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| Sponsor: | Procter and Gamble |
|---|---|
| Information provided by: | Procter and Gamble |
| ClinicalTrials.gov Identifier: | NCT00035490 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Arrhythmia |
Drug: Azimilide Dihydrochloride Drug: placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Efficacy and Safety Evaluation of Azimilide Dihydrochloride in Patients With Implantable Cardioverter Defibrillators |
| Enrollment: | 633 |
| Study Start Date: | September 2001 |
| Study Completion Date: | April 2004 |
| Primary Completion Date: | April 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Placebo Comparator
Placebo tablets
|
Drug: placebo
placebo tablet, once daily for one year
|
|
2: Experimental
75 mg azimilide
|
Drug: Azimilide Dihydrochloride
75 mg azimilide, once a day for one year
|
|
3: Experimental
125 mg azimilide
|
Drug: Azimilide Dihydrochloride
125 mg azimilide, once a day for one year
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| The Heart Group | |
| Mobile, Alabama, United States, 36608 | |
| United States, Arizona | |
| Tri-City Cardiology Consultants, P.C. | |
| Mesa, Arizona, United States, 85206 | |
| United States, Arkansas | |
| UAMS Dept of Cardiology | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| UCSD Medical Center | |
| San Diego, California, United States, 92103 | |
| Regional Cardiology Associates | |
| Sacramento, California, United States, 95819 | |
| ATC/Cardio Medical Grp | |
| Beverly Hills, California, United States, 90210 | |
| Cardiac Arrythmia Associates | |
| San Diego, California, United States, 92037 | |
| Good Samaritan Hospital | |
| Los Angeles, California, United States, 90017 | |
| Loma Linda Univ. Med. Ctr. | |
| Loma Linda, California, United States, 92354 | |
| VA Greater Los Angeles Healthcare System | |
| Los Angeles, California, United States, 90073 | |
| United States, Colorado | |
| Memorial Hospital | |
| Colorado Springs, Colorado, United States, 80910 | |
| United States, Connecticut | |
| Bridgeport Hospital | |
| Bridgeport, Connecticut, United States, 06610 | |
| United States, District of Columbia | |
| Washington Hospital Center | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Florida | |
| Southwest Florida Health Group | |
| Fort Myers, Florida, United States, 33919 | |
| The Watson Clinic, LLP | |
| Lakeland, Florida, United States, 33805 | |
| Florida Arrythmia Consultants | |
| Ft Lauderdale, Florida, United States, 33308 | |
| Memorial Health Systems/Cardiology Research Associates | |
| ORmond Beach, Florida, United States, 32174 | |
| Univ. Miami Jackson Mem. med. Ctr. | |
| MIami, Florida, United States, 33136 | |
| Jacksonville Heart Center | |
| jacksonville, Florida, United States, 32250 | |
| Florida Heart Institute | |
| Orlando, Florida, United States, 32803 | |
| United States, Illinois | |
| Loyola University Med. Ctr. | |
| Maywood, Illinois, United States, 60153 | |
| United States, Iowa | |
| University of Iowa Hospital | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Kansas | |
| Mid-America Cardiology c/o KU medical Ctr | |
| Kansas City, Kansas, United States, 66160 | |
| United States, Kentucky | |
| Louisville Cardiology Medical Group, PSC | |
| Louisville, Kentucky, United States, 40207 | |
| University Cardiology | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Louisiana | |
| LSU Health Sciences Center | |
| Shreveport, Louisiana, United States, 71130 | |
| United States, Maine | |
| Maine Cardiology Assoc. | |
| Portland, Maine, United States, 04102 | |
| United States, Maryland | |
| Mid-Atlantic Cardiovascular Associates | |
| Baltimore, Maryland, United States, 21204 | |
| United States, Massachusetts | |
| Baystate Medical Center-Cardiology Research | |
| Springfield, Massachusetts, United States, 01199 | |
| St Elizabeth Medical Center | |
| Boston, Massachusetts, United States, 02135 | |
| Lahey Hitchcock Medical Ctr. | |
| Burlington, Massachusetts, United States, 01805 | |
| University of Mass. Medical Ctr. Division of Cardiovascular Medicine | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, Minnesota | |
| University of Minnesota-Cardiology | |
| Minneapolis, Minnesota, United States, 55455 | |
| SMDC Education Research | |
| Duluth, Minnesota, United States, 55805 | |
| United States, Nevada | |
| Nevada Cardiology | |
| Las Vegas, Nevada, United States, 89109 | |
| United States, New Jersey | |
| Arrhythmia and Pacemaker Consultants | |
| West Orange, New Jersey, United States, 07052 | |
| Atlantic Health Systems | |
| Passaic, New Jersey, United States, 07055 | |
| Morristown Memorial Hospital | |
| Morristown, New Jersey, United States, 07962 | |
| United States, New York | |
| University of Rochester Strong mem. Hospital | |
| Rochester, New York, United States, 14642 | |
| The Mt Sinai Medical Ctr. | |
| New York, New York, United States, 10029 | |
| Buffalo Cardiology & Pulmonary Assoc. | |
| Williamsville, New York, United States, 14221 | |
| Rochester Cardiopulmonary Group | |
| Rochester, New York, United States, 14621 | |
| Huntington Hospital | |
| Huntington, New York, United States, 11743 | |
| Brookdale University Hospital | |
| Brooklyn, New York, United States, 111212 | |
| Cardiology Assoc., PC | |
| Johnson City, New York, United States, 13797 | |
| St. Lukes/Roosevelt Hospital Center | |
| New York, New York, United States, 10025 | |
| United States, North Carolina | |
| Duke University Medical Ctr. | |
| Durham, North Carolina, United States, 27710 | |
| Mid Carolina Cardiology | |
| Charlotte, North Carolina, United States, 28204 | |
| Wake Forest School of Medicine | |
| Winston-Salem, North Carolina, United States, 27157 | |
| United States, Ohio | |
| Medical College of Ohio | |
| Toledo, Ohio, United States, 43614 | |
| The Lindnar Clinical Trial Center | |
| Cincinnati, Ohio, United States, 45219 | |
| Midwest Cardio Res. Foundation | |
| Columbus, Ohio, United States, 43214 | |
| University Hospitals of Cleveland | |
| Cleveland, Ohio, United States, 44106 | |
| United HealthNetwork/Ohio Heart Center | |
| Canton, Ohio, United States, 44718 | |
| Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States, 44195 | |
| Dayton Cardiac EP | |
| Dayton, Ohio, United States, 45406 | |
| United States, Oklahoma | |
| Oklahoma Heart Institute | |
| Tulsa, Oklahoma, United States, 74104 | |
| United States, Oregon | |
| Cardiovascular Assoc. | |
| Eugene, Oregon, United States, 97401 | |
| United States, Pennsylvania | |
| Doylestown Medical Hospital | |
| Doylestown, Pennsylvania, United States, 18901 | |
| Thomas Jefferson University | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Univ of PA/Presbyterian Hospital | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Barry Alpert, MD, FACC | |
| Pittsburgh, Pennsylvania, United States, 15224 | |
| Hershey Med. Ctr.-Div. Cardiology | |
| Hershey, Pennsylvania, United States, 17033 | |
| Lancaster Heart Foundation | |
| Lancaster, Pennsylvania, United States, 17603 | |
| United States, Rhode Island | |
| Blackstone Cardiology Assoc. P.C. | |
| Pawtucket, Rhode Island, United States, 02860 | |
| United States, South Carolina | |
| South Carolina Heart Center | |
| Columbia, South Carolina, United States, 29204 | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| United States, Tennessee | |
| Mid-State Cardiology | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| UT Southwestern Medical Center at Dallas | |
| Dallas, Texas, United States, 75390-9047 | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| Heart Place/Baylor University of Medicine | |
| Dallas, Texas, United States, 75246 | |
| United States, Utah | |
| University of Utah Medical Ctr. | |
| Salt Lake CIty, Utah, United States, 84132 | |
| United States, Virginia | |
| U. OF Virginia/Dept of Cardiology | |
| Charlottesville, Virginia, United States, 22908 | |
| Medical College of VA | |
| RIchmond, Virginia, United States, 23219 | |
| The Cardiovascular Grp./Attn: Mandy Murphy | |
| Fairfax, Virginia, United States, 22031 | |
| United States, Washington | |
| Inland Cardiology/The Heart Inst. | |
| Spokane, Washington, United States, 99204 | |
| United States, Wisconsin | |
| Cardiology Associates of Green Bay | |
| Green Bay, Wisconsin, United States, 54301 | |
| Wisconsin Ctr for Clinical Research | |
| Milwaukee, Wisconsin, United States, 53215 | |
| Belgium | |
| Clin. Univ. UCL de Mont-Godinne- | |
| Yvoir, Belgium, 5530 | |
| A.Z. Sint-Jan, Ruddershove, 10 | |
| Brugge, Belgium, 8000 | |
| Canada | |
| Winnepeg Health Science Ctr. | |
| Winnepeg, Canada, R3E 0Z3 | |
| Canada, Alberta | |
| University of Alberta Hospital | |
| Edmonton, Alberta, Canada, T6G-2B7 | |
| Canada, British Columbia | |
| Cardiac Arrythmia Trials/Royal Jubilee Hosp. | |
| Victoria, British Columbia, Canada, V8R-4R2 | |
| Canada, Newfoundland and Labrador | |
| Health Sciences Ctr | |
| St Johns, Newfoundland and Labrador, Canada, A1B-3V6 | |
| Academisch ZiekenhuisRotterdam, Thoraxentrum Dr. Molewaterplein 40 | |
| Rotterdam, Newfoundland and Labrador, Canada, 3015 GD | |
| Isala Klinieken Loc Weezenlanden Afd. Cardiologie Groot Wezenland 20 | |
| Zwolle, Newfoundland and Labrador, Canada, 8011JW | |
| Canada, Nova Scotia | |
| QE II Health Sciences Ctr. | |
| Halifax, Nova Scotia, Canada, B3K-3A7 | |
| Canada, Ontario | |
| St Michaels Hospital 30 Bond Street 7-050 Queen | |
| Toronto, Ontario, Canada, M5B-1W8 | |
| Hamilton General Hospital/McMaster Clinic | |
| Hamilton, Ontario, Canada, L8L-2X2 | |
| Canada, Quebec | |
| Montreal Heart Institute | |
| Montreal, Quebec, Canada, H1T 1C8 | |
| Laval Hospital | |
| Ste-Foy, Quebec, Canada, G1V-4G5 | |
| France | |
| Hopital Nord-Chemin Bourrely St Antoine | |
| Marseille, France, CEDEX 20 13915 | |
| CHRU de Nancy-29 av. de Lattre de Tassigny | |
| Nancy, France, CEDEX 54 035 | |
| Hopital cardiologique du Haut Leveque-av. de Magellan | |
| Pessac, France, CEDEX-33 604 | |
| CHRU de Lille-Hopital Cardiologique-Bd du Pr Leclerc | |
| Lille, France, CEDEX 59 037- | |
| CHRU de Rennes-Hotel Dieu-2 rue l'hotel Dieu | |
| Rennes, France, CEDEX 35 033 | |
| CHRU de TOURS-Hopital TROUSSEAU-Chanbray les Tours | |
| Tours, France, CEDEX-37044 | |
| Hopital Lariboisiere-2 rue A. Pare | |
| Paris, France, CEDEX 75010 | |
| CHRU de Nantes-Hopital G. et R. Laennec-bd Jacques Monod | |
| Nantes, France, CEDEX 44 093 | |
| Centre hospitalier L. Pradel-28 av. du doyen Lepine | |
| Lyon, France, CEDEX 3-69 394 | |
| Germany | |
| Universitatsklinikum I. Medizinische Klinik Kardiologie/Angiologie/Pneumologie Theodor-Kutzer-Ufer 1-3 | |
| Mannheim, Germany, 68135 | |
| Krankenhaus Am Urban Innere Medizin I (Kardiologie) Dieffenbachstr. 1 | |
| Berlin, Germany, 10967 | |
| Klinikum Coburg Ketschendorferstr. 33 | |
| Coburg, Germany, 96450 | |
| Klinikum Grobhadern Universitat Munchen Marchioninistr. 15 | |
| Munchen, Germany, 81377 | |
| Stadt. Klinikum Nurnberg-Sud Med. Klinik 8-Kardiologie Kardiologie KH II/8 | |
| Nurnberg, Germany, 90471 | |
| Klinikum Wuppwrtal GmbH Klinik Fur Herz-und Thoraxchirugie Arrenbergerstr. 20 | |
| Wuppertal, Germany, 42117 | |
| Virchow-Klinikum Franz-Volhard-Klinik Wiltbergstr. 50 | |
| Berlin, Germany, 13125 | |
| Klinikum der Johann-Wolfgang-Goethe-Universitat Medizinische Klinik IV Abteilung Elektrophysiologie Theodor-Stern-Kai 7 | |
| Frankfurt, Germany, M. 60590 | |
| Medizinische Universitatsklinik Leipzigerstr. 44 | |
| Magdeburg, Germany, 39120 | |
| Medizinische Klinik und Poliklinik Universitat Tubingen Ottfried-Muller-Str. 10 | |
| Tubingen, Germany, 72076 | |
| Universitatsklinikum Bonn Medizinische Klinik und Poliklinik II Sigmund-Freud-Str. 25 | |
| Bonn, Germany, 53105 | |
| Universitats-Krankenhaus Eppendorf Abteilung Kardiologie Martinistr. 52 | |
| Hamburg, Germany, 20246 | |
| Kerckhoff Klinik Abteilung Elektrophysiologie Benekestr. 2 | |
| Bad Nauheim, Germany, 61230 | |
| Stadtisches Klinikum Brandenburg Medizinische Klinik I Kardiologie Hochstr. 29 | |
| Branderburg an der Havel, Germany, 14770 | |
| Universitatsklinikum Dusseldorf Klinik fur Kardiologie Moorenstr. 5 | |
| Dusseldorf, Germany, 40225 | |
| Herz-kreislauf-Klinik Bevensen AG Kardiologie Akut Romstedter Str. 25 | |
| Bad Bevensen, Germany, 29549 | |
| Deutsches Herzzentrum Minchen Lazarettstr. 36 | |
| Munchen, Germany, 80636 | |
| Medizinische Universitats Klinik Heidelberg Medisin III (Kardiologie) Bergheimerstr. 58 | |
| Heidelberg, Germany, 69115 | |
| Klinikum der Stadt Ludwigshafen Bremserstr. 79 | |
| Ludwigshafen, Germany, 67063 | |
| Charite Campus Buch Franz-Vollhard-Klinik Wiltbergstr. 50 | |
| Berlin, Germany, 13125 | |
| Evangelische Krankenhaus Abteilung Kardiologie Kirchfeldstr. 40 | |
| Dusseldorf, Germany, 40217 | |
| Herzzentrum NRW Kardiologische Ambulanz Georgstr. 11 | |
| Bad Oeynhausen, Germany, 32545 | |
| Medizinische Universitatsklinik | |
| Freiburg, Germany, 79106 | |
| Italy | |
| Divisione di cardiologia Ospedale s. Flippo Neri, Via Martinotti 20 | |
| Roma, Italy, 168 | |
| Ospedale Maggiore della carita II Divisione di cardiologia, corso mazzini 18 | |
| Novara, Italy, 28100 | |
| Istituto di Malattie cardiovasolari policlinico di bari piazza G Cesare 11 | |
| Bari, Italy, 70120 | |
| Policlinico Matteo Dippartimento di cardiologia Pizza Golgi, 2 | |
| Pavia, Italy, 27100 | |
| Netherlands | |
| SintAntonius Ziekenhuis Afd R&D Cardiologie Koekoekslaan 1 | |
| Nieuwegein, Netherlands, 3435CM | |
| Leids Universitair Medisch Centrum Afd. Cardiologie Postbus 9600 | |
| Leiden, Netherlands, 2300 RC | |
| Catharina Ziekenhuis Afd. Cardiologie Postbus 1350 | |
| Eldhoven, Netherlands, 5602ZA | |
| Academisch Ziekenhuis Groningen Thoraxcentrum Hanzeplein 1 | |
| Groningen, Netherlands, 9713GZ | |
| Academisch Medisch Centrum Amsterdam Afd. Cardiologie Meibergdreef 9 | |
| Amsterdam, Netherlands, 1105AZ | |
| Poland | |
| Instytut Kardiologii-Klinka Kardiologii Ogolnej, ul. Alpejska 42 | |
| Warszawa, Poland, 04628 | |
| 1 Klinka kardiologii Slaska Akademia Medyczna, Ziolowa 47 | |
| Katowice, Poland, 40 635 | |
| Oddzial kardiologii-Instut kardiologii, Ul Powstancow | |
| Szczecin, Poland, 70111 | |
| Instytut Kardiologii Klinika Choroby Wiencowej,ul Spartanka 1 | |
| Warszawa, Poland, 02637 | |
| ll Klinika Chorob Serca Akademii Medycznej w Gdansku Kieturakisa 1 | |
| Gdansk, Poland, 80742 | |
| Spain | |
| Hospital Clinic i Provincial, Servicio de Cardiologia, Villarroel, 170 | |
| Barcelona, Spain, 8036 | |
| Hospital Clinico Universitario de Valencia, Avenida Blasco Ibanez, 17 | |
| Valencia, Spain, 46010 | |
| Hospital 12 de Octubre, Carretera de Andalucia, km. 5, 4 | |
| Madrid, Spain, 28041 | |
| Clinica Puerta de Hierro, San Martin de Porres, 4 | |
| Madrid, Spain, 28035 | |
| Hospital Virgen de la Victoria, Campus Universitario de Teatinos, s/n | |
| Malaga, Spain, 29010 | |
| Study Director: | Jose M Brum, MD | Procter and Gamble |
More Information
| Responsible Party: | Procter & Gamble Pharmaceuticals ( Jose Brum, MD ) |
| Study ID Numbers: | 2000098 |
| Study First Received: | May 3, 2002 |
| Last Updated: | July 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00035490 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Membrane Transport Modulators Pathologic Processes Heart Diseases Molecular Mechanisms of Pharmacological Action Therapeutic Uses Calcium Channel Blockers |
Cardiovascular Diseases Cardiovascular Agents Anti-Arrhythmia Agents Pharmacologic Actions Azimilide Arrhythmias, Cardiac |
