Implantable cardioverter defibrillators (ICDs) have been developed to treat ventricular tachycardia or fibrillation (abnormal heart rhythms) by electrical shock or by pacing the heart. ICD therapy is established as highly effective for stopping life-threatening arrhythmias, but it does not preclude the use of anti-arrhythmic drugs for prevention and to decrease the frequency of ICD shocks. The safety and effectiveness of oral azimilide dihydrochloride in reducing the frequency of ICD shocks has been investigated previously in a placebo-controlled study in patients with ICDs. These results need to be confirmed in this larger double-blind, placebo-controlled study with approximately 600 patients.

Condition	Treatment or Intervention	Phase
Arrhythmia	Drug: Azimilide Dihydrochloride	Phase III

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion criteria:

• Currently have an ICD implanted
• Have had a documented episode of symptomatic arrhythmias that triggered a spontaneous ICD shock within 180 days of randomization.
• If the ICD implant is recent, the patient must have had a documented episode of sustained arrhythmias or cardiac arrest within 42 days before implantation of the ICD

Exclusion criteria:

• have severe heart failure
• have a current diagnosis of psychosis
• use illicit drugs
• abuse alcohol
• if female, are currently breast feeding, or plan to become pregnant during the study
• are currently taking antiarrhythmic drugs or other drugs that prolong the QTc interval (a measurement taken from the ECG)
• creatinine >2.5 mg/dL (221 mmol/L)
• potassium <4.0 mEq or >5.5 mEq
• have a neutrophil count (ANC) < 100 mL (low count of a type of white blood cell) at time of randomization
• have 2 or more consecutive QTc values >440 msec

Alabama
      The Heart Group, Mobile,  Alabama,  36608,  United States
Arizona
      Tri-City Cardiology Consultants, P.C., Mesa,  Arizona,  85206,  United States
Arkansas
      UAMS Dept of Cardiology, Little Rock,  Arkansas,  72205,  United States
California
      UCSD Medical Center, San Diego,  California,  92103,  United States
      Good Samaritan Hospital, Los Angeles,  California,  90017,  United States
      ATC/Cardio Medical Grp, Beverly Hills,  California,  90210,  United States
      Cardiac Arrythmia Associates, San Diego,  California,  92037,  United States
      Regional Cardiology Associates, Sacramento,  California,  95819,  United States
      Loma Linda Univ. Med. Ctr., Loma Linda,  California,  92354,  United States
      VA Greater Los Angeles Healthcare System, Los Angeles,  California,  90073,  United States
Colorado
      Memorial Hospital, Colorado Springs,  Colorado,  80910,  United States
Connecticut
      Bridgeport Hospital, Bridgeport,  Connecticut,  06610,  United States
District of Columbia
      Washington Hospital Center, Washington,  District of Columbia,  20010,  United States
Florida
      Memorial Health Systems/Cardiology Research Associates, Ormond Beach,  Florida,  32174,  United States
      The Watson Clinic, LLP, Lakeland,  Florida,  33805,  United States
      Florida Arrythmia Consultants, Ft. Lauderdale,  Florida,  33308,  United States
      Southwest Florida Health Group, Fort Myers,  Florida,  33919,  United States
      Univ. Miami Jackson Mem. med. Ctr., Miami,  Florida,  33136,  United States
      Jacksonville Heart Center, Jacksonville,  Florida,  32250,  United States
      Florida Heart Institute, Orlando,  Florida,  32803,  United States
Illinois
      Loyola University Med. Ctr., Maywood,  Illinois,  60153,  United States
Iowa
      University of Iowa Hospital, Iowa City,  Iowa,  52242,  United States
Kansas
      Mid-America Cardiology c/o KU medical Ctr, Kansas City,  Kansas,  66160,  United States
Kentucky
      Louisville Cardiology Medical Group, PSC, Louisville,  Kentucky,  40207,  United States
      University Cardiology, Louisville,  Kentucky,  40202,  United States
Louisiana
      LSU Health Sciences Center, Shreveport,  Louisiana,  71130,  United States
Maine
      Maine Cardiology Assoc., Portland,  Maine,  04102,  United States
Maryland
      Mid-Atlantic Cardiovascular Associates, Baltimore,  Maryland,  21204,  United States
Massachusetts
      Baystate Medical Center-Cardiology Research, Springfield,  Massachusetts,  01199,  United States
      St Elizabeth Medical Center, Boston,  Massachusetts,  02135,  United States
      Lahey Hitchcock Medical Ctr., Burlington,  Massachusetts,  01805,  United States
      University of Mass. Medical Ctr. Division of Cardiovascular Medicine, Worcester,  Massachusetts,  01655,  United States
Minnesota
      University of Minnesota-Cardiology, Minneapolis,  Minnesota,  55455,  United States
      SMDC Education Research, Duluth,  Minnesota,  55805,  United States
Nevada
      Nevada Cardiology, Las Vegas,  Nevada,  89109,  United States
New Jersey
      Arrhythmia and Pacemaker Consultants, West Orange,  New Jersey,  07052,  United States
      Atlantic Health Systems, Passaic,  New Jersey,  07055,  United States
      Morristown Memorial Hospital, Morristown,  New Jersey,  07962,  United States
New York
      University of Rochester Strong mem. Hospital, Rochester,  New York,  14642,  United States
      The Mt Sinai Medical Ctr., New York,  New York,  10029,  United States
      Brookdale University Hospital, Brooklyn,  New York,  111212,  United States
      Rochester Cardiopulmonary Group, Rochester,  New York,  14621,  United States
      Huntington Hospital, Huntington,  New York,  11743,  United States
      Buffalo Cardiology & Pulmonary Assoc., Williamsville,  New York,  14221,  United States
      Cardiology Assoc., PC, Johnson City,  New York,  13797,  United States
      St. Lukes/Roosevelt Hospital Center, New York,  New York,  10025,  United States
North Carolina
      Duke University Medical Ctr., Durham,  North Carolina,  27710,  United States
      Mid Carolina Cardiology, Charlotte,  North Carolina,  28204,  United States
      Wake Forest School of Medicine, Winston Salem,  North Carolina,  27157,  United States
Ohio
      University Hospitals of Cleveland, Cleveland,  Ohio,  44106,  United States
      The Lindnar Clinical Trial Center, Cincinnati,  Ohio,  45219,  United States
      Midwest Cardio Res. Foundation, Columbus,  Ohio,  43214,  United States
      Medical College of Ohio, Toledo,  Ohio,  43614,  United States
      United HealthNetwork/Ohio Heart Center, Canton,  Ohio,  44718,  United States
      Cleveland Clinic Foundation, Cleveland,  Ohio,  44195,  United States
      Dayton Cardiac EP, Dayton,  Ohio,  45406,  United States
Oklahoma
      Oklahoma Heart Institute, Tulsa,  Oklahoma,  74104,  United States
Oregon
      Cardiovascular Assoc., Eugene,  Oregon,  97401,  United States
Pennsylvania
      Barry Alpert, MD, FACC, Pittsburgh,  Pennsylvania,  15224,  United States
      Thomas Jefferson University, Philadelphia,  Pennsylvania,  19107,  United States
      Univ of PA/Presbyterian Hospital, Philadelphia,  Pennsylvania,  19104,  United States
      Doylestown Medical Hospital, Doylestown,  Pennsylvania,  18901,  United States
      Hershey Med. Ctr.-Div. Cardiology, Hershey,  Pennsylvania,  17033,  United States
      Lancaster Heart Foundation, Lancaster,  Pennsylvania,  17603,  United States
Rhode Island
      Blackstone Cardiology Assoc. P.C., Pawtucket,  Rhode Island,  02860,  United States
South Carolina
      South Carolina Heart Center, Columbia,  South Carolina,  29204,  United States
      Medical University of South Carolina, Charleston,  South Carolina,  29425,  United States
Tennessee
      Mid-State Cardiology, Nashville,  Tennessee,  37203,  United States
Texas
      UT Southwestern Medical Center at Dallas, Dallas,  Texas,  75390-9047,  United States
      Baylor College of Medicine, Houston,  Texas,  77030,  United States
      Heart Place/Baylor University of Medicine, Dallas,  Texas,  75246,  United States
Utah
      University of Utah Medical Ctr., Salt Lake City,  Utah,  84132,  United States
Virginia
      U. OF Virginia/Dept of Cardiology, Charlottesville,  Virginia,  22908,  United States
      Medical College of VA, Richmond,  Virginia,  23219,  United States
      The Cardiovascular Grp./Attn: Mandy Murphy, Fairfax,  Virginia,  22031,  United States
Washington
      Inland Cardiology/The Heart Inst., Spokane,  Washington,  99204,  United States
Wisconsin
      Cardiology Associates of Green Bay, Green Bay,  Wisconsin,  54301,  United States
      Wisconsin Ctr for Clinical Research, Milwaukee,  Wisconsin,  53215,  United States
Belgium
      Clin. Univ. UCL de Mont-Godinne-, Yvoir,  5530,  Belgium
      A.Z. Sint-Jan, Ruddershove, 10, Brugge,  8000,  Belgium
Canada
      Winnepeg Health Science Ctr., Winnepeg,  R3E 0Z3,  Canada
Canada, Alberta
      University of Alberta Hospital, Edmonton,  Alberta,  T6G-2B7,  Canada
Canada, British Columbia
      Cardiac Arrythmia Trials/Royal Jubilee Hosp., Victoria,  British Columbia,  V8R-4R2,  Canada
Canada, Newfoundland and Labrador
      Health Sciences Ctr, St. Johns,  Newfoundland and Labrador,  A1B-3V6,  Canada
      Academisch ZiekenhuisRotterdam, Thoraxentrum Dr. Molewaterplein 40, Rotterdam,  Newfoundland and Labrador,  3015 GD,  Canada
      Isala Klinieken Loc Weezenlanden Afd. Cardiologie Groot Wezenland 20, Zwolle,  Newfoundland and Labrador,  8011JW,  Canada
Canada, Nova Scotia
      QE II Health Sciences Ctr., Halifax,  Nova Scotia,  B3K-3A7,  Canada
Canada, Ontario
      St Michaels Hospital 30 Bond Street 7-050 Queen, Toronto,  Ontario,  M5B-1W8,  Canada
      Hamilton General Hospital/McMaster Clinic, Hamilton,  Ontario,  L8L-2X2,  Canada
Canada, Quebec
      Montreal Heart Institute, Montreal,  Quebec,  H1T 1C8,  Canada
      Laval Hospital, Ste Foy,  Quebec,  G1V-4G5,  Canada
France
      Hopital Nord-Chemin Bourrely St Antoine, Marseille,  CEDEX 20 13915,  France
      CHRU de Nancy-29 av. de Lattre de Tassigny, Nancy,  CEDEX 54 035,  France
      Hopital cardiologique du Haut Leveque-av. de Magellan, Pessac,  CEDEX-33 604,  France
      Hopital Lariboisiere-2 rue A. Pare, Paris,  CEDEX 75010,  France
      CHRU de Rennes-Hotel Dieu-2 rue l'hotel Dieu, Rennes,  CEDEX 35 033,  France
      CHRU de TOURS-Hopital TROUSSEAU-Chanbray les Tours, Tours,  CEDEX-37044,  France
      CHRU de Lille-Hopital Cardiologique-Bd du Pr Leclerc, Lille,  CEDEX 59 037-,  France
      CHRU de Nantes-Hopital G. et R. Laennec-bd Jacques Monod, Nantes,  CEDEX 44 093,  France
      Centre hospitalier L. Pradel-28 av. du doyen Lepine, Lyon,  CEDEX 3-69 394,  France
Germany
      Universitatsklinikum I. Medizinische Klinik Kardiologie/Angiologie/Pneumologie Theodor-Kutzer-Ufer 1-3, Mannheim,  68135,  Germany
      Krankenhaus Am Urban Innere Medizin I (Kardiologie) Dieffenbachstr. 1, Berlin,  10967,  Germany
      Klinikum Coburg Ketschendorferstr. 33, Coburg,  96450,  Germany
      Virchow-Klinikum Franz-Volhard-Klinik Wiltbergstr. 50, Berlin,  13125,  Germany
      Stadt. Klinikum Nurnberg-Sud Med. Klinik 8-Kardiologie Kardiologie KH II/8, Nurnberg,  90471,  Germany
      Klinikum Wuppwrtal GmbH Klinik Fur Herz-und Thoraxchirugie Arrenbergerstr. 20, Wuppertal,  42117,  Germany
      Klinikum Grobhadern Universitat Munchen Marchioninistr. 15, Munchen,  81377,  Germany
      Klinikum der Johann-Wolfgang-Goethe-Universitat Medizinische Klinik IV Abteilung Elektrophysiologie Theodor-Stern-Kai 7, Frankfurt,  M. 60590,  Germany
      Medizinische Universitatsklinik Leipzigerstr. 44, Magdeburg,  39120,  Germany
      Medizinische Klinik und Poliklinik Universitat Tubingen Ottfried-Muller-Str. 10, Tubingen,  72076,  Germany
      Universitatsklinikum Bonn Medizinische Klinik und Poliklinik II Sigmund-Freud-Str. 25, Bonn,  53105,  Germany
      Universitats-Krankenhaus Eppendorf Abteilung Kardiologie Martinistr. 52, Hamburg,  20246,  Germany
      Herz-kreislauf-Klinik Bevensen AG Kardiologie Akut Romstedter Str. 25, Bad Bevensen,  29549,  Germany
      Stadtisches Klinikum Brandenburg Medizinische Klinik I Kardiologie Hochstr. 29, Branderburg an der Havel,  14770,  Germany
      Universitatsklinikum Dusseldorf Klinik fur Kardiologie Moorenstr. 5, Dusseldorf,  40225,  Germany
      Kerckhoff Klinik Abteilung Elektrophysiologie Benekestr. 2, Bad Nauheim,  61230,  Germany
      Deutsches Herzzentrum Minchen Lazarettstr. 36, Munchen,  80636,  Germany
      Medizinische Universitats Klinik Heidelberg Medisin III (Kardiologie) Bergheimerstr. 58, Heidelberg,  69115,  Germany
      Klinikum der Stadt Ludwigshafen Bremserstr. 79, Ludwigshafen,  67063,  Germany
      Charite Campus Buch Franz-Vollhard-Klinik Wiltbergstr. 50, Berlin,  13125,  Germany
      Evangelische Krankenhaus Abteilung Kardiologie Kirchfeldstr. 40, Dusseldorf,  40217,  Germany
      Herzzentrum NRW Kardiologische Ambulanz Georgstr. 11, Bad Oeynhausen,  32545,  Germany
      Medizinische Universitatsklinik, Freiburg,  79106,  Germany
Italy
      Divisione di cardiologia Ospedale s. Flippo Neri, Via Martinotti 20, Roma,  168,  Italy
      Ospedale Maggiore della carita II Divisione di cardiologia, corso mazzini 18, Novara,  28100,  Italy
      Istituto di Malattie cardiovasolari policlinico di bari piazza G Cesare 11, Bari,  70120,  Italy
      Policlinico Matteo Dippartimento di cardiologia Pizza Golgi, 2, Pavia,  27100,  Italy
Netherlands
      SintAntonius Ziekenhuis Afd R&D Cardiologie Koekoekslaan 1, Nieuwegein,  3435CM,  Netherlands
      Leids Universitair Medisch Centrum Afd. Cardiologie Postbus 9600, Leiden,  2300 RC,  Netherlands
      Catharina Ziekenhuis Afd. Cardiologie Postbus 1350, Eldhoven,  5602ZA,  Netherlands
      Academisch Ziekenhuis Groningen Thoraxcentrum Hanzeplein 1, Groningen,  9713GZ,  Netherlands
      Academisch Medisch Centrum Amsterdam Afd. Cardiologie Meibergdreef 9, Amsterdam,  1105AZ,  Netherlands
Poland
      Instytut Kardiologii-Klinka Kardiologii Ogolnej, ul. Alpejska 42, Warszawa,  04628,  Poland
      1 Klinka kardiologii Slaska Akademia Medyczna, Ziolowa 47, Katowice,  40 635,  Poland
      Oddzial kardiologii-Instut kardiologii, Ul Powstancow, Szczecin,  70111,  Poland
      Instytut Kardiologii Klinika Choroby Wiencowej,ul Spartanka 1, Warszawa,  02637,  Poland
      ll Klinika Chorob Serca Akademii Medycznej w Gdansku Kieturakisa 1, Gdansk,  80742,  Poland
Spain
      Hospital Clinic i Provincial, Servicio de Cardiologia, Villarroel, 170, Barcelona,  8036,  Spain
      Hospital Virgen de la Victoria, Campus Universitario de Teatinos, s/n, Malaga,  29010,  Spain
      Hospital 12 de Octubre, Carretera de Andalucia, km. 5, 4, Madrid,  28041,  Spain
      Clinica Puerta de Hierro, San Martin de Porres, 4, Madrid,  28035,  Spain
      Hospital Clinico Universitario de Valencia, Avenida Blasco Ibanez, 17, Valencia,  46010,  Spain

Study ID Numbers:  2000098
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  May 3, 2002
ClinicalTrials.gov Identifier:  NCT00035490
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08