Efficacy and Safety Evaluation of Azimilide Dihydrochloride in Patients With Implantable Cardioverter Defibrillators
Arrhythmia
About this trial
This is an interventional treatment trial for Arrhythmia
Eligibility 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
Sites / Locations
- The Heart Group
- Tri-City Cardiology Consultants, P.C.
- UAMS Dept of Cardiology
- ATC/Cardio Medical Grp
- Loma Linda Univ. Med. Ctr.
- Good Samaritan Hospital
- VA Greater Los Angeles Healthcare System
- Regional Cardiology Associates
- Cardiac Arrythmia Associates
- UCSD Medical Center
- Memorial Hospital
- Bridgeport Hospital
- Washington Hospital Center
- Southwest Florida Health Group
- Florida Arrythmia Consultants
- Jacksonville Heart Center
- The Watson Clinic, LLP
- Univ. Miami Jackson Mem. med. Ctr.
- Florida Heart Institute
- Memorial Health Systems/Cardiology Research Associates
- Loyola University Med. Ctr.
- University of Iowa Hospital
- Mid-America Cardiology c/o KU medical Ctr
- University Cardiology
- Louisville Cardiology Medical Group, PSC
- LSU Health Sciences Center
- Maine Cardiology Assoc.
- Mid-Atlantic Cardiovascular Associates
- St Elizabeth Medical Center
- Lahey Hitchcock Medical Ctr.
- Baystate Medical Center-Cardiology Research
- University of Mass. Medical Ctr. Division of Cardiovascular Medicine
- SMDC Education Research
- University of Minnesota-Cardiology
- Nevada Cardiology
- Morristown Memorial Hospital
- Atlantic Health Systems
- Arrhythmia and Pacemaker Consultants
- Brookdale University Hospital
- Huntington Hospital
- Cardiology Assoc., PC
- St. Lukes/Roosevelt Hospital Center
- The Mt Sinai Medical Ctr.
- Rochester Cardiopulmonary Group
- University of Rochester Strong mem. Hospital
- Buffalo Cardiology & Pulmonary Assoc.
- Mid Carolina Cardiology
- Duke University Medical Ctr.
- Wake Forest School of Medicine
- United HealthNetwork/Ohio Heart Center
- The Lindnar Clinical Trial Center
- University Hospitals of Cleveland
- Cleveland Clinic Foundation
- Midwest Cardio Res. Foundation
- Dayton Cardiac EP
- Medical College of Ohio
- Oklahoma Heart Institute
- Cardiovascular Assoc.
- Doylestown Medical Hospital
- Hershey Med. Ctr.-Div. Cardiology
- Lancaster Heart Foundation
- Univ of PA/Presbyterian Hospital
- Thomas Jefferson University
- Barry Alpert, MD, FACC
- Blackstone Cardiology Assoc. P.C.
- Medical University of South Carolina
- South Carolina Heart Center
- Mid-State Cardiology
- Heart Place/Baylor University of Medicine
- UT Southwestern Medical Center at Dallas
- Baylor College of Medicine
- University of Utah Medical Ctr.
- U. OF Virginia/Dept of Cardiology
- The Cardiovascular Grp./Attn: Mandy Murphy
- Medical College of VA
- Inland Cardiology/The Heart Inst.
- Cardiology Associates of Green Bay
- Wisconsin Ctr for Clinical Research
- A.Z. Sint-Jan, Ruddershove, 10
- Clin. Univ. UCL de Mont-Godinne-
- University of Alberta Hospital
- Cardiac Arrythmia Trials/Royal Jubilee Hosp.
- Academisch ZiekenhuisRotterdam, Thoraxentrum Dr. Molewaterplein 40
- Health Sciences Ctr
- Isala Klinieken Loc Weezenlanden Afd. Cardiologie Groot Wezenland 20
- QE II Health Sciences Ctr.
- Hamilton General Hospital/McMaster Clinic
- St Michaels Hospital 30 Bond Street 7-050 Queen
- Montreal Heart Institute
- Laval Hospital
- Winnepeg Health Science Ctr.
- CHRU de Lille-Hopital Cardiologique-Bd du Pr Leclerc
- Centre hospitalier L. Pradel-28 av. du doyen Lepine
- Hopital Nord-Chemin Bourrely St Antoine
- CHRU de Nancy-29 av. de Lattre de Tassigny
- CHRU de Nantes-Hopital G. et R. Laennec-bd Jacques Monod
- Hopital Lariboisiere-2 rue A. Pare
- Hopital cardiologique du Haut Leveque-av. de Magellan
- CHRU de Rennes-Hotel Dieu-2 rue l'hotel Dieu
- CHRU de TOURS-Hopital TROUSSEAU-Chanbray les Tours
- Herz-kreislauf-Klinik Bevensen AG Kardiologie Akut Romstedter Str. 25
- Kerckhoff Klinik Abteilung Elektrophysiologie Benekestr. 2
- Herzzentrum NRW Kardiologische Ambulanz Georgstr. 11
- Krankenhaus Am Urban Innere Medizin I (Kardiologie) Dieffenbachstr. 1
- Charite Campus Buch Franz-Vollhard-Klinik Wiltbergstr. 50
- Virchow-Klinikum Franz-Volhard-Klinik Wiltbergstr. 50
- Universitatsklinikum Bonn Medizinische Klinik und Poliklinik II Sigmund-Freud-Str. 25
- Stadtisches Klinikum Brandenburg Medizinische Klinik I Kardiologie Hochstr. 29
- Klinikum Coburg Ketschendorferstr. 33
- Evangelische Krankenhaus Abteilung Kardiologie Kirchfeldstr. 40
- Universitatsklinikum Dusseldorf Klinik fur Kardiologie Moorenstr. 5
- Klinikum der Johann-Wolfgang-Goethe-Universitat Medizinische Klinik IV Abteilung Elektrophysiologie Theodor-Stern-Kai 7
- Medizinische Universitatsklinik
- Universitats-Krankenhaus Eppendorf Abteilung Kardiologie Martinistr. 52
- Medizinische Universitats Klinik Heidelberg Medisin III (Kardiologie) Bergheimerstr. 58
- Klinikum der Stadt Ludwigshafen Bremserstr. 79
- Medizinische Universitatsklinik Leipzigerstr. 44
- Universitatsklinikum I. Medizinische Klinik Kardiologie/Angiologie/Pneumologie Theodor-Kutzer-Ufer 1-3
- Deutsches Herzzentrum Minchen Lazarettstr. 36
- Klinikum Grobhadern Universitat Munchen Marchioninistr. 15
- Stadt. Klinikum Nurnberg-Sud Med. Klinik 8-Kardiologie Kardiologie KH II/8
- Medizinische Klinik und Poliklinik Universitat Tubingen Ottfried-Muller-Str. 10
- Klinikum Wuppwrtal GmbH Klinik Fur Herz-und Thoraxchirugie Arrenbergerstr. 20
- Istituto di Malattie cardiovasolari policlinico di bari piazza G Cesare 11
- Ospedale Maggiore della carita II Divisione di cardiologia, corso mazzini 18
- Policlinico Matteo Dippartimento di cardiologia Pizza Golgi, 2
- Divisione di cardiologia Ospedale s. Flippo Neri, Via Martinotti 20
- Academisch Medisch Centrum Amsterdam Afd. Cardiologie Meibergdreef 9
- Catharina Ziekenhuis Afd. Cardiologie Postbus 1350
- Academisch Ziekenhuis Groningen Thoraxcentrum Hanzeplein 1
- Leids Universitair Medisch Centrum Afd. Cardiologie Postbus 9600
- SintAntonius Ziekenhuis Afd R&D Cardiologie Koekoekslaan 1
- ll Klinika Chorob Serca Akademii Medycznej w Gdansku Kieturakisa 1
- 1 Klinka kardiologii Slaska Akademia Medyczna, Ziolowa 47
- Oddzial kardiologii-Instut kardiologii, Ul Powstancow
- Instytut Kardiologii Klinika Choroby Wiencowej,ul Spartanka 1
- Instytut Kardiologii-Klinka Kardiologii Ogolnej, ul. Alpejska 42
- Hospital Clinic i Provincial, Servicio de Cardiologia, Villarroel, 170
- Clinica Puerta de Hierro, San Martin de Porres, 4
- Hospital 12 de Octubre, Carretera de Andalucia, km. 5, 4
- Hospital Virgen de la Victoria, Campus Universitario de Teatinos, s/n
- Hospital Clinico Universitario de Valencia, Avenida Blasco Ibanez, 17
Arms of the Study
Arm 1
Arm 2
Arm 3
Placebo Comparator
Experimental
Experimental
1
2
3
Placebo tablets
75 mg azimilide
125 mg azimilide