2
  • Myocardial Infarction Department St Elizabeth Hospital
  • Cardiology Department St. Petersburg State Pavlov Medical University
  • Myocardial Infarction Department St Petersburg Hodpital, No. 29
  • Cardiology Department, St Petersburg Hospital, No. 15
  • Department of Cardiology No. 3 Pokrovskiy Hospital
  • Hospital Universitari San Juan Servicio di Cardiologia
  • Hospital Valle de Hebron Servicio de Cardiologia
  • Hospital Princeps d'Espanya (Bellvitge) Servicio de cardiologia
  • Hospital Civil De Basurto Cardiology Service
  • Hospital Nuestra Senora de Alarcos Unidad de Medicina Intensiva
  • Hospital Universitario De Getafe Cardiology Service
  • Fundacion Jimenez Diaz Cardiology Service
  • Hospital Clinico Universitario San Carlos Servicio de Cardiologia
  • Hospital La Paz U.M.Q. de cardiologia
  • Hospital de Txagorritxu

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Experimental

Arm Label

1

2

3

Arm Description

placebo tablets

Sotalol

azimilide

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 3, 2002
Last Updated
September 30, 2011
Sponsor
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00035451
Brief Title
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

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
February 2001 (undefined)
Primary Completion Date
June 2003 (Actual)
Study Completion Date
June 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Forest Laboratories

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
658 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
placebo tablets
Arm Title
2
Arm Type
Active Comparator
Arm Description
Sotalol
Arm Title
3
Arm Type
Experimental
Arm Description
azimilide
Intervention Type
Drug
Intervention Name(s)
Azimilide Dihydrochloride
Intervention Description
125 mg azimilide tablets, twice a day for 6 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
tablets, twice daily for 6 months
Intervention Type
Drug
Intervention Name(s)
Sotalol
Intervention Description
160 mg sot twice daily for 6 months
Primary Outcome Measure Information:
Title
To prolong the time to first symptomatic or asymptomatic AFIB, etc event
Time Frame
6 month

10. Eligibility

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

12. IPD Sharing Statement

Learn more about this trial

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

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