Arrhythmia Clinical Trial
Official title:
Efficacy and Safety Evaluation of Azimilide Dihydrochloride in Patients With Implantable Cardioverter Defibrillators
| Verified date | September 2011 |
| Source | Forest Laboratories |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 633 |
| Est. completion date | April 2004 |
| Est. primary completion date | April 2004 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Belgium | A.Z. Sint-Jan, Ruddershove, 10 | Brugge | |
| Belgium | Clin. Univ. UCL de Mont-Godinne- | Yvoir | |
| Canada | University of Alberta Hospital | Edmonton | Alberta |
| Canada | QE II Health Sciences Ctr. | Halifax | Nova Scotia |
| Canada | Hamilton General Hospital/McMaster Clinic | Hamilton | Ontario |
| Canada | Montreal Heart Institute | Montreal | Quebec |
| Canada | Academisch ZiekenhuisRotterdam, Thoraxentrum Dr. Molewaterplein 40 | Rotterdam | Newfoundland and Labrador |
| Canada | Health Sciences Ctr | St Johns | Newfoundland and Labrador |
| Canada | Laval Hospital | Ste-Foy | Quebec |
| Canada | St Michaels Hospital 30 Bond Street 7-050 Queen | Toronto | Ontario |
| Canada | Cardiac Arrythmia Trials/Royal Jubilee Hosp. | Victoria | British Columbia |
| Canada | Winnepeg Health Science Ctr. | Winnepeg | |
| Canada | Isala Klinieken Loc Weezenlanden Afd. Cardiologie Groot Wezenland 20 | Zwolle | Newfoundland and Labrador |
| France | CHRU de Lille-Hopital Cardiologique-Bd du Pr Leclerc | Lille | |
| France | Centre hospitalier L. Pradel-28 av. du doyen Lepine | Lyon | |
| France | Hopital Nord-Chemin Bourrely St Antoine | Marseille | |
| France | CHRU de Nancy-29 av. de Lattre de Tassigny | Nancy | |
| France | CHRU de Nantes-Hopital G. et R. Laennec-bd Jacques Monod | Nantes | |
| France | Hopital Lariboisiere-2 rue A. Pare | Paris | |
| France | Hopital cardiologique du Haut Leveque-av. de Magellan | Pessac | |
| France | CHRU de Rennes-Hotel Dieu-2 rue l'hotel Dieu | Rennes | |
| France | CHRU de TOURS-Hopital TROUSSEAU-Chanbray les Tours | Tours | |
| Germany | Herz-kreislauf-Klinik Bevensen AG Kardiologie Akut Romstedter Str. 25 | Bad Bevensen | |
| Germany | Kerckhoff Klinik Abteilung Elektrophysiologie Benekestr. 2 | Bad Nauheim | |
| Germany | Herzzentrum NRW Kardiologische Ambulanz Georgstr. 11 | Bad Oeynhausen | |
| Germany | Charite Campus Buch Franz-Vollhard-Klinik Wiltbergstr. 50 | Berlin | |
| Germany | Krankenhaus Am Urban Innere Medizin I (Kardiologie) Dieffenbachstr. 1 | Berlin | |
| Germany | Virchow-Klinikum Franz-Volhard-Klinik Wiltbergstr. 50 | Berlin | |
| Germany | Universitatsklinikum Bonn Medizinische Klinik und Poliklinik II Sigmund-Freud-Str. 25 | Bonn | |
| Germany | Stadtisches Klinikum Brandenburg Medizinische Klinik I Kardiologie Hochstr. 29 | Branderburg an der Havel | |
| Germany | Klinikum Coburg Ketschendorferstr. 33 | Coburg | |
| Germany | Evangelische Krankenhaus Abteilung Kardiologie Kirchfeldstr. 40 | Dusseldorf | |
| Germany | Universitatsklinikum Dusseldorf Klinik fur Kardiologie Moorenstr. 5 | Dusseldorf | |
| Germany | Klinikum der Johann-Wolfgang-Goethe-Universitat Medizinische Klinik IV Abteilung Elektrophysiologie Theodor-Stern-Kai 7 | Frankfurt | |
| Germany | Medizinische Universitatsklinik | Freiburg | |
| Germany | Universitats-Krankenhaus Eppendorf Abteilung Kardiologie Martinistr. 52 | Hamburg | |
| Germany | Medizinische Universitats Klinik Heidelberg Medisin III (Kardiologie) Bergheimerstr. 58 | Heidelberg | |
| Germany | Klinikum der Stadt Ludwigshafen Bremserstr. 79 | Ludwigshafen | |
| Germany | Medizinische Universitatsklinik Leipzigerstr. 44 | Magdeburg | |
| Germany | Universitatsklinikum I. Medizinische Klinik Kardiologie/Angiologie/Pneumologie Theodor-Kutzer-Ufer 1-3 | Mannheim | |
| Germany | Deutsches Herzzentrum Minchen Lazarettstr. 36 | Munchen | |
| Germany | Klinikum Grobhadern Universitat Munchen Marchioninistr. 15 | Munchen | |
| Germany | Stadt. Klinikum Nurnberg-Sud Med. Klinik 8-Kardiologie Kardiologie KH II/8 | Nurnberg | |
| Germany | Medizinische Klinik und Poliklinik Universitat Tubingen Ottfried-Muller-Str. 10 | Tubingen | |
| Germany | Klinikum Wuppwrtal GmbH Klinik Fur Herz-und Thoraxchirugie Arrenbergerstr. 20 | Wuppertal | |
| Italy | Istituto di Malattie cardiovasolari policlinico di bari piazza G Cesare 11 | Bari | |
| Italy | Ospedale Maggiore della carita II Divisione di cardiologia, corso mazzini 18 | Novara | |
| Italy | Policlinico Matteo Dippartimento di cardiologia Pizza Golgi, 2 | Pavia | |
| Italy | Divisione di cardiologia Ospedale s. Flippo Neri, Via Martinotti 20 | Roma | |
| Netherlands | Academisch Medisch Centrum Amsterdam Afd. Cardiologie Meibergdreef 9 | Amsterdam | |
| Netherlands | Catharina Ziekenhuis Afd. Cardiologie Postbus 1350 | Eldhoven | |
| Netherlands | Academisch Ziekenhuis Groningen Thoraxcentrum Hanzeplein 1 | Groningen | |
| Netherlands | Leids Universitair Medisch Centrum Afd. Cardiologie Postbus 9600 | Leiden | |
| Netherlands | SintAntonius Ziekenhuis Afd R&D Cardiologie Koekoekslaan 1 | Nieuwegein | |
| Poland | ll Klinika Chorob Serca Akademii Medycznej w Gdansku Kieturakisa 1 | Gdansk | |
| Poland | 1 Klinka kardiologii Slaska Akademia Medyczna, Ziolowa 47 | Katowice | |
| Poland | Oddzial kardiologii-Instut kardiologii, Ul Powstancow | Szczecin | |
| Poland | Instytut Kardiologii Klinika Choroby Wiencowej,ul Spartanka 1 | Warszawa | |
| Poland | Instytut Kardiologii-Klinka Kardiologii Ogolnej, ul. Alpejska 42 | Warszawa | |
| Spain | Hospital Clinic i Provincial, Servicio de Cardiologia, Villarroel, 170 | Barcelona | |
| Spain | Clinica Puerta de Hierro, San Martin de Porres, 4 | Madrid | |
| Spain | Hospital 12 de Octubre, Carretera de Andalucia, km. 5, 4 | Madrid | |
| Spain | Hospital Virgen de la Victoria, Campus Universitario de Teatinos, s/n | Malaga | |
| Spain | Hospital Clinico Universitario de Valencia, Avenida Blasco Ibanez, 17 | Valencia | |
| United States | Mid-Atlantic Cardiovascular Associates | Baltimore | Maryland |
| United States | ATC/Cardio Medical Grp | Beverly Hills | California |
| United States | St Elizabeth Medical Center | Boston | Massachusetts |
| United States | Bridgeport Hospital | Bridgeport | Connecticut |
| United States | Brookdale University Hospital | Brooklyn | New York |
| United States | Lahey Hitchcock Medical Ctr. | Burlington | Massachusetts |
| United States | United HealthNetwork/Ohio Heart Center | Canton | Ohio |
| United States | Medical University of South Carolina | Charleston | South Carolina |
| United States | Mid Carolina Cardiology | Charlotte | North Carolina |
| United States | U. OF Virginia/Dept of Cardiology | Charlottesville | Virginia |
| United States | The Lindnar Clinical Trial Center | Cincinnati | Ohio |
| United States | Cleveland Clinic Foundation | Cleveland | Ohio |
| United States | University Hospitals of Cleveland | Cleveland | Ohio |
| United States | Memorial Hospital | Colorado Springs | Colorado |
| United States | South Carolina Heart Center | Columbia | South Carolina |
| United States | Midwest Cardio Res. Foundation | Columbus | Ohio |
| United States | Heart Place/Baylor University of Medicine | Dallas | Texas |
| United States | UT Southwestern Medical Center at Dallas | Dallas | Texas |
| United States | Dayton Cardiac EP | Dayton | Ohio |
| United States | Doylestown Medical Hospital | Doylestown | Pennsylvania |
| United States | SMDC Education Research | Duluth | Minnesota |
| United States | Duke University Medical Ctr. | Durham | North Carolina |
| United States | Cardiovascular Assoc. | Eugene | Oregon |
| United States | The Cardiovascular Grp./Attn: Mandy Murphy | Fairfax | Virginia |
| United States | Southwest Florida Health Group | Fort Myers | Florida |
| United States | Florida Arrythmia Consultants | Ft Lauderdale | Florida |
| United States | Cardiology Associates of Green Bay | Green Bay | Wisconsin |
| United States | Hershey Med. Ctr.-Div. Cardiology | Hershey | Pennsylvania |
| United States | Baylor College of Medicine | Houston | Texas |
| United States | Huntington Hospital | Huntington | New York |
| United States | University of Iowa Hospital | Iowa City | Iowa |
| United States | Jacksonville Heart Center | Jacksonville | Florida |
| United States | Cardiology Assoc., PC | Johnson City | New York |
| United States | Mid-America Cardiology c/o KU medical Ctr | Kansas City | Kansas |
| United States | The Watson Clinic, LLP | Lakeland | Florida |
| United States | Lancaster Heart Foundation | Lancaster | Pennsylvania |
| United States | Nevada Cardiology | Las Vegas | Nevada |
| United States | UAMS Dept of Cardiology | Little Rock | Arkansas |
| United States | Loma Linda Univ. Med. Ctr. | Loma Linda | California |
| United States | Good Samaritan Hospital | Los Angeles | California |
| United States | VA Greater Los Angeles Healthcare System | Los Angeles | California |
| United States | Louisville Cardiology Medical Group, PSC | Louisville | Kentucky |
| United States | University Cardiology | Louisville | Kentucky |
| United States | Loyola University Med. Ctr. | Maywood | Illinois |
| United States | Tri-City Cardiology Consultants, P.C. | Mesa | Arizona |
| United States | Univ. Miami Jackson Mem. med. Ctr. | MIami | Florida |
| United States | Wisconsin Ctr for Clinical Research | Milwaukee | Wisconsin |
| United States | University of Minnesota-Cardiology | Minneapolis | Minnesota |
| United States | The Heart Group | Mobile | Alabama |
| United States | Morristown Memorial Hospital | Morristown | New Jersey |
| United States | Mid-State Cardiology | Nashville | Tennessee |
| United States | St. Lukes/Roosevelt Hospital Center | New York | New York |
| United States | The Mt Sinai Medical Ctr. | New York | New York |
| United States | Florida Heart Institute | Orlando | Florida |
| United States | Memorial Health Systems/Cardiology Research Associates | ORmond Beach | Florida |
| United States | Atlantic Health Systems | Passaic | New Jersey |
| United States | Blackstone Cardiology Assoc. P.C. | Pawtucket | Rhode Island |
| United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
| United States | Univ of PA/Presbyterian Hospital | Philadelphia | Pennsylvania |
| United States | Barry Alpert, MD, FACC | Pittsburgh | Pennsylvania |
| United States | Maine Cardiology Assoc. | Portland | Maine |
| United States | Medical College of VA | RIchmond | Virginia |
| United States | Rochester Cardiopulmonary Group | Rochester | New York |
| United States | University of Rochester Strong mem. Hospital | Rochester | New York |
| United States | Regional Cardiology Associates | Sacramento | California |
| United States | University of Utah Medical Ctr. | Salt Lake CIty | Utah |
| United States | Cardiac Arrythmia Associates | San Diego | California |
| United States | UCSD Medical Center | San Diego | California |
| United States | LSU Health Sciences Center | Shreveport | Louisiana |
| United States | Inland Cardiology/The Heart Inst. | Spokane | Washington |
| United States | Baystate Medical Center-Cardiology Research | Springfield | Massachusetts |
| United States | Medical College of Ohio | Toledo | Ohio |
| United States | Oklahoma Heart Institute | Tulsa | Oklahoma |
| United States | Washington Hospital Center | Washington | District of Columbia |
| United States | Arrhythmia and Pacemaker Consultants | West Orange | New Jersey |
| United States | Buffalo Cardiology & Pulmonary Assoc. | Williamsville | New York |
| United States | Wake Forest School of Medicine | Winston-Salem | North Carolina |
| United States | University of Mass. Medical Ctr. Division of Cardiovascular Medicine | Worcester | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Forest Laboratories |
United States, Belgium, Canada, France, Germany, Italy, Netherlands, Poland, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Reducing the recurrence of all-cause shocks plus symptomatic ATP | one year | No |
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