Full Text View
Tabular View
No Study Results Posted
Related Studies
Efficacy and Safety Evaluation of Azimilide or Sotalol vs Placebo for Treatment of Patients With Atrial Fibrillation.
This study has been completed.
First Received: May 3, 2002   Last Updated: July 17, 2009   History of Changes
Sponsor: Procter and Gamble
Information provided by: Procter and Gamble
ClinicalTrials.gov Identifier: NCT00035451
  Purpose

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.


Condition Intervention Phase
Atrial Fibrillation
Drug: Azimilide Dihydrochloride
Drug: Placebo
Drug: Sotalol
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Efficacy and Safety Evaluation of Azimilide or Sotalol vs Placebo for Treatment of Patients With Atrial Fibrillation.

Resource links provided by NLM:


Further study details as provided by Procter and Gamble:

Primary Outcome Measures:
  • To prolong the time to first symptomatic or asymptomatic AFIB, etc event [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Enrollment: 658
Study Start Date: February 2001
Study Completion Date: June 2003
Primary Completion Date: June 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Placebo Comparator
placebo tablets
Drug: Placebo
tablets, twice daily for 6 months
2: Active Comparator
Sotalol
Drug: Sotalol
160 mg sot twice daily for 6 months
3: Experimental
azimilide
Drug: Azimilide Dihydrochloride
125 mg azimilide tablets, twice a day for 6 months

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00035451

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

No publications provided

Responsible Party: Procter & Gamble Pharmaceuticals ( Paloma Cuenca, MD )
Study ID Numbers: 1999105
Study First Received: May 3, 2002
Last Updated: July 17, 2009
ClinicalTrials.gov Identifier: NCT00035451     History of Changes
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sympatholytics
Neurotransmitter Agents
Heart Diseases
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Calcium Channel Blockers
Cardiovascular Agents
Pharmacologic Actions
Sotalol
Azimilide
Membrane Transport Modulators
Pathologic Processes
Autonomic Agents
Therapeutic Uses
Adrenergic beta-Antagonists
Cardiovascular Diseases
Adrenergic Antagonists
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Atrial Fibrillation
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on November 27, 2009