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Efficacy and Safety Evaluation of Azimilide or Sotalol vs placebo for Treatment of Patients With Atrial Fibrillation. Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Efficacy and Safety Evaluation of Azimilide or Sotalol vs placebo for Treatment of Patients With Atrial Fibrillation. conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Efficacy and Safety Evaluation of Azimilide or Sotalol vs placebo for Treatment of Patients With Atrial Fibrillation. Clinical research trials and Efficacy and Safety Evaluation of Azimilide or Sotalol vs placebo for Treatment of Patients With Atrial Fibrillation. health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Efficacy and Safety Evaluation of Azimilide or Sotalol vs placebo for Treatment of Patients With Atrial Fibrillation.. Efficacy and Safety Evaluation of Azimilide or Sotalol vs placebo for Treatment of Patients With Atrial Fibrillation. Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Efficacy and Safety Evaluation of Azimilide or Sotalol vs placebo for Treatment of Patients With Atrial Fibrillation. clinical trial. Human subjects frequently get the finest healthcare available for their Efficacy and Safety Evaluation of Azimilide or Sotalol vs placebo for Treatment of Patients With Atrial Fibrillation. condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "E" Clinical Trials Conditions > Efficacy and Safety Evaluation of Azimilide or Sotalol vs placebo for Treatment of Patients With Atrial Fibrillation.  Efficacy and Safety Evaluation of Azimilide or Sotalol vs placebo for Treatment of Patients With Atrial Fibrillation.
Efficacy and Safety Evaluation of Azimilide or Sotalol vs placebo for Treatment of Patients With Atrial Fibrillation.
For Condition: Atrial Fibrillation
Status: Completed
Sponsor(s): Procter & Gamble Pharmaceuticals ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/80 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 657
Location and Contact Information:
County Hospital, Dept. of Internal Medicine I.
Kecskemet, , 6000
Hungary
Cardiologie/Pavillon Baudot Centre Hospitalier Universitaire Purpan
Toulouse, , 31059
France
Hospital Princeps d'Espanya (Bellvitge) Servicio de cardiologia
Barcelona, , 08907
Spain
Miskolc County Hospital
Miskolc, , 3562
Hungary
Gornoslaskie Centrum Medyczne I Klinika Kardiologii
Katowice, , 40-635
Poland
Academisch Ziekenhuis Maastricht Afdeling Cardiologie
Maastricht, , 6229
Netherlands
Moscow State University of Medicine and Stomatolog, Cardiology Department of Moscow Clinical Hospital No. 50
Moscow, , 125206
Russian Federation
Samodzielny Publiczny Szpital Kliniczny Klinika Kardiologii
Bialystok, , 15-276
Poland
Medical Centre of General Management Department of the President of the Russian Federation, Cardiology Department Moscow Clinical Hospital No. 51
Moscow, , 121309
Russian Federation
Franz-Volhard-Klinik Abteilung fur Elektrophysiologie
Berlin, , 13125
Germany
Gottsegen Gyorgy National Institute of Cardiology
Budapest, , 1096
Hungary
Kennemer Gasthuis
Haarlem, , 2035
Netherlands
Myocardial Infarction Department St Petersburg Hodpital, No. 29
St Petersburg, , 197022
Russian Federation
Klinikum Erfurt GmbH
Erfurt, , 99012
Germany
Osp. Civile di Piacenza-Div. di Cardiologia
Piacenza, , 29100
Italy
Catharina Ziekenhuis Afd. Cardilolgie
Eindhoven, , 5623
Netherlands
Department of Cardiology No. 3 Pokrovskiy Hospital
St Petersburg, , 199106
Russian Federation
Hospital de Txagorritxu
Vitoria, , 01009
Spain
Kerckhhoff-Klinik Abteilung Klinische Pharmakologie
Bad Nauheim, , 61231
Germany
Klinika Gastroenterologii i Chorob Wewnetrznych Szpital Wojewodzki Zespolony im. Biziela
Ul Ujejskiego 75, Bydgoszcz, 85-168
Poland
Allami Szanatorium
Sopron, , 9400
Hungary
Oddzial Kardiologii Szpital Wojewodzki
Zamosc, , 22-400
Poland
Clinique Generale Saint Jean Service de cardiologie
Brussels, , 1000
Belgium
Hospital Universitari San Juan Servicio di Cardiologia
Alicante, , 03550
Spain
Cardiologie Hopital Jean Rostand
Ivry-sur-Seine, , 94205
France
S. Paolo Hospital University of Milan Department of Cardiology
Milano, , 20142
Italy
Hospital Universitario De Getafe Cardiology Service
Getafe, , 28905
Spain
Krankenhaus Duren Medizinische Klinik I Kardiologie/Angiologie
Dueren, , 52351
Germany
Dep. of Cardiovascular and Respiratory Diseases Policlinico Umberto I
Roma, , 00161
Italy
Klinikum der Stadt Ludwigshafen Abteilung fur Elektrophysiologie der Kardiologie/Herzzentrum
Ludwigshafen, , 67063
Germany
Szpital Wolski im. Dr Anny Gostynskiej Oddzial Kardiologii
Warszawa, , 02-211
Poland
Universitate zu Koeln Klinik III fur Innere Medizin
Koeln (Lindenthal), , 50924
Germany
Fundacion Jimenez Diaz Cardiology Service
Madrid, , 28040
Spain
Russian State Medical University Clinical facility: Cardiology Department of City Clinical Hospital No. 4
Moscow, , 113096
Russian Federation
Myocardial Infarction Department St Petersburg Hospital, No. 28
St Petersburg, , 190000
Russian Federation
Centre Hospitalier General Hospital De Girac
St Michel, , 16470
France
St Elisabeth Ziekenhuis Afdeling Cardiologie
Tilburg, , 5022
Netherlands
Hospital Valle de Hebron Servicio de Cardiologia
Barcelona, , 08035
Spain
Cardiology Unit Policlinico S. Matteo
Pavia, , 27100
Italy
Erzgebirgskrankenhaus Klinik fur Innere Medizin
Annaberg, , 09456
Germany
Hopital Gavriel Montpied Cardiologie-Maladie cardiovascularies
Clermont-Ferrand, , 63000
France
Cardiology Department, Moscow Clinical Hospital No. 59
Moscow, , 103030
Russian Federation
Service de Cardiologie A Hopital Cardiologique
Lille, , 59037
France
Medizinische Universitat Tubingen Med. Klinik III, Abt. III fur Kardiologie
Tuebingen, , 72076
Germany
Kardiologie Herzzentrum Osnabruck
Bad Rothenfelde, , 49214
Germany
Ospedale Umberto I di Torino
Torino, , 10128
Italy
Hospital Civil De Basurto Cardiology Service
Basurto-Bilbao, , 48013
Spain
Service de Cardiologie et Maladies Vascularies CHRU Pontchaillou
Rennes, , 35000
France
Hospital Universitarie Erasme
Brussels, , 1000
Belgium
Reinhard-Nieter-Krankenhaus Med. Klinik 1
Wilhelmshafen, , 26389
Germany
Klinikum Coburg II Med. Klinik
Coburg, , 96450
Germany
Medizinische Universitats-und Ploiklinik Innere Medizin 3
Homburg, , 66421
Germany
Oddizial Kardiologii Szpital Wojewodzki nr 2
Rzeszow, , 35-301
Poland
Klinik am See REHA-Zentrum fur Herz und Kreislauf
Ruedersdorf, , 15562
Germany
Service de cardiologie Hopitaux de Brabois/CHRU Nancy
Vandoeuvre-les-Nancy, , 54511
France
Cardiology Department Moscow Sechenov Medical Academy
Moscow, , 119881
Russian Federation
Cardiology Division Hospital "Santa Croce e Carle"
Cuneo, , 12100
Italy
Siofok City Hospital
Siofok, , 8601
Hungary
Isala Klinieken Locatie De Weezenlanden
JW Zwolle, , 8011
Netherlands
State Hospital
Balatonfured, , 8230
Hungary
Azienda Ospedaliera "Garibaldi S, Luigi Ascoli Tomaselli" Servizio di Cardiologia
Catania, , 95100
Italy
Markoth Ferenc County Hospital
Eger, , 3301
Hungary
National Institiute of Pulmonology, Dept. of Cardiology
Budapest, , 1529
Hungary
Service de Cardiologie Hopital Saint Philibert
Lomme, , 59160
France
Ospedale Civile Umberto I Cardiology Division
Mestre, , 30170
Italy
Universitatsklinikum Heidelberg
Heidelberg, , 69115
Germany
Cardiology Unit University of Naples "Frederico II"
Napoli, , 80131
Italy
Szent Imre Hospital, Dept. of Internal MedicineI.
Budapest, , 1115
Hungary
Pandy Kalman Hospital
Gyula, , 5700
Hungary
Wojewodzki Szpital Zespolony Oddzial Kardilolgii
Torun, , 87-100
Poland
Service de Cardilolgie CH du Pays d'Aix
Aix-en-Provence, , 13616
France
Semmelweis University, Dept. of Internal Medicine III.
Budapest, , 1125
Hungary
Cardiology Department St. Petersburg State Pavlov Medical University
St Petersburg, , 197022
Russian Federation
Hospital La Paz U.M.Q. de cardiologia
Madrid, , 28046
Spain
Oddizial Wewnetzny Szpital Miejski
Ostrowiec Swietokrzyski, , 27-400
Poland
Medizinische Klinik und Poliklinik Innere Medizin C
Munster, , D-48149
Germany
Cardiology Department, St Petersburg Hospital, No. 15
St Petersburg, , 198205
Russian Federation
Myocardial Infarction Department St Elizabeth Hospital
St Petersburg, , 195257
Russian Federation
Samodzielny Publiczny Szpital Zespolony Oddizial Kardiologii
Szczecin, , 71-455
Poland
Stadisches Klinikum Brandenburg Med-Klinik I/Kardiologie Pulmologie und Angiologie
Brandenburg, , 14770
Germany
Res. Inst. of Physical and Chemical Medicine Department of Cardiology Moscow Clinical Hospital No. 29
Moscow, , 111020
Russian Federation
Medizinische Klinik und Poliklnik Innere Medizin C
Mannheim, , 68167
Germany
Cardiologie CHRU St Etienne/Hopital Nord
Saint-Etienne, , 42055
France
Oddzial Kardiologii Wojewodzki Szpital Zespolony
Plock, , 09-400
Poland
Medizinische Hochschule Innere Medizin/Abt. fur Kardiologie
Hannover, , 30625
Germany
Department of Internal Medicine (DIMI) University of Genova
Genova, , 16132
Italy
Universitatsklinikum Hamburg-Eppendork Klinik und Poliklinik fur Innere Medizin Abteilung Kardiologie
Hamburg, , 20246
Germany
Medical Centre of General Management Department of the President of the Russian Federation
Moscow, , 121356
Russian Federation
Szent Gyorgy Hospital
Szekesfehervar, , 8000
Hungary
Cardiologie A CHU Rangueil
Toulouse, , 31403
France
Hospital Clinico Universitario San Carlos Servicio de Cardiologia
Madrid, , 28040
Spain
Oddzial Kardilolgii Wojewodski Szpital Specjalistyczny
Olsztyn, , 10-561
Poland
Service de Cardiologie CHRU
Grenoble, , 38046
France
Cardiology Department Alexandrovskiy Hospital
St Petersburg, , 193318
Russian Federation
Service de Cardiologie Hopital Lariboisiere
Paris, , 75010
France
Department of Emergency Cardiology Russian Cardiology Research Centre
Moscow, , 121552
Russian Federation
University of Pecs, Cardiology Clinic
Pecs, , 7621
Hungary
Moscow State Institute of Peace and Friendship Pharmacology Department, Moscow Clinical Hospital #64
Moscow, , 117292
Russian Federation
Dr. Schreiber Krankenhaus Neukoelin 1 Innere Rudowerstrasse, 48
Berlin, , 12351
Germany
Medizinische Universitaetsklinik Innere Medizin III Kardiologie und Angiologie
Frieburg, , 79016
Germany
Cardiology Department, State Research Institute
St Petersburg, , 192242
Russian Federation
Department Cardiology Canisius Wilhelmina Hospital
Nijmegen, , 6532
Netherlands
CHR Besancon Service de cardiologie
Besancon, , 25030
France
Cardiology Department St Petersburg Hospital No. 2
St Petersburg, , 194354
Russian Federation
Cardilolgie Hopital Guillaume et Rene Laennec
Nantes, , 44093
France
County Hospital, Dept. of Internal Medicine
Szentes, , 6601
Hungary
Servizio di Cardiologia Azienda Ospedaliera S. Anna
Como, , 22100
Italy
Szpital Wojewodzki Oddzial Kardiologii
Kielce, , 25-736
Poland
Oddizial Kardiologii Wojewodzki Szpital Zespolony
Ul Ujejskiego 75, Bydgoszcz, 85-168
Poland
Cardiovascular Disease Unit University of Bari-Ploiclinico
Bari, , 70124
Italy
Instytut Kardiologii CMUJ Klinika Choroby Wiencowej
Krakow, , 31-202
Poland
Markusovszky Hospital, Dept. of Internal Medicine III.
Szombathely, , 9700
Hungary
Hospital Nuestra Senora de Alarcos Unidad de Medicina Intensiva
Ciudad Real, , 13002
Spain
Divisione di Cardiologia Ospedale Civile
Asti, , 14100
Italy
Cardiology Department of State Medical Academy of Postgraduate Education, Myasnikov Clinical Cardiology Research Institute
Moscow, , 121552
Russian Federation
Department of Internal Disease No. 5, Moscow State University of Medicine and Stomatology, Cardiology Department Moscow City Hospital No. 11
Moscow, , 127018
Russian Federation
Instytut Kardiologii
Warszawa, , 04-268
Poland
Cliniques Univeristaires UCL Mont-Godinne Avenue Theresse 1
Yvoir, , 5530
Belgium
Klinika Kardiologii IV Wojskowy Szpital Kliniczny
Wroclaw, , 50-981
Poland
Radomski Szpital Specjalistyczny Oddzial Kardiologii
Radom, , 26-600
Poland
Klinikum Kassel Medizinische Klinik II
Kassel, , 34125
Germany
Toldi Ferenc Hospital, Dept. of Internal Medicine II.
Cegled, , 2700
Hungary
Klinkum Lippe-Detmold Med. Klink II-Kardiologie
Detmold, , 32756
Germany
Debrecen City Health Service
Debrecen, , 4032
Hungary
I Klinika Chorob Serca Instytut Kardiologii AM
Gdansk, , 80-211
Poland
Oddzial Kardiologii Wojewodzkie Centrum Medyczne
Opole, , 45-418
Poland
Universitat Leipzig Medizinische Klinik und Poliklinik 1 Abteilung fur Kardiologie and Angiolgie
Leipzig, , 04103
Germany
Mosonmagyarovar City Karolina Hospital
Mosonmagyarovar, , 9200
Hungary
I Klinika Kardiologii CSK WAM
Warszawa, , 00-909
Poland
Additional Information:
Study ID Numbers: 1999105;
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00035451
Other Atrial Fibrillation Studies:
1. Efficacy and Safety of Azimilide in the Prophylactic Treatment of Patients With Atrial Fibrillation.
2. Efficacy and Safety Evaluation of Azimilide or Sotalol vs placebo for Treatment of Patients With Atrial Fibrillation.
3. Compare the effects of amiodarone, sotalol, and placebo in maintaining sinus rhythm in patients with atrial fibrillation converted to sinus rhythm
4. Epidemiology of Symptomatic Arrhythmias
5. A safety and efficacy trial evaluating the use of SanOrg34006 compared to warfarin or acenocoumarol in patients with atrial fibrillation
Related Studies:
Other Atrial Fibrillation Clinical Trials
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Efficacy and Safety Evaluation of Azimilide or Sotalol vs placebo for Treatment of Patients With Atrial Fibrillation.
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