Clinical trial NCT00035490: Efficacy and Safety Evaluation of Azimilide Dihydrochloride in Patients With Implantable Cardioverter Defibrillators
Official title: Efficacy and Safety Evaluation of Azimilide Dihydrochloride in Patients With Implantable Cardioverter Defibrillators
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arrhythmia
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2002-05-06
Enrollment: 633
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Reducing the recurrence of all-cause shocks plus symptomatic ATP
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: The Heart Group
state: Alabama
city: Mesa
country: United States
facility: Tri-City Cardiology Consultants, P.C.
state: Arizona
city: Little Rock
country: United States
facility: UAMS Dept of Cardiology
state: Arkansas
city: Beverly Hills
country: United States
facility: ATC/Cardio Medical Grp
state: California
city: Loma Linda
country: United States
facility: Loma Linda Univ. Med. Ctr.
state: California
city: Los Angeles
country: United States
facility: Good Samaritan Hospital
state: California
city: Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System
state: California
city: Sacramento
country: United States
facility: Regional Cardiology Associates
state: California
city: San Diego
country: United States
facility: Cardiac Arrythmia Associates
state: California
city: San Diego
country: United States
facility: UCSD Medical Center
state: California
city: Colorado Springs
country: United States
facility: Memorial Hospital
state: Colorado
city: Bridgeport
country: United States
facility: Bridgeport Hospital
state: Connecticut
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Fort Myers
country: United States
facility: Southwest Florida Health Group
state: Florida
city: Ft Lauderdale
country: United States
facility: Florida Arrythmia Consultants
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Heart Center
state: Florida
city: Lakeland
country: United States
facility: The Watson Clinic, LLP
state: Florida
city: MIami
country: United States
facility: Univ. Miami Jackson Mem. med. Ctr.
state: Florida
city: Orlando
country: United States
facility: Florida Heart Institute
state: Florida
city: ORmond Beach
country: United States
facility: Memorial Health Systems/Cardiology Research Associates
state: Florida
city: Maywood
country: United States
facility: Loyola University Med. Ctr.
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospital
state: Iowa
city: Kansas City
country: United States
facility: Mid-America Cardiology c/o KU medical Ctr
state: Kansas
city: Louisville
country: United States
facility: University Cardiology
state: Kentucky
city: Louisville
country: United States
facility: Louisville Cardiology Medical Group, PSC
state: Kentucky
city: Shreveport
country: United States
facility: LSU Health Sciences Center
state: Louisiana
city: Portland
country: United States
facility: Maine Cardiology Assoc.
state: Maine
city: Baltimore
country: United States
facility: Mid-Atlantic Cardiovascular Associates
state: Maryland
city: Boston
country: United States
facility: St Elizabeth Medical Center
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Hitchcock Medical Ctr.
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Medical Center-Cardiology Research
state: Massachusetts
city: Worcester
country: United States
facility: University of Mass. Medical Ctr. Division of Cardiovascular Medicine
state: Massachusetts
city: Duluth
country: United States
facility: SMDC Education Research
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota-Cardiology
state: Minnesota
city: Las Vegas
country: United States
facility: Nevada Cardiology
state: Nevada
city: Morristown
country: United States
facility: Morristown Memorial Hospital
state: New Jersey
city: Passaic
country: United States
facility: Atlantic Health Systems
state: New Jersey
city: West Orange
country: United States
facility: Arrhythmia and Pacemaker Consultants
state: New Jersey
city: Brooklyn
country: United States
facility: Brookdale University Hospital
state: New York
city: Huntington
country: United States
facility: Huntington Hospital
state: New York
city: Johnson City
country: United States
facility: Cardiology Assoc., PC
state: New York
city: New York
country: United States
facility: St. Lukes/Roosevelt Hospital Center
state: New York
city: New York
country: United States
facility: The Mt Sinai Medical Ctr.
state: New York
city: Rochester
country: United States
facility: Rochester Cardiopulmonary Group
state: New York
city: Rochester
country: United States
facility: University of Rochester Strong mem. Hospital
state: New York
city: Williamsville
country: United States
facility: Buffalo Cardiology & Pulmonary Assoc.
state: New York
city: Charlotte
country: United States
facility: Mid Carolina Cardiology
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Ctr.
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest School of Medicine
state: North Carolina
city: Canton
country: United States
facility: United HealthNetwork/Ohio Heart Center
state: Ohio
city: Cincinnati
country: United States
facility: The Lindnar Clinical Trial Center
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Midwest Cardio Res. Foundation
state: Ohio
city: Dayton
country: United States
facility: Dayton Cardiac EP
state: Ohio
city: Toledo
country: United States
facility: Medical College of Ohio
state: Ohio
city: Tulsa
country: United States
facility: Oklahoma Heart Institute
state: Oklahoma
city: Eugene
country: United States
facility: Cardiovascular Assoc.
state: Oregon
city: Doylestown
country: United States
facility: Doylestown Medical Hospital
state: Pennsylvania
city: Hershey
country: United States
facility: Hershey Med. Ctr.-Div. Cardiology
state: Pennsylvania
city: Lancaster
country: United States
facility: Lancaster Heart Foundation
state: Pennsylvania
city: Philadelphia
country: United States
facility: Univ of PA/Presbyterian Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Barry Alpert, MD, FACC
state: Pennsylvania
city: Pawtucket
country: United States
facility: Blackstone Cardiology Assoc. P.C.
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Columbia
country: United States
facility: South Carolina Heart Center
state: South Carolina
city: Nashville
country: United States
facility: Mid-State Cardiology
state: Tennessee
city: Dallas
country: United States
facility: Heart Place/Baylor University of Medicine
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center at Dallas
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Salt Lake CIty
country: United States
facility: University of Utah Medical Ctr.
state: Utah
city: Charlottesville
country: United States
facility: U. OF Virginia/Dept of Cardiology
state: Virginia
city: Fairfax
country: United States
facility: The Cardiovascular Grp./Attn: Mandy Murphy
state: Virginia
city: RIchmond
country: United States
facility: Medical College of VA
state: Virginia
city: Spokane
country: United States
facility: Inland Cardiology/The Heart Inst.
state: Washington
city: Green Bay
country: United States
facility: Cardiology Associates of Green Bay
state: Wisconsin
city: Milwaukee
country: United States
facility: Wisconsin Ctr for Clinical Research
state: Wisconsin
city: Brugge
country: Belgium
facility: A.Z. Sint-Jan, Ruddershove, 10
city: Yvoir
country: Belgium
facility: Clin. Univ. UCL de Mont-Godinne-
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Victoria
country: Canada
facility: Cardiac Arrythmia Trials/Royal Jubilee Hosp.
state: British Columbia
city: Rotterdam
country: Canada
facility: Academisch ZiekenhuisRotterdam, Thoraxentrum Dr. Molewaterplein 40
state: Newfoundland and Labrador
city: St Johns
country: Canada
facility: Health Sciences Ctr
state: Newfoundland and Labrador
city: Zwolle
country: Canada
facility: Isala Klinieken Loc Weezenlanden Afd. Cardiologie Groot Wezenland 20
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: QE II Health Sciences Ctr.
state: Nova Scotia
city: Hamilton
country: Canada
facility: Hamilton General Hospital/McMaster Clinic
state: Ontario
city: Toronto
country: Canada
facility: St Michaels Hospital 30 Bond Street 7-050 Queen
state: Ontario
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Ste-Foy
country: Canada
facility: Laval Hospital
state: Quebec
city: Winnepeg
country: Canada
facility: Winnepeg Health Science Ctr.
city: Lille
country: France
facility: CHRU de Lille-Hopital Cardiologique-Bd du Pr Leclerc
city: Lyon
country: France
facility: Centre hospitalier L. Pradel-28 av. du doyen Lepine
city: Marseille
country: France
facility: Hopital Nord-Chemin Bourrely St Antoine
city: Nancy
country: France
facility: CHRU de Nancy-29 av. de Lattre de Tassigny
city: Nantes
country: France
facility: CHRU de Nantes-Hopital G. et R. Laennec-bd Jacques Monod
city: Paris
country: France
facility: Hopital Lariboisiere-2 rue A. Pare
city: Pessac
country: France
facility: Hopital cardiologique du Haut Leveque-av. de Magellan
city: Rennes
country: France
facility: CHRU de Rennes-Hotel Dieu-2 rue l'hotel Dieu
city: Tours
country: France
facility: CHRU de TOURS-Hopital TROUSSEAU-Chanbray les Tours
city: Bad Bevensen
country: Germany
facility: Herz-kreislauf-Klinik Bevensen AG Kardiologie Akut Romstedter Str. 25
city: Bad Nauheim
country: Germany
facility: Kerckhoff Klinik Abteilung Elektrophysiologie Benekestr. 2
city: Bad Oeynhausen
country: Germany
facility: Herzzentrum NRW Kardiologische Ambulanz Georgstr. 11
city: Berlin
country: Germany
facility: Krankenhaus Am Urban Innere Medizin I (Kardiologie) Dieffenbachstr. 1
city: Berlin
country: Germany
facility: Charite Campus Buch Franz-Vollhard-Klinik Wiltbergstr. 50
city: Berlin
country: Germany
facility: Virchow-Klinikum Franz-Volhard-Klinik Wiltbergstr. 50
city: Bonn
country: Germany
facility: Universitatsklinikum Bonn Medizinische Klinik und Poliklinik II Sigmund-Freud-Str. 25
city: Branderburg an der Havel
country: Germany
facility: Stadtisches Klinikum Brandenburg Medizinische Klinik I Kardiologie Hochstr. 29
city: Coburg
country: Germany
facility: Klinikum Coburg Ketschendorferstr. 33
city: Dusseldorf
country: Germany
facility: Evangelische Krankenhaus Abteilung Kardiologie Kirchfeldstr. 40
city: Dusseldorf
country: Germany
facility: Universitatsklinikum Dusseldorf Klinik fur Kardiologie Moorenstr. 5
city: Frankfurt
country: Germany
facility: Klinikum der Johann-Wolfgang-Goethe-Universitat Medizinische Klinik IV Abteilung Elektrophysiologie Theodor-Stern-Kai 7
city: Freiburg
country: Germany
facility: Medizinische Universitatsklinik
city: Hamburg
country: Germany
facility: Universitats-Krankenhaus Eppendorf Abteilung Kardiologie Martinistr. 52
city: Heidelberg
country: Germany
facility: Medizinische Universitats Klinik Heidelberg Medisin III (Kardiologie) Bergheimerstr. 58
city: Ludwigshafen
country: Germany
facility: Klinikum der Stadt Ludwigshafen Bremserstr. 79
city: Magdeburg
country: Germany
facility: Medizinische Universitatsklinik Leipzigerstr. 44
city: Mannheim
country: Germany
facility: Universitatsklinikum I. Medizinische Klinik Kardiologie/Angiologie/Pneumologie Theodor-Kutzer-Ufer 1-3
city: Munchen
country: Germany
facility: Deutsches Herzzentrum Minchen Lazarettstr. 36
city: Munchen
country: Germany
facility: Klinikum Grobhadern Universitat Munchen Marchioninistr. 15
city: Nurnberg
country: Germany
facility: Stadt. Klinikum Nurnberg-Sud Med. Klinik 8-Kardiologie Kardiologie KH II/8
city: Tubingen
country: Germany
facility: Medizinische Klinik und Poliklinik Universitat Tubingen Ottfried-Muller-Str. 10
city: Wuppertal
country: Germany
facility: Klinikum Wuppwrtal GmbH Klinik Fur Herz-und Thoraxchirugie Arrenbergerstr. 20
city: Bari
country: Italy
facility: Istituto di Malattie cardiovasolari policlinico di bari piazza G Cesare 11
city: Novara
country: Italy
facility: Ospedale Maggiore della carita II Divisione di cardiologia, corso mazzini 18
city: Pavia
country: Italy
facility: Policlinico Matteo Dippartimento di cardiologia Pizza Golgi, 2
city: Roma
country: Italy
facility: Divisione di cardiologia Ospedale s. Flippo Neri, Via Martinotti 20
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum Amsterdam Afd. Cardiologie Meibergdreef 9
city: Eldhoven
country: Netherlands
facility: Catharina Ziekenhuis Afd. Cardiologie Postbus 1350
city: Groningen
country: Netherlands
facility: Academisch Ziekenhuis Groningen Thoraxcentrum Hanzeplein 1
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum Afd. Cardiologie Postbus 9600
city: Nieuwegein
country: Netherlands
facility: SintAntonius Ziekenhuis Afd R&D Cardiologie Koekoekslaan 1
city: Gdansk
country: Poland
facility: ll Klinika Chorob Serca Akademii Medycznej w Gdansku Kieturakisa 1
city: Katowice
country: Poland
facility: 1 Klinka kardiologii Slaska Akademia Medyczna, Ziolowa 47
city: Szczecin
country: Poland
facility: Oddzial kardiologii-Instut kardiologii, Ul Powstancow
city: Warszawa
country: Poland
facility: Instytut Kardiologii Klinika Choroby Wiencowej,ul Spartanka 1
city: Warszawa
country: Poland
facility: Instytut Kardiologii-Klinka Kardiologii Ogolnej, ul. Alpejska 42
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial, Servicio de Cardiologia, Villarroel, 170
city: Madrid
country: Spain
facility: Clinica Puerta de Hierro, San Martin de Porres, 4
city: Madrid
country: Spain
facility: Hospital 12 de Octubre, Carretera de Andalucia, km. 5, 4
city: Malaga
country: Spain
facility: Hospital Virgen de la Victoria, Campus Universitario de Teatinos, s/n
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia, Avenida Blasco Ibanez, 17
Study officials:
affiliation: Procter and Gamble
name: Jose M Brum, MD
role: STUDY_DIRECTOR
References: