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Efficacy and Safety Evaluation of Azimilide Dihydrochloride in Patients with Implantable Cardioverter Defibrillators Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Efficacy and Safety Evaluation of Azimilide Dihydrochloride in Patients with Implantable Cardioverter Defibrillators conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Efficacy and Safety Evaluation of Azimilide Dihydrochloride in Patients with Implantable Cardioverter Defibrillators Clinical research trials and Efficacy and Safety Evaluation of Azimilide Dihydrochloride in Patients with Implantable Cardioverter Defibrillators healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Efficacy and Safety Evaluation of Azimilide Dihydrochloride in Patients with Implantable Cardioverter Defibrillators. Efficacy and Safety Evaluation of Azimilide Dihydrochloride in Patients with Implantable Cardioverter Defibrillators Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Efficacy and Safety Evaluation of Azimilide Dihydrochloride in Patients with Implantable Cardioverter Defibrillators clinical trial. Human subjects often receive the most effective healthcare possible for their Efficacy and Safety Evaluation of Azimilide Dihydrochloride in Patients with Implantable Cardioverter Defibrillators condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "E" Clinical Trials Conditions > Efficacy and Safety Evaluation of Azimilide Dihydrochloride in Patients with Implantable Cardioverter Defibrillators  Efficacy and Safety Evaluation of Azimilide Dihydrochloride in Patients with Implantable Cardioverter Defibrillators
Efficacy and Safety Evaluation of Azimilide Dihydrochloride in Patients with Implantable Cardioverter Defibrillators
For Condition: Arrhythmia
Status: Completed
Sponsor(s): Procter & Gamble Pharmaceuticals ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 624
Location and Contact Information:
Policlinico Matteo Dippartimento di cardiologia Pizza Golgi, 2
Pavia, , 27100
Italy
Stadtisches Klinikum Brandenburg Medizinische Klinik I Kardiologie Hochstr. 29
Branderburg an der Havel, , 14770
Germany
CHRU de Nancy-29 av. de Lattre de Tassigny
Nancy, , CEDEX 54 035
France
Istituto di Malattie cardiovasolari policlinico di bari piazza G Cesare 11
Bari, , 70120
Italy
Hospital Virgen de la Victoria, Campus Universitario de Teatinos, s/n
Malaga, , 29010
Spain
University of Rochester Strong mem. Hospital
Rochester, New York, 14642
United States
University of Utah Medical Ctr.
Salt Lake City, Utah, 84132
United States
Good Samaritan Hospital
Los Angeles, California, 90017
United States
Brookdale University Hospital
Brooklyn, New York, 111212
United States
Jacksonville Heart Center
Jacksonville, Florida, 32250
United States
Univ of PA/Presbyterian Hospital
Philadelphia, Pennsylvania, 19104
United States
Heart Place/Baylor University of Medicine
Dallas, Texas, 75246
United States
Doylestown Medical Hospital
Doylestown, Pennsylvania, 18901
United States
Herz-kreislauf-Klinik Bevensen AG Kardiologie Akut Romstedter Str. 25
Bad Bevensen, , 29549
Germany
Lancaster Heart Foundation
Lancaster, Pennsylvania, 17603
United States
Loyola University Med. Ctr.
Maywood, Illinois, 60153
United States
Hopital Nord-Chemin Bourrely St Antoine
Marseille, , CEDEX 20 13915
France
St. Lukes/Roosevelt Hospital Center
New York City, New York, 10025
United States
CHRU de Rennes-Hotel Dieu-2 rue l'hotel Dieu
Rennes, , CEDEX 35 033
France
Cardiac Arrythmia Trials/Royal Jubilee Hosp.
Victoria, British Columbia, V8R-4R2
Canada
Academisch ZiekenhuisRotterdam, Thoraxentrum Dr. Molewaterplein 40
Rotterdam, Newfoundland and Labrador, 3015 GD
Canada
Universitats-Krankenhaus Eppendorf Abteilung Kardiologie Martinistr. 52
Hamburg, , 20246
Germany
Cardiac Arrythmia Associates
San Diego, California, 92037
United States
U. OF Virginia/Dept of Cardiology
Charlottesville, Virginia, 22908
United States
UCSD Medical Center
San Diego, California, 92103
United States
The Watson Clinic, LLP
Lakeland, Florida, 33805
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
Clin. Univ. UCL de Mont-Godinne-
Yvoir, , 5530
Belgium
Maine Cardiology Assoc.
Portland, Maine, 04102
United States
Oddzial kardiologii-Instut kardiologii, Ul Powstancow
Szczecin, , 70111
Poland
Florida Arrythmia Consultants
Ft. Lauderdale, Florida, 33308
United States
St Elizabeth Medical Center
Boston, Massachusetts, 02135
United States
Florida Heart Institute
Orlando, Florida, 32803
United States
Oklahoma Heart Institute
Tulsa, Oklahoma, 74104
United States
Universitatsklinikum Dusseldorf Klinik fur Kardiologie Moorenstr. 5
Dusseldorf, , 40225
Germany
Huntington Hospital
Huntington, New York, 11743
United States
Loma Linda Univ. Med. Ctr.
Loma Linda, California, 92354
United States
The Lindnar Clinical Trial Center
Cincinnati, Ohio, 45219
United States
Virchow-Klinikum Franz-Volhard-Klinik Wiltbergstr. 50
Berlin, , 13125
Germany
Medizinische Universitatsklinik
Freiburg, , 79106
Germany
Barry Alpert, MD, FACC
Pittsburgh, Pennsylvania, 15224
United States
Medizinische Universitatsklinik Leipzigerstr. 44
Magdeburg, , 39120
Germany
Louisville Cardiology Medical Group, PSC
Louisville, Kentucky, 40207
United States
Instytut Kardiologii-Klinka Kardiologii Ogolnej, ul. Alpejska 42
Warszawa, , 04628
Poland
Inland Cardiology/The Heart Inst.
Spokane, Washington, 99204
United States
Hershey Med. Ctr.-Div. Cardiology
Hershey, Pennsylvania, 17033
United States
Hospital 12 de Octubre, Carretera de Andalucia, km. 5, 4
Madrid, , 28041
Spain
Bridgeport Hospital
Bridgeport, Connecticut, 06610
United States
Isala Klinieken Loc Weezenlanden Afd. Cardiologie Groot Wezenland 20
Zwolle, Newfoundland and Labrador, 8011JW
Canada
LSU Health Sciences Center
Shreveport, Louisiana, 71130
United States
University of Mass. Medical Ctr. Division of Cardiovascular Medicine
Worcester, Massachusetts, 01655
United States
Mid-America Cardiology c/o KU medical Ctr
Kansas City, Kansas, 66160
United States
Univ. Miami Jackson Mem. med. Ctr.
Miami, Florida, 33136
United States
Memorial Hospital
Colorado Springs, Colorado, 80910
United States
Klinikum Grobhadern Universitat Munchen Marchioninistr. 15
Munchen, , 81377
Germany
The Cardiovascular Grp./Attn: Mandy Murphy
Fairfax, Virginia, 22031
United States
Charite Campus Buch Franz-Vollhard-Klinik Wiltbergstr. 50
Berlin, , 13125
Germany
Medical College of Ohio
Toledo, Ohio, 43614
United States
Morristown Memorial Hospital
Morristown, New Jersey, 07962
United States
Stadt. Klinikum Nurnberg-Sud Med. Klinik 8-Kardiologie Kardiologie KH II/8
Nurnberg, , 90471
Germany
UT Southwestern Medical Center at Dallas
Dallas, Texas, 75390-9047
United States
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
Canada
Clinica Puerta de Hierro, San Martin de Porres, 4
Madrid, , 28035
Spain
Medical College of VA
Richmond, Virginia, 23219
United States
Hopital cardiologique du Haut Leveque-av. de Magellan
Pessac, , CEDEX-33 604
France
Klinikum der Johann-Wolfgang-Goethe-Universitat Medizinische Klinik IV Abteilung Elektrophysiologie Theodor-Stern-Kai 7
Frankfurt, , M. 60590
Germany
United HealthNetwork/Ohio Heart Center
Canton, Ohio, 44718
United States
Cardiovascular Assoc.
Eugene, Oregon, 97401
United States
Centre hospitalier L. Pradel-28 av. du doyen Lepine
Lyon, , CEDEX 3-69 394
France
ll Klinika Chorob Serca Akademii Medycznej w Gdansku Kieturakisa 1
Gdansk, , 80742
Poland
Catharina Ziekenhuis Afd. Cardiologie Postbus 1350
Eldhoven, , 5602ZA
Netherlands
Klinikum Wuppwrtal GmbH Klinik Fur Herz-und Thoraxchirugie Arrenbergerstr. 20
Wuppertal, , 42117
Germany
Memorial Health Systems/Cardiology Research Associates
Ormond Beach, Florida, 32174
United States
Instytut Kardiologii Klinika Choroby Wiencowej,ul Spartanka 1
Warszawa, , 02637
Poland
Duke University Medical Ctr.
Durham, North Carolina, 27710
United States
Dayton Cardiac EP
Dayton, Ohio, 45406
United States
Hopital Lariboisiere-2 rue A. Pare
Paris, , CEDEX 75010
France
Health Sciences Ctr
St. Johns, Newfoundland and Labrador, A1B-3V6
Canada
Ospedale Maggiore della carita II Divisione di cardiologia, corso mazzini 18
Novara, , 28100
Italy
University of Alberta Hospital
Edmonton, Alberta, T6G-2B7
Canada
Wake Forest School of Medicine
Winston Salem, North Carolina, 27157
United States
Medizinische Klinik und Poliklinik Universitat Tubingen Ottfried-Muller-Str. 10
Tubingen, , 72076
Germany
UAMS Dept of Cardiology
Little Rock, Arkansas, 72205
United States
Mid-Atlantic Cardiovascular Associates
Baltimore, Maryland, 21204
United States
Evangelische Krankenhaus Abteilung Kardiologie Kirchfeldstr. 40
Dusseldorf, , 40217
Germany
ATC/Cardio Medical Grp
Beverly Hills, California, 90210
United States
Universitatsklinikum I. Medizinische Klinik Kardiologie/Angiologie/Pneumologie Theodor-Kutzer-Ufer 1-3
Mannheim, , 68135
Germany
Midwest Cardio Res. Foundation
Columbus, Ohio, 43214
United States
QE II Health Sciences Ctr.
Halifax, Nova Scotia, B3K-3A7
Canada
The Mt Sinai Medical Ctr.
New York City, New York, 10029
United States
Winnepeg Health Science Ctr.
Winnepeg, , R3E 0Z3
Canada
Academisch Medisch Centrum Amsterdam Afd. Cardiologie Meibergdreef 9
Amsterdam, , 1105AZ
Netherlands
SintAntonius Ziekenhuis Afd R&D Cardiologie Koekoekslaan 1
Nieuwegein, , 3435CM
Netherlands
Southwest Florida Health Group
Ft. Myers, Florida, 33919
United States
University Cardiology
Louisville, Kentucky, 40202
United States
Divisione di cardiologia Ospedale s. Flippo Neri, Via Martinotti 20
Roma, , 168
Italy
SMDC Education Research
Duluth, Minnesota, 55805
United States
Rochester Cardiopulmonary Group
Rochester, New York, 14621
United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
United States
1 Klinka kardiologii Slaska Akademia Medyczna, Ziolowa 47
Katowice, , 40 635
Poland
VA Greater Los Angeles Healthcare System
Los Angeles, California, 90073
United States
Hamilton General Hospital/McMaster Clinic
Hamilton, Ontario, L8L-2X2
Canada
Universitatsklinikum Bonn Medizinische Klinik und Poliklinik II Sigmund-Freud-Str. 25
Bonn, , 53105
Germany
Krankenhaus Am Urban Innere Medizin I (Kardiologie) Dieffenbachstr. 1
Berlin, , 10967
Germany
Arrhythmia and Pacemaker Consultants
West Orange, New Jersey, 07052
United States
Deutsches Herzzentrum Minchen Lazarettstr. 36
Munchen, , 80636
Germany
Laval Hospital
Ste Foy, Quebec, G1V-4G5
Canada
CHRU de Lille-Hopital Cardiologique-Bd du Pr Leclerc
Lille, , CEDEX 59 037-
France
Leids Universitair Medisch Centrum Afd. Cardiologie Postbus 9600
Leiden, , 2300 RC
Netherlands
Hospital Clinic i Provincial, Servicio de Cardiologia, Villarroel, 170
Barcelona, , 8036
Spain
Buffalo Cardiology & Pulmonary Assoc.
Williamsville, New York, 14221
United States
Nevada Cardiology
Las Vegas, Nevada, 89109
United States
University Hospitals of Cleveland
Cleveland, Ohio, 44106
United States
Blackstone Cardiology Assoc. P.C.
Pawtucket, Rhode Island, 02860
United States
CHRU de TOURS-Hopital TROUSSEAU-Chanbray les Tours
Tours, , CEDEX-37044
France
Baystate Medical Center-Cardiology Research
Springfield, Massachusetts, 01199
United States
South Carolina Heart Center
Columbia, South Carolina, 29204
United States
Lahey Hitchcock Medical Ctr.
Burlington, Massachusetts, 01805
United States
Tri-City Cardiology Consultants, P.C.
Mesa, Arizona, 85206
United States
Kerckhoff Klinik Abteilung Elektrophysiologie Benekestr. 2
Bad Nauheim, , 61230
Germany
Klinikum Coburg Ketschendorferstr. 33
Coburg, , 96450
Germany
CHRU de Nantes-Hopital G. et R. Laennec-bd Jacques Monod
Nantes, , CEDEX 44 093
France
Cardiology Associates of Green Bay
Green Bay, Wisconsin, 54301
United States
University of Minnesota-Cardiology
Minneapolis, Minnesota, 55455
United States
Atlantic Health Systems
Passaic, New Jersey, 07055
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
Wisconsin Ctr for Clinical Research
Milwaukee, Wisconsin, 53215
United States
Cardiology Assoc., PC
Johnson City, New York, 13797
United States
Mid Carolina Cardiology
Charlotte, North Carolina, 28204
United States
Mid-State Cardiology
Nashville, Tennessee, 37203
United States
Klinikum der Stadt Ludwigshafen Bremserstr. 79
Ludwigshafen, , 67063
Germany
Academisch Ziekenhuis Groningen Thoraxcentrum Hanzeplein 1
Groningen, , 9713GZ
Netherlands
University of Iowa Hospital
Iowa City, Iowa, 52242
United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010
United States
St Michaels Hospital 30 Bond Street 7-050 Queen
Toronto, Ontario, M5B-1W8
Canada
Medizinische Universitats Klinik Heidelberg Medisin III (Kardiologie) Bergheimerstr. 58
Heidelberg, , 69115
Germany
A.Z. Sint-Jan, Ruddershove, 10
Brugge, , 8000
Belgium
Hospital Clinico Universitario de Valencia, Avenida Blasco Ibanez, 17
Valencia, , 46010
Spain
Regional Cardiology Associates
Sacramento, California, 95819
United States
Herzzentrum NRW Kardiologische Ambulanz Georgstr. 11
Bad Oeynhausen, , 32545
Germany
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
The Heart Group
Mobile, Alabama, 36608
United States
Additional Information:
Study ID Numbers: 2000098;
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00035490
Other Arrhythmia Studies:
1. Anxiety and Vagal Control of the Heart in Coronary Disease
2. Antiarrhythmic Effects of N-3 Fatty Acids
3. Multicenter Study of Silent Myocardial Ischemia (MSSMI)
4. Technology Dependency and Health-Related Quality of Life
5. Cardiac Arrhythmia Pilot Study (CAPS)
Related Studies:
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Efficacy and Safety Evaluation of Azimilide Dihydrochloride in Patients with Implantable Cardioverter Defibrillators
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