Efficacy and Safety Evaluation of Azimilide Dihydrochloride in Patients With Implantable Cardioverter Defibrillators

September 30, 2011 updated by: Forest Laboratories

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

633

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brugge, Belgium, 8000
        • A.Z. Sint-Jan, Ruddershove, 10
      • Yvoir, Belgium, 5530
        • Clin. Univ. UCL de Mont-Godinne-
  • Canada
      • Winnepeg, Canada, R3E 0Z3
        • Winnepeg Health Science Ctr.
    • Alberta
      • Edmonton, Alberta, Canada, T6G-2B7
        • University of Alberta Hospital
    • British Columbia
      • Victoria, British Columbia, Canada, V8R-4R2
        • Cardiac Arrythmia Trials/Royal Jubilee Hosp.
    • Newfoundland and Labrador
      • Rotterdam, Newfoundland and Labrador, Canada, 3015 GD
        • Academisch ZiekenhuisRotterdam, Thoraxentrum Dr. Molewaterplein 40
      • St Johns, Newfoundland and Labrador, Canada, A1B-3V6
        • Health Sciences Ctr
      • Zwolle, Newfoundland and Labrador, Canada, 8011JW
        • Isala Klinieken Loc Weezenlanden Afd. Cardiologie Groot Wezenland 20
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K-3A7
        • QE II Health Sciences Ctr.
    • Ontario
      • Hamilton, Ontario, Canada, L8L-2X2
        • Hamilton General Hospital/McMaster Clinic
      • Toronto, Ontario, Canada, M5B-1W8
        • St Michaels Hospital 30 Bond Street 7-050 Queen
    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8
        • Montreal Heart Institute
      • Ste-Foy, Quebec, Canada, G1V-4G5
        • Laval Hospital
  • France
      • Lille, France, CEDEX 59 037-
        • CHRU de Lille-Hopital Cardiologique-Bd du Pr Leclerc
      • Lyon, France, CEDEX 3-69 394
        • Centre hospitalier L. Pradel-28 av. du doyen Lepine
      • Marseille, France, CEDEX 20 13915
        • Hopital Nord-Chemin Bourrely St Antoine
      • Nancy, France, CEDEX 54 035
        • CHRU de Nancy-29 av. de Lattre de Tassigny
      • Nantes, France, CEDEX 44 093
        • CHRU de Nantes-Hopital G. et R. Laennec-bd Jacques Monod
      • Paris, France, CEDEX 75010
        • Hopital Lariboisiere-2 rue A. Pare
      • Pessac, France, CEDEX-33 604
        • Hopital cardiologique du Haut Leveque-av. de Magellan
      • Rennes, France, CEDEX 35 033
        • CHRU de Rennes-Hotel Dieu-2 rue l'hotel Dieu
      • Tours, France, CEDEX-37044
        • CHRU de TOURS-Hopital TROUSSEAU-Chanbray les Tours
  • Germany
      • Bad Bevensen, Germany, 29549
        • Herz-kreislauf-Klinik Bevensen AG Kardiologie Akut Romstedter Str. 25
      • Bad Nauheim, Germany, 61230
        • Kerckhoff Klinik Abteilung Elektrophysiologie Benekestr. 2
      • Bad Oeynhausen, Germany, 32545
        • Herzzentrum NRW Kardiologische Ambulanz Georgstr. 11
      • Berlin, Germany, 10967
        • Krankenhaus Am Urban Innere Medizin I (Kardiologie) Dieffenbachstr. 1
      • Berlin, Germany, 13125
        • Charite Campus Buch Franz-Vollhard-Klinik Wiltbergstr. 50
      • Berlin, Germany, 13125
        • Virchow-Klinikum Franz-Volhard-Klinik Wiltbergstr. 50
      • Bonn, Germany, 53105
        • Universitatsklinikum Bonn Medizinische Klinik und Poliklinik II Sigmund-Freud-Str. 25
      • Branderburg an der Havel, Germany, 14770
        • Stadtisches Klinikum Brandenburg Medizinische Klinik I Kardiologie Hochstr. 29
      • Coburg, Germany, 96450
        • Klinikum Coburg Ketschendorferstr. 33
      • Dusseldorf, Germany, 40217
        • Evangelische Krankenhaus Abteilung Kardiologie Kirchfeldstr. 40
      • Dusseldorf, Germany, 40225
        • Universitatsklinikum Dusseldorf Klinik fur Kardiologie Moorenstr. 5
      • Frankfurt, Germany, M. 60590
        • Klinikum der Johann-Wolfgang-Goethe-Universitat Medizinische Klinik IV Abteilung Elektrophysiologie Theodor-Stern-Kai 7
      • Freiburg, Germany, 79106
        • Medizinische Universitätsklinik
      • Hamburg, Germany, 20246
        • Universitats-Krankenhaus Eppendorf Abteilung Kardiologie Martinistr. 52
      • Heidelberg, Germany, 69115
        • Medizinische Universitats Klinik Heidelberg Medisin III (Kardiologie) Bergheimerstr. 58
      • Ludwigshafen, Germany, 67063
        • Klinikum der Stadt Ludwigshafen Bremserstr. 79
      • Magdeburg, Germany, 39120
        • Medizinische Universitatsklinik Leipzigerstr. 44
      • Mannheim, Germany, 68135
        • Universitatsklinikum I. Medizinische Klinik Kardiologie/Angiologie/Pneumologie Theodor-Kutzer-Ufer 1-3
      • Munchen, Germany, 80636
        • Deutsches Herzzentrum Minchen Lazarettstr. 36
      • Munchen, Germany, 81377
        • Klinikum Grobhadern Universitat Munchen Marchioninistr. 15
      • Nurnberg, Germany, 90471
        • Stadt. Klinikum Nurnberg-Sud Med. Klinik 8-Kardiologie Kardiologie KH II/8
      • Tubingen, Germany, 72076
        • Medizinische Klinik und Poliklinik Universitat Tubingen Ottfried-Muller-Str. 10
      • Wuppertal, Germany, 42117
        • Klinikum Wuppwrtal GmbH Klinik Fur Herz-und Thoraxchirugie Arrenbergerstr. 20
  • Italy
      • Bari, Italy, 70120
        • Istituto di Malattie cardiovasolari policlinico di bari piazza G Cesare 11
      • Novara, Italy, 28100
        • Ospedale Maggiore della carita II Divisione di cardiologia, corso mazzini 18
      • Pavia, Italy, 27100
        • Policlinico Matteo Dippartimento di cardiologia Pizza Golgi, 2
      • Roma, Italy, 168
        • Divisione di cardiologia Ospedale s. Flippo Neri, Via Martinotti 20
  • Netherlands
      • Amsterdam, Netherlands, 1105AZ
        • Academisch Medisch Centrum Amsterdam Afd. Cardiologie Meibergdreef 9
      • Eldhoven, Netherlands, 5602ZA
        • Catharina Ziekenhuis Afd. Cardiologie Postbus 1350
      • Groningen, Netherlands, 9713GZ
        • Academisch Ziekenhuis Groningen Thoraxcentrum Hanzeplein 1
      • Leiden, Netherlands, 2300 RC
        • Leids Universitair Medisch Centrum Afd. Cardiologie Postbus 9600
      • Nieuwegein, Netherlands, 3435CM
        • SintAntonius Ziekenhuis Afd R&D Cardiologie Koekoekslaan 1
  • Poland
      • Gdansk, Poland, 80742
        • ll Klinika Chorob Serca Akademii Medycznej w Gdansku Kieturakisa 1
      • Katowice, Poland, 40 635
        • 1 Klinka kardiologii Slaska Akademia Medyczna, Ziolowa 47
      • Szczecin, Poland, 70111
        • Oddzial kardiologii-Instut kardiologii, Ul Powstancow
      • Warszawa, Poland, 02637
        • Instytut Kardiologii Klinika Choroby Wiencowej,ul Spartanka 1
      • Warszawa, Poland, 04628
        • Instytut Kardiologii-Klinka Kardiologii Ogolnej, ul. Alpejska 42
  • Spain
      • Barcelona, Spain, 8036
        • Hospital Clinic i Provincial, Servicio de Cardiologia, Villarroel, 170
      • Madrid, Spain, 28035
        • Clinica Puerta de Hierro, San Martin de Porres, 4
      • Madrid, Spain, 28041
        • Hospital 12 de Octubre, Carretera de Andalucia, km. 5, 4
      • Malaga, Spain, 29010
        • Hospital Virgen de la Victoria, Campus Universitario de Teatinos, s/n
      • Valencia, Spain, 46010
        • Hospital Clinico Universitario de Valencia, Avenida Blasco Ibanez, 17
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • The Heart Group
    • Arizona
      • Mesa, Arizona, United States, 85206
        • Tri-City Cardiology Consultants, P.C.
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • UAMS Dept of Cardiology
    • California
      • Beverly Hills, California, United States, 90210
        • ATC/Cardio Medical Grp
      • Loma Linda, California, United States, 92354
        • Loma Linda Univ. Med. Ctr.
      • Los Angeles, California, United States, 90073
        • VA Greater Los Angeles Healthcare System
      • Los Angeles, California, United States, 90017
        • Good Samaritan Hospital
      • Sacramento, California, United States, 95819
        • Regional Cardiology Associates
      • San Diego, California, United States, 92103
        • UCSD Medical Center
      • San Diego, California, United States, 92037
        • Cardiac Arrythmia Associates
    • Colorado
      • Colorado Springs, Colorado, United States, 80910
        • Memorial Hospital
    • Connecticut
      • Bridgeport, Connecticut, United States, 06610
        • Bridgeport Hospital
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Hospital Center
    • Florida
      • Fort Myers, Florida, United States, 33919
        • Southwest Florida Health Group
      • Ft Lauderdale, Florida, United States, 33308
        • Florida Arrythmia Consultants
      • Jacksonville, Florida, United States, 32250
        • Jacksonville Heart Center
      • Lakeland, Florida, United States, 33805
        • The Watson Clinic, LLP
      • MIami, Florida, United States, 33136
        • Univ. Miami Jackson Mem. med. Ctr.
      • ORmond Beach, Florida, United States, 32174
        • Memorial Health Systems/Cardiology Research Associates
      • Orlando, Florida, United States, 32803
        • Florida Heart Institute
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Loyola University Med. Ctr.
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospital
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Mid-America Cardiology c/o KU medical Ctr
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University Cardiology
      • Louisville, Kentucky, United States, 40207
        • Louisville Cardiology Medical Group, PSC
    • Louisiana
      • Shreveport, Louisiana, United States, 71130
        • LSU Health Sciences Center
    • Maine
      • Portland, Maine, United States, 04102
        • Maine Cardiology Assoc.
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Mid-Atlantic Cardiovascular Associates
    • Massachusetts
      • Boston, Massachusetts, United States, 02135
        • St Elizabeth Medical Center
      • Burlington, Massachusetts, United States, 01805
        • Lahey Hitchcock Medical Ctr.
      • Springfield, Massachusetts, United States, 01199
        • Baystate Medical Center-Cardiology Research
      • Worcester, Massachusetts, United States, 01655
        • University of Mass. Medical Ctr. Division of Cardiovascular Medicine
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • SMDC Education Research
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota-Cardiology
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Nevada Cardiology
    • New Jersey
      • Morristown, New Jersey, United States, 07962
        • Morristown Memorial Hospital
      • Passaic, New Jersey, United States, 07055
        • Atlantic Health Systems
      • West Orange, New Jersey, United States, 07052
        • Arrhythmia and Pacemaker Consultants
    • New York
      • Brooklyn, New York, United States, 111212
        • Brookdale University Hospital
      • Huntington, New York, United States, 11743
        • Huntington Hospital
      • Johnson City, New York, United States, 13797
        • Cardiology Assoc., PC
      • New York, New York, United States, 10025
        • St. Lukes/Roosevelt Hospital Center
      • New York, New York, United States, 10029
        • The Mt Sinai Medical Ctr.
      • Rochester, New York, United States, 14621
        • Rochester Cardiopulmonary Group
      • Rochester, New York, United States, 14642
        • University of Rochester Strong mem. Hospital
      • Williamsville, New York, United States, 14221
        • Buffalo Cardiology & Pulmonary Assoc.
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Mid Carolina Cardiology
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Ctr.
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest School of Medicine
    • Ohio
      • Canton, Ohio, United States, 44718
        • United HealthNetwork/Ohio Heart Center
      • Cincinnati, Ohio, United States, 45219
        • The Lindnar Clinical Trial Center
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Cleveland, Ohio, United States, 44106
        • University Hospitals of Cleveland
      • Columbus, Ohio, United States, 43214
        • Midwest Cardio Res. Foundation
      • Dayton, Ohio, United States, 45406
        • Dayton Cardiac EP
      • Toledo, Ohio, United States, 43614
        • Medical College of Ohio
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Oklahoma Heart Institute
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Cardiovascular Assoc.
    • Pennsylvania
      • Doylestown, Pennsylvania, United States, 18901
        • Doylestown Medical Hospital
      • Hershey, Pennsylvania, United States, 17033
        • Hershey Med. Ctr.-Div. Cardiology
      • Lancaster, Pennsylvania, United States, 17603
        • Lancaster Heart Foundation
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
      • Philadelphia, Pennsylvania, United States, 19104
        • Univ of PA/Presbyterian Hospital
      • Pittsburgh, Pennsylvania, United States, 15224
        • Barry Alpert, MD, FACC
    • Rhode Island
      • Pawtucket, Rhode Island, United States, 02860
        • Blackstone Cardiology Assoc. P.C.
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
      • Columbia, South Carolina, United States, 29204
        • South Carolina Heart Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Mid-State Cardiology
    • Texas
      • Dallas, Texas, United States, 75246
        • Heart Place/Baylor University of Medicine
      • Dallas, Texas, United States, 75390-9047
        • UT Southwestern Medical Center at Dallas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
    • Utah
      • Salt Lake CIty, Utah, United States, 84132
        • University of Utah Medical Ctr.
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • U. OF Virginia/Dept of Cardiology
      • Fairfax, Virginia, United States, 22031
        • The Cardiovascular Grp./Attn: Mandy Murphy
      • RIchmond, Virginia, United States, 23219
        • Medical College of VA
    • Washington
      • Spokane, Washington, United States, 99204
        • Inland Cardiology/The Heart Inst.
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54301
        • Cardiology Associates of Green Bay
      • Milwaukee, Wisconsin, United States, 53215
        • Wisconsin Ctr for Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 1
Placebo tablets
Drug: placebo
placebo tablet, once daily for one year
EXPERIMENTAL: 2
75 mg azimilide
Drug: Azimilide Dihydrochloride
125 mg azimilide, once a day for one year
Drug: Azimilide Dihydrochloride
75 mg azimilide, once a day for one year
EXPERIMENTAL: 3
125 mg azimilide
Drug: Azimilide Dihydrochloride
125 mg azimilide, once a day for one year
Drug: Azimilide Dihydrochloride
75 mg azimilide, once a day for one year

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reducing the recurrence of all-cause shocks plus symptomatic ATP
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Forest Laboratories

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2001

Primary Completion (ACTUAL)

April 1, 2004

Study Completion (ACTUAL)

April 1, 2004

Study Registration Dates

First Submitted

May 3, 2002

First Submitted That Met QC Criteria

May 3, 2002

First Posted (ESTIMATE)

May 6, 2002

Study Record Updates

Last Update Posted (ESTIMATE)

October 3, 2011

Last Update Submitted That Met QC Criteria

September 30, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000098

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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