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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00035490
Other study ID # 2000098
Secondary ID
Status Completed
Phase Phase 3
First received May 3, 2002
Last updated September 30, 2011
Start date September 2001
Est. completion date April 2004

Study information

Verified date September 2011
Source Forest Laboratories
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 633
Est. completion date April 2004
Est. primary completion date April 2004
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
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

Locations

Country Name City State
Belgium A.Z. Sint-Jan, Ruddershove, 10 Brugge
Belgium Clin. Univ. UCL de Mont-Godinne- Yvoir
Canada University of Alberta Hospital Edmonton Alberta
Canada QE II Health Sciences Ctr. Halifax Nova Scotia
Canada Hamilton General Hospital/McMaster Clinic Hamilton Ontario
Canada Montreal Heart Institute Montreal Quebec
Canada Academisch ZiekenhuisRotterdam, Thoraxentrum Dr. Molewaterplein 40 Rotterdam Newfoundland and Labrador
Canada Health Sciences Ctr St Johns Newfoundland and Labrador
Canada Laval Hospital Ste-Foy Quebec
Canada St Michaels Hospital 30 Bond Street 7-050 Queen Toronto Ontario
Canada Cardiac Arrythmia Trials/Royal Jubilee Hosp. Victoria British Columbia
Canada Winnepeg Health Science Ctr. Winnepeg
Canada Isala Klinieken Loc Weezenlanden Afd. Cardiologie Groot Wezenland 20 Zwolle Newfoundland and Labrador
France 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
Germany 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 Charite Campus Buch Franz-Vollhard-Klinik Wiltbergstr. 50 Berlin
Germany Krankenhaus Am Urban Innere Medizin I (Kardiologie) Dieffenbachstr. 1 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 Dusseldorf
Germany Universitatsklinikum Dusseldorf Klinik fur Kardiologie Moorenstr. 5 Dusseldorf
Germany Klinikum der Johann-Wolfgang-Goethe-Universitat Medizinische Klinik IV Abteilung Elektrophysiologie Theodor-Stern-Kai 7 Frankfurt
Germany Medizinische Universitatsklinik Freiburg
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 Munchen
Germany Klinikum Grobhadern Universitat Munchen Marchioninistr. 15 Munchen
Germany Stadt. Klinikum Nurnberg-Sud Med. Klinik 8-Kardiologie Kardiologie KH II/8 Nurnberg
Germany Medizinische Klinik und Poliklinik Universitat Tubingen Ottfried-Muller-Str. 10 Tubingen
Germany Klinikum Wuppwrtal GmbH Klinik Fur Herz-und Thoraxchirugie Arrenbergerstr. 20 Wuppertal
Italy 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
Netherlands 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
Poland 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 Warszawa
Poland Instytut Kardiologii-Klinka Kardiologii Ogolnej, ul. Alpejska 42 Warszawa
Spain 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 Malaga
Spain Hospital Clinico Universitario de Valencia, Avenida Blasco Ibanez, 17 Valencia
United States Mid-Atlantic Cardiovascular Associates Baltimore Maryland
United States ATC/Cardio Medical Grp Beverly Hills California
United States St Elizabeth Medical Center Boston Massachusetts
United States Bridgeport Hospital Bridgeport Connecticut
United States Brookdale University Hospital Brooklyn New York
United States Lahey Hitchcock Medical Ctr. Burlington Massachusetts
United States United HealthNetwork/Ohio Heart Center Canton Ohio
United States Medical University of South Carolina Charleston South Carolina
United States Mid Carolina Cardiology Charlotte North Carolina
United States U. OF Virginia/Dept of Cardiology Charlottesville Virginia
United States The Lindnar Clinical Trial Center Cincinnati Ohio
United States Cleveland Clinic Foundation Cleveland Ohio
United States University Hospitals of Cleveland Cleveland Ohio
United States Memorial Hospital Colorado Springs Colorado
United States South Carolina Heart Center Columbia South Carolina
United States Midwest Cardio Res. Foundation Columbus Ohio
United States Heart Place/Baylor University of Medicine Dallas Texas
United States UT Southwestern Medical Center at Dallas Dallas Texas
United States Dayton Cardiac EP Dayton Ohio
United States Doylestown Medical Hospital Doylestown Pennsylvania
United States SMDC Education Research Duluth Minnesota
United States Duke University Medical Ctr. Durham North Carolina
United States Cardiovascular Assoc. Eugene Oregon
United States The Cardiovascular Grp./Attn: Mandy Murphy Fairfax Virginia
United States Southwest Florida Health Group Fort Myers Florida
United States Florida Arrythmia Consultants Ft Lauderdale Florida
United States Cardiology Associates of Green Bay Green Bay Wisconsin
United States Hershey Med. Ctr.-Div. Cardiology Hershey Pennsylvania
United States Baylor College of Medicine Houston Texas
United States Huntington Hospital Huntington New York
United States University of Iowa Hospital Iowa City Iowa
United States Jacksonville Heart Center Jacksonville Florida
United States Cardiology Assoc., PC Johnson City New York
United States Mid-America Cardiology c/o KU medical Ctr Kansas City Kansas
United States The Watson Clinic, LLP Lakeland Florida
United States Lancaster Heart Foundation Lancaster Pennsylvania
United States Nevada Cardiology Las Vegas Nevada
United States UAMS Dept of Cardiology Little Rock Arkansas
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 Louisville Cardiology Medical Group, PSC Louisville Kentucky
United States University Cardiology Louisville Kentucky
United States Loyola University Med. Ctr. Maywood Illinois
United States Tri-City Cardiology Consultants, P.C. Mesa Arizona
United States Univ. Miami Jackson Mem. med. Ctr. MIami Florida
United States Wisconsin Ctr for Clinical Research Milwaukee Wisconsin
United States University of Minnesota-Cardiology Minneapolis Minnesota
United States The Heart Group Mobile Alabama
United States Morristown Memorial Hospital Morristown New Jersey
United States Mid-State Cardiology Nashville Tennessee
United States St. Lukes/Roosevelt Hospital Center New York New York
United States The Mt Sinai Medical Ctr. New York New York
United States Florida Heart Institute Orlando Florida
United States Memorial Health Systems/Cardiology Research Associates ORmond Beach Florida
United States Atlantic Health Systems Passaic New Jersey
United States Blackstone Cardiology Assoc. P.C. Pawtucket Rhode Island
United States Thomas Jefferson University Philadelphia Pennsylvania
United States Univ of PA/Presbyterian Hospital Philadelphia Pennsylvania
United States Barry Alpert, MD, FACC Pittsburgh Pennsylvania
United States Maine Cardiology Assoc. Portland Maine
United States Medical College of VA RIchmond Virginia
United States Rochester Cardiopulmonary Group Rochester New York
United States University of Rochester Strong mem. Hospital Rochester New York
United States Regional Cardiology Associates Sacramento California
United States University of Utah Medical Ctr. Salt Lake CIty Utah
United States Cardiac Arrythmia Associates San Diego California
United States UCSD Medical Center San Diego California
United States LSU Health Sciences Center Shreveport Louisiana
United States Inland Cardiology/The Heart Inst. Spokane Washington
United States Baystate Medical Center-Cardiology Research Springfield Massachusetts
United States Medical College of Ohio Toledo Ohio
United States Oklahoma Heart Institute Tulsa Oklahoma
United States Washington Hospital Center Washington District of Columbia
United States Arrhythmia and Pacemaker Consultants West Orange New Jersey
United States Buffalo Cardiology & Pulmonary Assoc. Williamsville New York
United States Wake Forest School of Medicine Winston-Salem North Carolina
United States University of Mass. Medical Ctr. Division of Cardiovascular Medicine Worcester Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Forest Laboratories

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  France,  Germany,  Italy,  Netherlands,  Poland,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reducing the recurrence of all-cause shocks plus symptomatic ATP one year No
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