Efficacy and Safety Evaluation of Azimilide Dihydrochloride in Patients With Implantable Cardioverter Defibrillators
NCT ID: NCT00035490
Last Updated: 2011-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
633 participants
INTERVENTIONAL
2001-09-30
2004-04-30
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Placebo tablets
placebo
placebo tablet, once daily for one year
2
75 mg azimilide
Azimilide Dihydrochloride
75 mg azimilide, once a day for one year
3
125 mg azimilide
Azimilide Dihydrochloride
125 mg azimilide, once a day for one year
Interventions
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Azimilide Dihydrochloride
125 mg azimilide, once a day for one year
placebo
placebo tablet, once daily for one year
Azimilide Dihydrochloride
75 mg azimilide, once a day for one year
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Forest Laboratories
INDUSTRY
Responsible Party
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Procter & Gamble Pharmaceuticals
Principal Investigators
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Jose M Brum, MD
Role: STUDY_DIRECTOR
Procter and Gamble
Locations
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The Heart Group
Mobile, Alabama, United States
Tri-City Cardiology Consultants, P.C.
Mesa, Arizona, United States
UAMS Dept of Cardiology
Little Rock, Arkansas, United States
ATC/Cardio Medical Grp
Beverly Hills, California, 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
Regional Cardiology Associates
Sacramento, California, United States
Cardiac Arrythmia Associates
San Diego, California, United States
UCSD Medical Center
San Diego, California, United States
Memorial Hospital
Colorado Springs, Colorado, United States
Bridgeport Hospital
Bridgeport, Connecticut, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Florida Arrythmia Consultants
Fort Lauderdale, Florida, United States
Southwest Florida Health Group
Fort Myers, Florida, United States
Jacksonville Heart Center
Jacksonville, Florida, United States
The Watson Clinic, LLP
Lakeland, Florida, United States
Univ. Miami Jackson Mem. med. Ctr.
Miami, Florida, United States
Florida Heart Institute
Orlando, Florida, United States
Memorial Health Systems/Cardiology Research Associates
Ormond Beach, Florida, United States
Loyola University Med. Ctr.
Maywood, Illinois, United States
University of Iowa Hospital
Iowa City, Iowa, United States
Mid-America Cardiology c/o KU medical Ctr
Kansas City, Kansas, United States
University Cardiology
Louisville, Kentucky, United States
Louisville Cardiology Medical Group, PSC
Louisville, Kentucky, United States
LSU Health Sciences Center
Shreveport, Louisiana, United States
Maine Cardiology Assoc.
Portland, Maine, United States
Mid-Atlantic Cardiovascular Associates
Baltimore, Maryland, United States
St Elizabeth Medical Center
Boston, Massachusetts, United States
Lahey Hitchcock Medical Ctr.
Burlington, Massachusetts, United States
Baystate Medical Center-Cardiology Research
Springfield, Massachusetts, United States
University of Mass. Medical Ctr. Division of Cardiovascular Medicine
Worcester, Massachusetts, United States
SMDC Education Research
Duluth, Minnesota, United States
University of Minnesota-Cardiology
Minneapolis, Minnesota, United States
Nevada Cardiology
Las Vegas, Nevada, United States
Morristown Memorial Hospital
Morristown, New Jersey, United States
Atlantic Health Systems
Passaic, New Jersey, United States
Arrhythmia and Pacemaker Consultants
West Orange, New Jersey, United States
Brookdale University Hospital
Brooklyn, New York, United States
Huntington Hospital
Huntington, New York, United States
Cardiology Assoc., PC
Johnson City, New York, United States
St. Lukes/Roosevelt Hospital Center
New York, New York, United States
The Mt Sinai Medical Ctr.
New York, New York, United States
Rochester Cardiopulmonary Group
Rochester, New York, United States
University of Rochester Strong mem. Hospital
Rochester, New York, United States
Buffalo Cardiology & Pulmonary Assoc.
Williamsville, New York, United States
Mid Carolina Cardiology
Charlotte, North Carolina, United States
Duke University Medical Ctr.
Durham, North Carolina, United States
Wake Forest School of Medicine
Winston-Salem, North Carolina, United States
United HealthNetwork/Ohio Heart Center
Canton, Ohio, United States
The Lindnar Clinical Trial Center
Cincinnati, Ohio, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Midwest Cardio Res. Foundation
Columbus, Ohio, United States
Dayton Cardiac EP
Dayton, Ohio, United States
Medical College of Ohio
Toledo, Ohio, United States
Oklahoma Heart Institute
Tulsa, Oklahoma, United States
Cardiovascular Assoc.
Eugene, Oregon, United States
Doylestown Medical Hospital
Doylestown, Pennsylvania, United States
Hershey Med. Ctr.-Div. Cardiology
Hershey, Pennsylvania, United States
Lancaster Heart Foundation
Lancaster, Pennsylvania, United States
Univ of PA/Presbyterian Hospital
Philadelphia, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Barry Alpert, MD, FACC
Pittsburgh, Pennsylvania, United States
Blackstone Cardiology Assoc. P.C.
Pawtucket, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
South Carolina Heart Center
Columbia, South Carolina, United States
Mid-State Cardiology
Nashville, Tennessee, United States
Heart Place/Baylor University of Medicine
Dallas, Texas, United States
UT Southwestern Medical Center at Dallas
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
University of Utah Medical Ctr.
Salt Lake City, Utah, United States
U. OF Virginia/Dept of Cardiology
Charlottesville, Virginia, United States
The Cardiovascular Grp./Attn: Mandy Murphy
Fairfax, Virginia, United States
Medical College of VA
Richmond, Virginia, United States
Inland Cardiology/The Heart Inst.
Spokane, Washington, United States
Cardiology Associates of Green Bay
Green Bay, Wisconsin, United States
Wisconsin Ctr for Clinical Research
Milwaukee, Wisconsin, United States
A.Z. Sint-Jan, Ruddershove, 10
Bruges, , Belgium
Clin. Univ. UCL de Mont-Godinne-
Yvoir, , Belgium
University of Alberta Hospital
Edmonton, Alberta, Canada
Cardiac Arrythmia Trials/Royal Jubilee Hosp.
Victoria, British Columbia, Canada
Academisch ZiekenhuisRotterdam, Thoraxentrum Dr. Molewaterplein 40
Rotterdam, Newfoundland and Labrador, Canada
Health Sciences Ctr
St. John's, Newfoundland and Labrador, Canada
Isala Klinieken Loc Weezenlanden Afd. Cardiologie Groot Wezenland 20
Zwolle, Newfoundland and Labrador, Canada
QE II Health Sciences Ctr.
Halifax, Nova Scotia, Canada
Hamilton General Hospital/McMaster Clinic
Hamilton, Ontario, Canada
St Michaels Hospital 30 Bond Street 7-050 Queen
Toronto, Ontario, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
Laval Hospital
Ste-Foy, Quebec, Canada
Winnepeg Health Science Ctr.
Winnepeg, , Canada
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, , France
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
Krankenhaus Am Urban Innere Medizin I (Kardiologie) Dieffenbachstr. 1
Berlin, , Germany
Charite Campus Buch Franz-Vollhard-Klinik Wiltbergstr. 50
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
Düsseldorf, , Germany
Universitatsklinikum Dusseldorf Klinik fur Kardiologie Moorenstr. 5
Düsseldorf, , Germany
Klinikum der Johann-Wolfgang-Goethe-Universitat Medizinische Klinik IV Abteilung Elektrophysiologie Theodor-Stern-Kai 7
Frankfurt, , Germany
Medizinische Universitatsklinik
Freiburg im Breisgau, , 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
München, , Germany
Klinikum Grobhadern Universitat Munchen Marchioninistr. 15
München, , Germany
Stadt. Klinikum Nurnberg-Sud Med. Klinik 8-Kardiologie Kardiologie KH II/8
Nuremberg, , Germany
Medizinische Klinik und Poliklinik Universitat Tubingen Ottfried-Muller-Str. 10
Tübingen, , Germany
Klinikum Wuppwrtal GmbH Klinik Fur Herz-und Thoraxchirugie Arrenbergerstr. 20
Wuppertal, , Germany
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, , Italy
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, , Netherlands
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
Warsaw, , Poland
Instytut Kardiologii-Klinka Kardiologii Ogolnej, ul. Alpejska 42
Warsaw, , Poland
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
Málaga, , Spain
Hospital Clinico Universitario de Valencia, Avenida Blasco Ibanez, 17
Valencia, , Spain
Countries
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Other Identifiers
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2000098
Identifier Type: -
Identifier Source: org_study_id