Efficacy and Safety Evaluation of Azimilide Dihydrochloride in Patients With Implantable Cardioverter Defibrillators

PHASE3CompletedINTERVENTIONAL
Enrollment

633

Participants

Timeline

Start Date

September 30, 2001

Primary Completion Date

April 30, 2004

Study Completion Date

April 30, 2004

Conditions
Arrhythmia
Interventions
DRUG

Azimilide Dihydrochloride

125 mg azimilide, once a day for one year

DRUG

placebo

placebo tablet, once daily for one year

DRUG

Azimilide Dihydrochloride

75 mg azimilide, once a day for one year

Trial Locations (142)

168

Divisione di cardiologia Ospedale s. Flippo Neri, Via Martinotti 20, Roma

5530

Clin. Univ. UCL de Mont-Godinne-, Yvoir

8000

A.Z. Sint-Jan, Ruddershove, 10, Bruges

8036

Hospital Clinic i Provincial, Servicio de Cardiologia, Villarroel, 170, Barcelona

10025

St. Lukes/Roosevelt Hospital Center, New York

10029

The Mt Sinai Medical Ctr., New York

10967

Krankenhaus Am Urban Innere Medizin I (Kardiologie) Dieffenbachstr. 1, Berlin

11743

Huntington Hospital, Huntington

13125

Charite Campus Buch Franz-Vollhard-Klinik Wiltbergstr. 50, Berlin

Virchow-Klinikum Franz-Volhard-Klinik Wiltbergstr. 50, Berlin

13797

Cardiology Assoc., PC, Johnson City

14221

Buffalo Cardiology & Pulmonary Assoc., Williamsville

14621

Rochester Cardiopulmonary Group, Rochester

14642

University of Rochester Strong mem. Hospital, Rochester

14770

Stadtisches Klinikum Brandenburg Medizinische Klinik I Kardiologie Hochstr. 29, Branderburg An Der Havel

15224

Barry Alpert, MD, FACC, Pittsburgh

17033

Hershey Med. Ctr.-Div. Cardiology, Hershey

17603

Lancaster Heart Foundation, Lancaster

18901

Doylestown Medical Hospital, Doylestown

19104

Univ of PA/Presbyterian Hospital, Philadelphia

19107

Thomas Jefferson University, Philadelphia

20010

Washington Hospital Center, Washington D.C.

20246

Universitats-Krankenhaus Eppendorf Abteilung Kardiologie Martinistr. 52, Hamburg

21204

Mid-Atlantic Cardiovascular Associates, Baltimore

22031

The Cardiovascular Grp./Attn: Mandy Murphy, Fairfax

22908

U. OF Virginia/Dept of Cardiology, Charlottesville

23219

Medical College of VA, Richmond

27100

Policlinico Matteo Dippartimento di cardiologia Pizza Golgi, 2, Pavia

27157

Wake Forest School of Medicine, Winston-Salem

27710

Duke University Medical Ctr., Durham

28035

Clinica Puerta de Hierro, San Martin de Porres, 4, Madrid

28041

Hospital 12 de Octubre, Carretera de Andalucia, km. 5, 4, Madrid

28100

Ospedale Maggiore della carita II Divisione di cardiologia, corso mazzini 18, Novara

28204

Mid Carolina Cardiology, Charlotte

29010

Hospital Virgen de la Victoria, Campus Universitario de Teatinos, s/n, Málaga

29204

South Carolina Heart Center, Columbia

29425

Medical University of South Carolina, Charleston

29549

Herz-kreislauf-Klinik Bevensen AG Kardiologie Akut Romstedter Str. 25, Bad Bevensen

32174

Memorial Health Systems/Cardiology Research Associates, Ormond Beach

32250

Jacksonville Heart Center, Jacksonville

32545

Herzzentrum NRW Kardiologische Ambulanz Georgstr. 11, Bad Oeynhausen

32803

Florida Heart Institute, Orlando

33136

Univ. Miami Jackson Mem. med. Ctr., Miami

33308

Florida Arrythmia Consultants, Fort Lauderdale

33805

The Watson Clinic, LLP, Lakeland

33919

Southwest Florida Health Group, Fort Myers

36608

The Heart Group, Mobile

37203

Mid-State Cardiology, Nashville

39120

Medizinische Universitatsklinik Leipzigerstr. 44, Magdeburg

40202

University Cardiology, Louisville

40207

Louisville Cardiology Medical Group, PSC, Louisville

40217

Evangelische Krankenhaus Abteilung Kardiologie Kirchfeldstr. 40, Düsseldorf

40225

Universitatsklinikum Dusseldorf Klinik fur Kardiologie Moorenstr. 5, Düsseldorf

42117

Klinikum Wuppwrtal GmbH Klinik Fur Herz-und Thoraxchirugie Arrenbergerstr. 20, Wuppertal

43214

Midwest Cardio Res. Foundation, Columbus

43614

Medical College of Ohio, Toledo

44106

University Hospitals of Cleveland, Cleveland

44195

Cleveland Clinic Foundation, Cleveland

44718

United HealthNetwork/Ohio Heart Center, Canton

45219

The Lindnar Clinical Trial Center, Cincinnati

45406

Dayton Cardiac EP, Dayton

46010

Hospital Clinico Universitario de Valencia, Avenida Blasco Ibanez, 17, Valencia

52242

University of Iowa Hospital, Iowa City

53105

Universitatsklinikum Bonn Medizinische Klinik und Poliklinik II Sigmund-Freud-Str. 25, Bonn

53215

Wisconsin Ctr for Clinical Research, Milwaukee

54301

Cardiology Associates of Green Bay, Green Bay

55455

University of Minnesota-Cardiology, Minneapolis

55805

SMDC Education Research, Duluth

60153

Loyola University Med. Ctr., Maywood

61230

Kerckhoff Klinik Abteilung Elektrophysiologie Benekestr. 2, Bad Nauheim

66160

Mid-America Cardiology c/o KU medical Ctr, Kansas City

67063

Klinikum der Stadt Ludwigshafen Bremserstr. 79, Ludwigshafen

68135

Universitatsklinikum I. Medizinische Klinik Kardiologie/Angiologie/Pneumologie Theodor-Kutzer-Ufer 1-3, Mannheim

69115

Medizinische Universitats Klinik Heidelberg Medisin III (Kardiologie) Bergheimerstr. 58, Heidelberg

70111

Oddzial kardiologii-Instut kardiologii, Ul Powstancow, Szczecin

70120

Istituto di Malattie cardiovasolari policlinico di bari piazza G Cesare 11, Bari

71130

LSU Health Sciences Center, Shreveport

72076

Medizinische Klinik und Poliklinik Universitat Tubingen Ottfried-Muller-Str. 10, Tübingen

72205

UAMS Dept of Cardiology, Little Rock

74104

Oklahoma Heart Institute, Tulsa

75246

Heart Place/Baylor University of Medicine, Dallas

77030

Baylor College of Medicine, Houston

79106

Medizinische Universitatsklinik, Freiburg im Breisgau

80636

Deutsches Herzzentrum Minchen Lazarettstr. 36, München

80742

ll Klinika Chorob Serca Akademii Medycznej w Gdansku Kieturakisa 1, Gdansk

80910

Memorial Hospital, Colorado Springs

81377

Klinikum Grobhadern Universitat Munchen Marchioninistr. 15, München

84132

University of Utah Medical Ctr., Salt Lake City

85206

Tri-City Cardiology Consultants, P.C., Mesa

89109

Nevada Cardiology, Las Vegas

90017

Good Samaritan Hospital, Los Angeles

90073

VA Greater Los Angeles Healthcare System, Los Angeles

90210

ATC/Cardio Medical Grp, Beverly Hills

90471

Stadt. Klinikum Nurnberg-Sud Med. Klinik 8-Kardiologie Kardiologie KH II/8, Nuremberg

92037

Cardiac Arrythmia Associates, San Diego

92103

UCSD Medical Center, San Diego

92354

Loma Linda Univ. Med. Ctr., Loma Linda

95819

Regional Cardiology Associates, Sacramento

96450

Klinikum Coburg Ketschendorferstr. 33, Coburg

97401

Cardiovascular Assoc., Eugene

99204

Inland Cardiology/The Heart Inst., Spokane

111212

Brookdale University Hospital, Brooklyn

06610

Bridgeport Hospital, Bridgeport

04102

Maine Cardiology Assoc., Portland

02135

St Elizabeth Medical Center, Boston

01805

Lahey Hitchcock Medical Ctr., Burlington

01199

Baystate Medical Center-Cardiology Research, Springfield

01655

University of Mass. Medical Ctr. Division of Cardiovascular Medicine, Worcester

07962

Morristown Memorial Hospital, Morristown

07055

Atlantic Health Systems, Passaic

07052

Arrhythmia and Pacemaker Consultants, West Orange

02860

Blackstone Cardiology Assoc. P.C., Pawtucket

75390-9047

UT Southwestern Medical Center at Dallas, Dallas

T6G-2B7

University of Alberta Hospital, Edmonton

V8R-4R2

Cardiac Arrythmia Trials/Royal Jubilee Hosp., Victoria

3015 GD

Academisch ZiekenhuisRotterdam, Thoraxentrum Dr. Molewaterplein 40, Rotterdam

A1B-3V6

Health Sciences Ctr, St. John's

8011JW

Isala Klinieken Loc Weezenlanden Afd. Cardiologie Groot Wezenland 20, Zwolle

B3K-3A7

QE II Health Sciences Ctr., Halifax

L8L-2X2

Hamilton General Hospital/McMaster Clinic, Hamilton

M5B-1W8

St Michaels Hospital 30 Bond Street 7-050 Queen, Toronto

H1T 1C8

Montreal Heart Institute, Montreal

G1V-4G5

Laval Hospital, Ste-Foy

R3E 0Z3

Winnepeg Health Science Ctr., Winnepeg

CEDEX 59 037-

CHRU de Lille-Hopital Cardiologique-Bd du Pr Leclerc, Lille

CEDEX 3-69 394

Centre hospitalier L. Pradel-28 av. du doyen Lepine, Lyon

CEDEX 20 13915

Hopital Nord-Chemin Bourrely St Antoine, Marseille

CEDEX 54 035

CHRU de Nancy-29 av. de Lattre de Tassigny, Nancy

CEDEX 44 093

CHRU de Nantes-Hopital G. et R. Laennec-bd Jacques Monod, Nantes

CEDEX 75010

Hopital Lariboisiere-2 rue A. Pare, Paris

CEDEX-33 604

Hopital cardiologique du Haut Leveque-av. de Magellan, Pessac

CEDEX 35 033

CHRU de Rennes-Hotel Dieu-2 rue l'hotel Dieu, Rennes

CEDEX-37044

CHRU de TOURS-Hopital TROUSSEAU-Chanbray les Tours, Tours

M. 60590

Klinikum der Johann-Wolfgang-Goethe-Universitat Medizinische Klinik IV Abteilung Elektrophysiologie Theodor-Stern-Kai 7, Frankfurt

1105AZ

Academisch Medisch Centrum Amsterdam Afd. Cardiologie Meibergdreef 9, Amsterdam

5602ZA

Catharina Ziekenhuis Afd. Cardiologie Postbus 1350, Eldhoven

9713GZ

Academisch Ziekenhuis Groningen Thoraxcentrum Hanzeplein 1, Groningen

2300 RC

Leids Universitair Medisch Centrum Afd. Cardiologie Postbus 9600, Leiden

3435CM

SintAntonius Ziekenhuis Afd R&D Cardiologie Koekoekslaan 1, Nieuwegein

40 635

1 Klinka kardiologii Slaska Akademia Medyczna, Ziolowa 47, Katowice

02637

Instytut Kardiologii Klinika Choroby Wiencowej,ul Spartanka 1, Warsaw

04628

Instytut Kardiologii-Klinka Kardiologii Ogolnej, ul. Alpejska 42, Warsaw

Sponsors
All Listed Sponsors
lead

Forest Laboratories

INDUSTRY