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

• Sponsor: Forest Laboratories (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00035451
• Collaborator: (none)
• Enrollment: 658
• Locations: 129
• Arms: 3
• Duration (Months): 27.9
• Patients Per Site: 5.1
• Patients Per Site Per Month: 0.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Drug: Azimilide Dihydrochloride; Drug: Placebo; Drug: Sotalol	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 658 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety Evaluation of Azimilide or Sotalol vs Placebo for Treatment of Patients With Atrial Fibrillation.
• Study Start Date: Feb 1, 2001
• Actual Primary Completion Date: Jun 1, 2003
• Actual Study Completion Date: Jun 1, 2003

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. To prolong the time to first symptomatic or asymptomatic AFIB, etc event [6 month]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

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

Sponsors and Collaborators

• Forest Laboratories

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Forest Laboratories
• ClinicalTrials.gov Identifier: NCT00035451
• Other Study ID Numbers: 1999105
• First Posted: May 6, 2002
• Last Update Posted: Oct 3, 2011
• Last Verified: Sep 1, 2011

• Additional relevant MeSH terms: Atrial Fibrillation; Sotalol; Azimilide

Study Results

No Results Posted as of Oct 3, 2011