AzTrials
AzTrials

ArrhythmiaPhase 3NCT00035490

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

A Phase 3 study testing Azimilide Dihydrochloride in people with Arrhythmia, run by Forest Laboratories at 142 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Arrhythmia
What is being tested?
Azimilide Dihydrochloride
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
633 participants
Where
142 sitesin 9 countries
Study dates
Sep 2001to Apr 2004
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 10Show fewer
  • 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

Trial locations and contacts

142 sites in 9 countries.

142 sites in 9 countries

United States78 sites

  • Mid-Atlantic Cardiovascular Associates

    Baltimore, Maryland, 21204

  • ATC/Cardio Medical Grp

    Beverly Hills, California, 90210

  • St Elizabeth Medical Center

    Boston, Massachusetts, 02135

  • Bridgeport Hospital

    Bridgeport, Connecticut, 06610

  • Brookdale University Hospital

    Brooklyn, New York, 111212

  • Lahey Hitchcock Medical Ctr.

    Burlington, Massachusetts, 01805

  • United HealthNetwork/Ohio Heart Center

    Canton, Ohio, 44718

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Mid Carolina Cardiology

    Charlotte, North Carolina, 28204

  • U. OF Virginia/Dept of Cardiology

    Charlottesville, Virginia, 22908

  • The Lindnar Clinical Trial Center

    Cincinnati, Ohio, 45219

  • University Hospitals of Cleveland

    Cleveland, Ohio, 44106

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Memorial Hospital

    Colorado Springs, Colorado, 80910

  • South Carolina Heart Center

    Columbia, South Carolina, 29204

  • Midwest Cardio Res. Foundation

    Columbus, Ohio, 43214

  • Heart Place/Baylor University of Medicine

    Dallas, Texas, 75246

  • UT Southwestern Medical Center at Dallas

    Dallas, Texas, 75390-9047

  • Dayton Cardiac EP

    Dayton, Ohio, 45406

  • Doylestown Medical Hospital

    Doylestown, Pennsylvania, 18901

  • SMDC Education Research

    Duluth, Minnesota, 55805

  • Duke University Medical Ctr.

    Durham, North Carolina, 27710

  • Cardiovascular Assoc.

    Eugene, Oregon, 97401

  • The Cardiovascular Grp./Attn: Mandy Murphy

    Fairfax, Virginia, 22031

  • Florida Arrythmia Consultants

    Fort Lauderdale, Florida, 33308

  • Southwest Florida Health Group

    Fort Myers, Florida, 33919

  • Cardiology Associates of Green Bay

    Green Bay, Wisconsin, 54301

  • Hershey Med. Ctr.-Div. Cardiology

    Hershey, Pennsylvania, 17033

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Huntington Hospital

    Huntington, New York, 11743

  • University of Iowa Hospital

    Iowa City, Iowa, 52242

  • Jacksonville Heart Center

    Jacksonville, Florida, 32250

  • Cardiology Assoc., PC

    Johnson City, New York, 13797

  • Mid-America Cardiology c/o KU medical Ctr

    Kansas City, Kansas, 66160

  • The Watson Clinic, LLP

    Lakeland, Florida, 33805

  • Lancaster Heart Foundation

    Lancaster, Pennsylvania, 17603

  • Nevada Cardiology

    Las Vegas, Nevada, 89109

  • UAMS Dept of Cardiology

    Little Rock, Arkansas, 72205

  • Loma Linda Univ. Med. Ctr.

    Loma Linda, California, 92354

  • Good Samaritan Hospital

    Los Angeles, California, 90017

  • VA Greater Los Angeles Healthcare System

    Los Angeles, California, 90073

  • University Cardiology

    Louisville, Kentucky, 40202

  • Louisville Cardiology Medical Group, PSC

    Louisville, Kentucky, 40207

  • Loyola University Med. Ctr.

    Maywood, Illinois, 60153

  • Tri-City Cardiology Consultants, P.C.

    Mesa, Arizona, 85206

  • Univ. Miami Jackson Mem. med. Ctr.

    Miami, Florida, 33136

  • Wisconsin Ctr for Clinical Research

    Milwaukee, Wisconsin, 53215

  • University of Minnesota-Cardiology

    Minneapolis, Minnesota, 55455

  • The Heart Group

    Mobile, Alabama, 36608

  • Morristown Memorial Hospital

    Morristown, New Jersey, 07962

  • Mid-State Cardiology

    Nashville, Tennessee, 37203

  • St. Lukes/Roosevelt Hospital Center

    New York, New York, 10025

  • The Mt Sinai Medical Ctr.

    New York, New York, 10029

  • Florida Heart Institute

    Orlando, Florida, 32803

  • Memorial Health Systems/Cardiology Research Associates

    Ormond Beach, Florida, 32174

  • Atlantic Health Systems

    Passaic, New Jersey, 07055

  • Blackstone Cardiology Assoc. P.C.

    Pawtucket, Rhode Island, 02860

  • Univ of PA/Presbyterian Hospital

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Barry Alpert, MD, FACC

    Pittsburgh, Pennsylvania, 15224

  • Maine Cardiology Assoc.

    Portland, Maine, 04102

  • Medical College of VA

    Richmond, Virginia, 23219

  • Rochester Cardiopulmonary Group

    Rochester, New York, 14621

  • University of Rochester Strong mem. Hospital

    Rochester, New York, 14642

  • Regional Cardiology Associates

    Sacramento, California, 95819

  • University of Utah Medical Ctr.

    Salt Lake City, Utah, 84132

  • Cardiac Arrythmia Associates

    San Diego, California, 92037

  • UCSD Medical Center

    San Diego, California, 92103

  • LSU Health Sciences Center

    Shreveport, Louisiana, 71130

  • Inland Cardiology/The Heart Inst.

    Spokane, Washington, 99204

  • Baystate Medical Center-Cardiology Research

    Springfield, Massachusetts, 01199

  • Medical College of Ohio

    Toledo, Ohio, 43614

  • Oklahoma Heart Institute

    Tulsa, Oklahoma, 74104

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Arrhythmia and Pacemaker Consultants

    West Orange, New Jersey, 07052

  • Buffalo Cardiology & Pulmonary Assoc.

    Williamsville, New York, 14221

  • Wake Forest School of Medicine

    Winston-Salem, North Carolina, 27157

  • University of Mass. Medical Ctr. Division of Cardiovascular Medicine

    Worcester, Massachusetts, 01655

Other trials in United States

Germany23 sites

  • Herz-kreislauf-Klinik Bevensen AG Kardiologie Akut Romstedter Str. 25

    Bad Bevensen, 29549

  • Kerckhoff Klinik Abteilung Elektrophysiologie Benekestr. 2

    Bad Nauheim, 61230

  • Herzzentrum NRW Kardiologische Ambulanz Georgstr. 11

    Bad Oeynhausen, 32545

  • Krankenhaus Am Urban Innere Medizin I (Kardiologie) Dieffenbachstr. 1

    Berlin, 10967

  • Charite Campus Buch Franz-Vollhard-Klinik Wiltbergstr. 50

    Berlin, 13125

  • Virchow-Klinikum Franz-Volhard-Klinik Wiltbergstr. 50

    Berlin, 13125

  • Universitatsklinikum Bonn Medizinische Klinik und Poliklinik II Sigmund-Freud-Str. 25

    Bonn, 53105

  • Stadtisches Klinikum Brandenburg Medizinische Klinik I Kardiologie Hochstr. 29

    Branderburg An Der Havel, 14770

  • Klinikum Coburg Ketschendorferstr. 33

    Coburg, 96450

  • Evangelische Krankenhaus Abteilung Kardiologie Kirchfeldstr. 40

    Düsseldorf, 40217

  • Universitatsklinikum Dusseldorf Klinik fur Kardiologie Moorenstr. 5

    Düsseldorf, 40225

  • Klinikum der Johann-Wolfgang-Goethe-Universitat Medizinische Klinik IV Abteilung Elektrophysiologie Theodor-Stern-Kai 7

    Frankfurt, M. 60590

  • Medizinische Universitatsklinik

    Freiburg im Breisgau, 79106

  • Universitats-Krankenhaus Eppendorf Abteilung Kardiologie Martinistr. 52

    Hamburg, 20246

  • Medizinische Universitats Klinik Heidelberg Medisin III (Kardiologie) Bergheimerstr. 58

    Heidelberg, 69115

  • Klinikum der Stadt Ludwigshafen Bremserstr. 79

    Ludwigshafen, 67063

  • Medizinische Universitatsklinik Leipzigerstr. 44

    Magdeburg, 39120

  • Universitatsklinikum I. Medizinische Klinik Kardiologie/Angiologie/Pneumologie Theodor-Kutzer-Ufer 1-3

    Mannheim, 68135

  • Deutsches Herzzentrum Minchen Lazarettstr. 36

    München, 80636

  • Klinikum Grobhadern Universitat Munchen Marchioninistr. 15

    München, 81377

  • Stadt. Klinikum Nurnberg-Sud Med. Klinik 8-Kardiologie Kardiologie KH II/8

    Nuremberg, 90471

  • Medizinische Klinik und Poliklinik Universitat Tubingen Ottfried-Muller-Str. 10

    Tübingen, 72076

  • Klinikum Wuppwrtal GmbH Klinik Fur Herz-und Thoraxchirugie Arrenbergerstr. 20

    Wuppertal, 42117

Other trials in Germany

Canada11 sites

  • University of Alberta Hospital

    Edmonton, Alberta, T6G-2B7

  • QE II Health Sciences Ctr.

    Halifax, Nova Scotia, B3K-3A7

  • Hamilton General Hospital/McMaster Clinic

    Hamilton, Ontario, L8L-2X2

  • Montreal Heart Institute

    Montreal, Quebec, H1T 1C8

  • Academisch ZiekenhuisRotterdam, Thoraxentrum Dr. Molewaterplein 40

    Rotterdam, Newfoundland and Labrador, 3015 GD

  • Health Sciences Ctr

    St. John's, Newfoundland and Labrador, A1B-3V6

  • Laval Hospital

    Ste-Foy, Quebec, G1V-4G5

  • St Michaels Hospital 30 Bond Street 7-050 Queen

    Toronto, Ontario, M5B-1W8

  • Cardiac Arrythmia Trials/Royal Jubilee Hosp.

    Victoria, British Columbia, V8R-4R2

  • Winnepeg Health Science Ctr.

    Winnepeg, R3E 0Z3

  • Isala Klinieken Loc Weezenlanden Afd. Cardiologie Groot Wezenland 20

    Zwolle, Newfoundland and Labrador, 8011JW

Other trials in Canada

France9 sites

  • CHRU de Lille-Hopital Cardiologique-Bd du Pr Leclerc

    Lille, CEDEX 59 037-

  • Centre hospitalier L. Pradel-28 av. du doyen Lepine

    Lyon, CEDEX 3-69 394

  • Hopital Nord-Chemin Bourrely St Antoine

    Marseille, CEDEX 20 13915

  • CHRU de Nancy-29 av. de Lattre de Tassigny

    Nancy, CEDEX 54 035

  • CHRU de Nantes-Hopital G. et R. Laennec-bd Jacques Monod

    Nantes, CEDEX 44 093

  • Hopital Lariboisiere-2 rue A. Pare

    Paris, CEDEX 75010

  • Hopital cardiologique du Haut Leveque-av. de Magellan

    Pessac, CEDEX-33 604

  • CHRU de Rennes-Hotel Dieu-2 rue l'hotel Dieu

    Rennes, CEDEX 35 033

  • CHRU de TOURS-Hopital TROUSSEAU-Chanbray les Tours

    Tours, CEDEX-37044

Other trials in France

Netherlands5 sites

  • Academisch Medisch Centrum Amsterdam Afd. Cardiologie Meibergdreef 9

    Amsterdam, 1105AZ

  • Catharina Ziekenhuis Afd. Cardiologie Postbus 1350

    Eldhoven, 5602ZA

  • Academisch Ziekenhuis Groningen Thoraxcentrum Hanzeplein 1

    Groningen, 9713GZ

  • Leids Universitair Medisch Centrum Afd. Cardiologie Postbus 9600

    Leiden, 2300 RC

  • SintAntonius Ziekenhuis Afd R&D Cardiologie Koekoekslaan 1

    Nieuwegein, 3435CM

Other trials in Netherlands

Poland5 sites

  • ll Klinika Chorob Serca Akademii Medycznej w Gdansku Kieturakisa 1

    Gdansk, 80742

  • 1 Klinka kardiologii Slaska Akademia Medyczna, Ziolowa 47

    Katowice, 40 635

  • Oddzial kardiologii-Instut kardiologii, Ul Powstancow

    Szczecin, 70111

  • Instytut Kardiologii Klinika Choroby Wiencowej,ul Spartanka 1

    Warsaw, 02637

  • Instytut Kardiologii-Klinka Kardiologii Ogolnej, ul. Alpejska 42

    Warsaw, 04628

Other trials in Poland

Spain5 sites

  • Hospital Clinic i Provincial, Servicio de Cardiologia, Villarroel, 170

    Barcelona, 8036

  • Clinica Puerta de Hierro, San Martin de Porres, 4

    Madrid, 28035

  • Hospital 12 de Octubre, Carretera de Andalucia, km. 5, 4

    Madrid, 28041

  • Hospital Virgen de la Victoria, Campus Universitario de Teatinos, s/n

    Málaga, 29010

  • Hospital Clinico Universitario de Valencia, Avenida Blasco Ibanez, 17

    Valencia, 46010

Other trials in Spain

Italy4 sites

  • Istituto di Malattie cardiovasolari policlinico di bari piazza G Cesare 11

    Bari, 70120

  • Ospedale Maggiore della carita II Divisione di cardiologia, corso mazzini 18

    Novara, 28100

  • Policlinico Matteo Dippartimento di cardiologia Pizza Golgi, 2

    Pavia, 27100

  • Divisione di cardiologia Ospedale s. Flippo Neri, Via Martinotti 20

    Roma, 168

Other trials in Italy

Belgium2 sites

  • A.Z. Sint-Jan, Ruddershove, 10

    Bruges, 8000

  • Clin. Univ. UCL de Mont-Godinne-

    Yvoir, 5530

Other trials in Belgium

About this study

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.

Conditions
Arrhythmia
Being tested
Azimilide Dihydrochloride, placebo
Medical subject headings
Arrhythmias, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Azimilide DihydrochlorideDrug

    125 mg azimilide, once a day for one year

  • placeboDrug

    placebo tablet, once daily for one year

  • Azimilide DihydrochlorideDrug

    75 mg azimilide, once a day for one year

Study groups in NCT00035490
Study groupRoleWhat they receive
1Placebo comparatorPlacebo tablets
Receives: Drug: placebo
2Experimental75 mg azimilide
Receives: Drug: Azimilide Dihydrochloride
3Experimental125 mg azimilide
Receives: Drug: Azimilide Dihydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reducing the recurrence of all-cause shocks plus symptomatic ATP

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2002 (estimated)
  2. Study startSep 2001
  3. Primary completionApr 2004
  4. Study completionApr 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
633 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00035490
Sponsor's protocol ID
2000098
Status last verified
Sep 2011
First submitted
3 May 2002
Last updated
3 Oct 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Azimilide Dihydrochloride in people with Arrhythmia, run by Forest Laboratories at 142 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 142 sites in United States, Germany, Canada, France, Netherlands and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reducing the recurrence of all-cause shocks plus symptomatic ATP (time frame: one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00035490.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2011.

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