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| 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. |
| 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 |
Inclusion criteria:
Exclusion criteria:
Contacts and Locations
Hide Study 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 | |
| Study Director: | Paloma Cuenca, MD | Procter and Gamble |
More Information
| 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 |
|
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 |