Efficacy and Safety Evaluation of Azimilide Dihydrochloride in Patients With Implantable Cardioverter Defibrillators
- Registration Number
- NCT00035490
- Lead Sponsor
- Forest Laboratories
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 633
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 placebo Placebo tablets 2 Azimilide Dihydrochloride 75 mg azimilide 3 Azimilide Dihydrochloride 125 mg azimilide
- Primary Outcome Measures
Name Time Method Reducing the recurrence of all-cause shocks plus symptomatic ATP one year
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (142)
Bridgeport Hospital
🇺🇸Bridgeport, Connecticut, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
LSU Health Sciences Center
🇺🇸Shreveport, Louisiana, United States
Morristown Memorial Hospital
🇺🇸Morristown, New Jersey, United States
Arrhythmia and Pacemaker Consultants
🇺🇸West Orange, New Jersey, United States
Health Sciences Ctr
🇨🇦St Johns, Newfoundland and Labrador, Canada
Mid-Atlantic Cardiovascular Associates
🇺🇸Baltimore, Maryland, United States
University Hospitals of Cleveland
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Univ of PA/Presbyterian Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Heart Place/Baylor University of Medicine
🇺🇸Dallas, Texas, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Laval Hospital
🇨🇦Ste-Foy, Quebec, Canada
The Heart Group
🇺🇸Mobile, Alabama, United States
Tri-City Cardiology Consultants, P.C.
🇺🇸Mesa, Arizona, United States
ATC/Cardio Medical Grp
🇺🇸Beverly Hills, California, United States
Loyola University Med. Ctr.
🇺🇸Maywood, Illinois, United States
SMDC Education Research
🇺🇸Duluth, Minnesota, United States
VA Greater Los Angeles Healthcare System
🇺🇸Los Angeles, California, United States
St Elizabeth Medical Center
🇺🇸Boston, Massachusetts, United States
The Mt Sinai Medical Ctr.
🇺🇸New York, New York, United States
Southwest Florida Health Group
🇺🇸Fort Myers, Florida, United States
Brookdale University Hospital
🇺🇸Brooklyn, New York, United States
University of Mass. Medical Ctr. Division of Cardiovascular Medicine
🇺🇸Worcester, Massachusetts, United States
Rochester Cardiopulmonary Group
🇺🇸Rochester, New York, United States
Dayton Cardiac EP
🇺🇸Dayton, Ohio, United States
Midwest Cardio Res. Foundation
🇺🇸Columbus, Ohio, United States
St. Lukes/Roosevelt Hospital Center
🇺🇸New York, New York, United States
UAMS Dept of Cardiology
🇺🇸Little Rock, Arkansas, United States
Good Samaritan Hospital
🇺🇸Los Angeles, California, United States
Hershey Med. Ctr.-Div. Cardiology
🇺🇸Hershey, Pennsylvania, United States
Memorial Hospital
🇺🇸Colorado Springs, Colorado, United States
Loma Linda Univ. Med. Ctr.
🇺🇸Loma Linda, California, United States
Winnepeg Health Science Ctr.
🇨🇦Winnepeg, Canada
Baystate Medical Center-Cardiology Research
🇺🇸Springfield, Massachusetts, United States
Jacksonville Heart Center
🇺🇸Jacksonville, Florida, United States
University of Iowa Hospital
🇺🇸Iowa City, Iowa, United States
Cardiology Assoc., PC
🇺🇸Johnson City, New York, United States
South Carolina Heart Center
🇺🇸Columbia, South Carolina, United States
Florida Arrythmia Consultants
🇺🇸Ft Lauderdale, Florida, United States
Virchow-Klinikum Franz-Volhard-Klinik Wiltbergstr. 50
🇩🇪Berlin, Germany
Barry Alpert, MD, FACC
🇺🇸Pittsburgh, Pennsylvania, United States
CHRU de Lille-Hopital Cardiologique-Bd du Pr Leclerc
🇫🇷Lille, France
University of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada
Cardiac Arrythmia Trials/Royal Jubilee Hosp.
🇨🇦Victoria, British Columbia, Canada
Buffalo Cardiology & Pulmonary Assoc.
🇺🇸Williamsville, New York, United States
UT Southwestern Medical Center at Dallas
🇺🇸Dallas, Texas, United States
Cardiovascular Assoc.
🇺🇸Eugene, Oregon, United States
Hopital Lariboisiere-2 rue A. Pare
🇫🇷Paris, France
Isala Klinieken Loc Weezenlanden Afd. Cardiologie Groot Wezenland 20
🇨🇦Zwolle, Newfoundland and Labrador, Canada
Montreal Heart Institute
🇨🇦Montreal, Quebec, Canada
Blackstone Cardiology Assoc. P.C.
🇺🇸Pawtucket, Rhode Island, United States
Hopital cardiologique du Haut Leveque-av. de Magellan
🇫🇷Pessac, France
Oklahoma Heart Institute
🇺🇸Tulsa, Oklahoma, United States
Herz-kreislauf-Klinik Bevensen AG Kardiologie Akut Romstedter Str. 25
🇩🇪Bad Bevensen, Germany
Charite Campus Buch Franz-Vollhard-Klinik Wiltbergstr. 50
🇩🇪Berlin, Germany
QE II Health Sciences Ctr.
🇨🇦Halifax, Nova Scotia, Canada
Herzzentrum NRW Kardiologische Ambulanz Georgstr. 11
🇩🇪Bad Oeynhausen, Germany
A.Z. Sint-Jan, Ruddershove, 10
🇧🇪Brugge, Belgium
Clin. Univ. UCL de Mont-Godinne-
🇧🇪Yvoir, Belgium
St Michaels Hospital 30 Bond Street 7-050 Queen
🇨🇦Toronto, Ontario, Canada
Hamilton General Hospital/McMaster Clinic
🇨🇦Hamilton, Ontario, Canada
Krankenhaus Am Urban Innere Medizin I (Kardiologie) Dieffenbachstr. 1
🇩🇪Berlin, Germany
U. OF Virginia/Dept of Cardiology
🇺🇸Charlottesville, Virginia, United States
Universitats-Krankenhaus Eppendorf Abteilung Kardiologie Martinistr. 52
🇩🇪Hamburg, Germany
Universitatsklinikum Bonn Medizinische Klinik und Poliklinik II Sigmund-Freud-Str. 25
🇩🇪Bonn, Germany
Klinikum Coburg Ketschendorferstr. 33
🇩🇪Coburg, Germany
Centre hospitalier L. Pradel-28 av. du doyen Lepine
🇫🇷Lyon, France
Kerckhoff Klinik Abteilung Elektrophysiologie Benekestr. 2
🇩🇪Bad Nauheim, Germany
Hospital 12 de Octubre, Carretera de Andalucia, km. 5, 4
🇪🇸Madrid, Spain
Mid-America Cardiology c/o KU medical Ctr
🇺🇸Kansas City, Kansas, United States
Hopital Nord-Chemin Bourrely St Antoine
🇫🇷Marseille, France
CHRU de TOURS-Hopital TROUSSEAU-Chanbray les Tours
🇫🇷Tours, France
Duke University Medical Ctr.
🇺🇸Durham, North Carolina, United States
The Lindnar Clinical Trial Center
🇺🇸Cincinnati, Ohio, United States
University of Minnesota-Cardiology
🇺🇸Minneapolis, Minnesota, United States
Nevada Cardiology
🇺🇸Las Vegas, Nevada, United States
Cardiac Arrythmia Associates
🇺🇸San Diego, California, United States
University of Utah Medical Ctr.
🇺🇸Salt Lake CIty, Utah, United States
UCSD Medical Center
🇺🇸San Diego, California, United States
Mid-State Cardiology
🇺🇸Nashville, Tennessee, United States
Wisconsin Ctr for Clinical Research
🇺🇸Milwaukee, Wisconsin, United States
Evangelische Krankenhaus Abteilung Kardiologie Kirchfeldstr. 40
🇩🇪Dusseldorf, Germany
Regional Cardiology Associates
🇺🇸Sacramento, California, United States
Wake Forest School of Medicine
🇺🇸Winston-Salem, North Carolina, United States
Maine Cardiology Assoc.
🇺🇸Portland, Maine, United States
Univ. Miami Jackson Mem. med. Ctr.
🇺🇸MIami, Florida, United States
Memorial Health Systems/Cardiology Research Associates
🇺🇸ORmond Beach, Florida, United States
Lahey Hitchcock Medical Ctr.
🇺🇸Burlington, Massachusetts, United States
Atlantic Health Systems
🇺🇸Passaic, New Jersey, United States
Huntington Hospital
🇺🇸Huntington, New York, United States
University of Rochester Strong mem. Hospital
🇺🇸Rochester, New York, United States
Mid Carolina Cardiology
🇺🇸Charlotte, North Carolina, United States
CHRU de Nancy-29 av. de Lattre de Tassigny
🇫🇷Nancy, France
United HealthNetwork/Ohio Heart Center
🇺🇸Canton, Ohio, United States
Lancaster Heart Foundation
🇺🇸Lancaster, Pennsylvania, United States
Doylestown Medical Hospital
🇺🇸Doylestown, Pennsylvania, United States
Medical College of Ohio
🇺🇸Toledo, Ohio, United States
Inland Cardiology/The Heart Inst.
🇺🇸Spokane, Washington, United States
Medical College of VA
🇺🇸RIchmond, Virginia, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Academisch ZiekenhuisRotterdam, Thoraxentrum Dr. Molewaterplein 40
🇨🇦Rotterdam, Newfoundland and Labrador, Canada
Cardiology Associates of Green Bay
🇺🇸Green Bay, Wisconsin, United States
The Cardiovascular Grp./Attn: Mandy Murphy
🇺🇸Fairfax, Virginia, United States
CHRU de Nantes-Hopital G. et R. Laennec-bd Jacques Monod
🇫🇷Nantes, France
CHRU de Rennes-Hotel Dieu-2 rue l'hotel Dieu
🇫🇷Rennes, France
Klinikum der Johann-Wolfgang-Goethe-Universitat Medizinische Klinik IV Abteilung Elektrophysiologie Theodor-Stern-Kai 7
🇩🇪Frankfurt, Germany
Medizinische Universitatsklinik
🇩🇪Freiburg, Germany
Stadtisches Klinikum Brandenburg Medizinische Klinik I Kardiologie Hochstr. 29
🇩🇪Branderburg an der Havel, Germany
Universitatsklinikum Dusseldorf Klinik fur Kardiologie Moorenstr. 5
🇩🇪Dusseldorf, Germany
Klinikum der Stadt Ludwigshafen Bremserstr. 79
🇩🇪Ludwigshafen, Germany
Medizinische Universitats Klinik Heidelberg Medisin III (Kardiologie) Bergheimerstr. 58
🇩🇪Heidelberg, Germany
Stadt. Klinikum Nurnberg-Sud Med. Klinik 8-Kardiologie Kardiologie KH II/8
🇩🇪Nurnberg, 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
Ospedale Maggiore della carita II Divisione di cardiologia, corso mazzini 18
🇮🇹Novara, Italy
Istituto di Malattie cardiovasolari policlinico di bari piazza G Cesare 11
🇮🇹Bari, Italy
Medizinische Klinik und Poliklinik Universitat Tubingen Ottfried-Muller-Str. 10
🇩🇪Tubingen, Germany
Klinikum Wuppwrtal GmbH Klinik Fur Herz-und Thoraxchirugie Arrenbergerstr. 20
🇩🇪Wuppertal, Germany
Policlinico Matteo Dippartimento di cardiologia Pizza Golgi, 2
🇮🇹Pavia, Italy
Divisione di cardiologia Ospedale s. Flippo Neri, Via Martinotti 20
🇮🇹Roma, Italy
Academisch Medisch Centrum Amsterdam Afd. Cardiologie Meibergdreef 9
🇳🇱Amsterdam, Netherlands
Catharina Ziekenhuis Afd. Cardiologie Postbus 1350
🇳🇱Eldhoven, Netherlands
SintAntonius Ziekenhuis Afd R&D Cardiologie Koekoekslaan 1
🇳🇱Nieuwegein, Netherlands
Academisch Ziekenhuis Groningen Thoraxcentrum Hanzeplein 1
🇳🇱Groningen, Netherlands
Leids Universitair Medisch Centrum Afd. Cardiologie Postbus 9600
🇳🇱Leiden, Netherlands
1 Klinka kardiologii Slaska Akademia Medyczna, Ziolowa 47
🇵🇱Katowice, Poland
ll Klinika Chorob Serca Akademii Medycznej w Gdansku Kieturakisa 1
🇵🇱Gdansk, Poland
Oddzial kardiologii-Instut kardiologii, Ul Powstancow
🇵🇱Szczecin, Poland
Instytut Kardiologii-Klinka Kardiologii Ogolnej, ul. Alpejska 42
🇵🇱Warszawa, Poland
Instytut Kardiologii Klinika Choroby Wiencowej,ul Spartanka 1
🇵🇱Warszawa, Poland
Hospital Clinic i Provincial, Servicio de Cardiologia, Villarroel, 170
🇪🇸Barcelona, Spain
Hospital Clinico Universitario de Valencia, Avenida Blasco Ibanez, 17
🇪🇸Valencia, Spain
Hospital Virgen de la Victoria, Campus Universitario de Teatinos, s/n
🇪🇸Malaga, Spain
Clinica Puerta de Hierro, San Martin de Porres, 4
🇪🇸Madrid, Spain
Florida Heart Institute
🇺🇸Orlando, Florida, United States
University Cardiology
🇺🇸Louisville, Kentucky, United States
Louisville Cardiology Medical Group, PSC
🇺🇸Louisville, Kentucky, United States
The Watson Clinic, LLP
🇺🇸Lakeland, Florida, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States