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

NCT00035490 | Completed Phase 3

• 1 other identifier: 2000098
• Study Type: interventional
• Target: 633
• Locations: 9 countries
• Sites: 142

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.

Conditions

Arrhythmia

Outcome Measures

Primary Outcomes (1)

• Reducing the recurrence of all-cause shocks plus symptomatic ATP

  one year

Study Arms (3)

1

PLACEBO COMPARATOR

Placebo tablets

Drug: placebo

2

EXPERIMENTAL

75 mg azimilide

Drug: Azimilide Dihydrochloride

3

EXPERIMENTAL

125 mg azimilide

Drug: Azimilide Dihydrochloride

Interventions

Azimilide Dihydrochloride DRUG

125 mg azimilide, once a day for one year

3

placebo DRUG

placebo tablet, once daily for one year

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Forest Laboratories: lead

Study Sites (142)

The Heart Group

Mobile, Alabama, 36608, United States

Location

Tri-City Cardiology Consultants, P.C.

Mesa, Arizona, 85206, United States

Location

UAMS Dept of Cardiology

Little Rock, Arkansas, 72205, United States

Location

ATC/Cardio Medical Grp

Beverly Hills, California, 90210, United States

Location

Loma Linda Univ. Med. Ctr.

Loma Linda, California, 92354, United States

Location

Good Samaritan Hospital

Los Angeles, California, 90017, United States

Location

VA Greater Los Angeles Healthcare System

Los Angeles, California, 90073, United States

Location

Regional Cardiology Associates

Sacramento, California, 95819, United States

Location

Cardiac Arrythmia Associates

San Diego, California, 92037, United States

Location

UCSD Medical Center

San Diego, California, 92103, United States

Location

Memorial Hospital

Colorado Springs, Colorado, 80910, United States

Location

Bridgeport Hospital

Bridgeport, Connecticut, 06610, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Florida Arrythmia Consultants

Fort Lauderdale, Florida, 33308, United States

Location

Southwest Florida Health Group

Fort Myers, Florida, 33919, United States

Location

Jacksonville Heart Center

Jacksonville, Florida, 32250, United States

Location

The Watson Clinic, LLP

Lakeland, Florida, 33805, United States

Location

Univ. Miami Jackson Mem. med. Ctr.

Miami, Florida, 33136, United States

Location

Florida Heart Institute

Orlando, Florida, 32803, United States

Location

Memorial Health Systems/Cardiology Research Associates

Ormond Beach, Florida, 32174, United States

Location

Loyola University Med. Ctr.

Maywood, Illinois, 60153, United States

Location

University of Iowa Hospital

Iowa City, Iowa, 52242, United States

Location

Mid-America Cardiology c/o KU medical Ctr

Kansas City, Kansas, 66160, United States

Location

University Cardiology

Louisville, Kentucky, 40202, United States

Location

Louisville Cardiology Medical Group, PSC

Louisville, Kentucky, 40207, United States

Location

LSU Health Sciences Center

Shreveport, Louisiana, 71130, United States

Location

Maine Cardiology Assoc.

Portland, Maine, 04102, United States

Location

Mid-Atlantic Cardiovascular Associates

Baltimore, Maryland, 21204, United States

Location

St Elizabeth Medical Center

Boston, Massachusetts, 02135, United States

Location

Lahey Hitchcock Medical Ctr.

Burlington, Massachusetts, 01805, United States

Location

Baystate Medical Center-Cardiology Research

Springfield, Massachusetts, 01199, United States

Location

University of Mass. Medical Ctr. Division of Cardiovascular Medicine

Worcester, Massachusetts, 01655, United States

Location

SMDC Education Research

Duluth, Minnesota, 55805, United States

Location

University of Minnesota-Cardiology

Minneapolis, Minnesota, 55455, United States

Location

Nevada Cardiology

Las Vegas, Nevada, 89109, United States

Location

Morristown Memorial Hospital

Morristown, New Jersey, 07962, United States

Location

Atlantic Health Systems

Passaic, New Jersey, 07055, United States

Location

Arrhythmia and Pacemaker Consultants

West Orange, New Jersey, 07052, United States

Location

Brookdale University Hospital

Brooklyn, New York, 111212, United States

Location

Huntington Hospital

Huntington, New York, 11743, United States

Location

Cardiology Assoc., PC

Johnson City, New York, 13797, United States

Location

St. Lukes/Roosevelt Hospital Center

New York, New York, 10025, United States

Location

The Mt Sinai Medical Ctr.

New York, New York, 10029, United States

Location

Rochester Cardiopulmonary Group

Rochester, New York, 14621, United States

Location

University of Rochester Strong mem. Hospital

Rochester, New York, 14642, United States

Location

Buffalo Cardiology & Pulmonary Assoc.

Williamsville, New York, 14221, United States

Location

Mid Carolina Cardiology

Charlotte, North Carolina, 28204, United States

Location

Duke University Medical Ctr.

Durham, North Carolina, 27710, United States

Location

Wake Forest School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

United HealthNetwork/Ohio Heart Center

Canton, Ohio, 44718, United States

Location

The Lindnar Clinical Trial Center

Cincinnati, Ohio, 45219, United States

Location

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Midwest Cardio Res. Foundation

Columbus, Ohio, 43214, United States

Location

Dayton Cardiac EP

Dayton, Ohio, 45406, United States

Location

Medical College of Ohio

Toledo, Ohio, 43614, United States

Location

Oklahoma Heart Institute

Tulsa, Oklahoma, 74104, United States

Location

Cardiovascular Assoc.

Eugene, Oregon, 97401, United States

Location

Doylestown Medical Hospital

Doylestown, Pennsylvania, 18901, United States

Location

Hershey Med. Ctr.-Div. Cardiology

Hershey, Pennsylvania, 17033, United States

Location

Lancaster Heart Foundation

Lancaster, Pennsylvania, 17603, United States

Location

Univ of PA/Presbyterian Hospital

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Barry Alpert, MD, FACC

Pittsburgh, Pennsylvania, 15224, United States

Location

Blackstone Cardiology Assoc. P.C.

Pawtucket, Rhode Island, 02860, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

South Carolina Heart Center

Columbia, South Carolina, 29204, United States

Location

Mid-State Cardiology

Nashville, Tennessee, 37203, United States

Location

Heart Place/Baylor University of Medicine

Dallas, Texas, 75246, United States

Location

UT Southwestern Medical Center at Dallas

Dallas, Texas, 75390-9047, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

University of Utah Medical Ctr.

Salt Lake City, Utah, 84132, United States

Location

U. OF Virginia/Dept of Cardiology

Charlottesville, Virginia, 22908, United States

Location

The Cardiovascular Grp./Attn: Mandy Murphy

Fairfax, Virginia, 22031, United States

Location

Medical College of VA

Richmond, Virginia, 23219, United States

Location

Inland Cardiology/The Heart Inst.

Spokane, Washington, 99204, United States

Location

Cardiology Associates of Green Bay

Green Bay, Wisconsin, 54301, United States

Location

Wisconsin Ctr for Clinical Research

Milwaukee, Wisconsin, 53215, United States

Location

A.Z. Sint-Jan, Ruddershove, 10

Bruges, 8000, Belgium

Location

Clin. Univ. UCL de Mont-Godinne-

Yvoir, 5530, Belgium

Location

University of Alberta Hospital

Edmonton, Alberta, T6G-2B7, Canada

Location

Cardiac Arrythmia Trials/Royal Jubilee Hosp.

Victoria, British Columbia, V8R-4R2, Canada

Location

Academisch ZiekenhuisRotterdam, Thoraxentrum Dr. Molewaterplein 40

Rotterdam, Newfoundland and Labrador, 3015 GD, Canada

Location

Health Sciences Ctr

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

Location

Isala Klinieken Loc Weezenlanden Afd. Cardiologie Groot Wezenland 20

Zwolle, Newfoundland and Labrador, 8011JW, Canada

Location

QE II Health Sciences Ctr.

Halifax, Nova Scotia, B3K-3A7, Canada

Location

Hamilton General Hospital/McMaster Clinic

Hamilton, Ontario, L8L-2X2, Canada

Location

St Michaels Hospital 30 Bond Street 7-050 Queen

Toronto, Ontario, M5B-1W8, Canada

Location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

Laval Hospital

Ste-Foy, Quebec, G1V-4G5, Canada

Location

Winnepeg Health Science Ctr.

Winnepeg, R3E 0Z3, Canada

Location

CHRU de Lille-Hopital Cardiologique-Bd du Pr Leclerc

Lille, CEDEX 59 037-, France

Location

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

Lyon, CEDEX 3-69 394, France

Location

Hopital Nord-Chemin Bourrely St Antoine

Marseille, CEDEX 20 13915, France

Location

CHRU de Nancy-29 av. de Lattre de Tassigny

Nancy, CEDEX 54 035, France

Location

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

Nantes, CEDEX 44 093, France

Location

Hopital Lariboisiere-2 rue A. Pare

Paris, CEDEX 75010, France

Location

Hopital cardiologique du Haut Leveque-av. de Magellan

Pessac, CEDEX-33 604, France

Location

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

Rennes, CEDEX 35 033, France

Location

CHRU de TOURS-Hopital TROUSSEAU-Chanbray les Tours

Tours, CEDEX-37044, France

Location

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

Bad Bevensen, 29549, Germany

Location

Kerckhoff Klinik Abteilung Elektrophysiologie Benekestr. 2

Bad Nauheim, 61230, Germany

Location

Herzzentrum NRW Kardiologische Ambulanz Georgstr. 11

Bad Oeynhausen, 32545, Germany

Location

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

Berlin, 10967, Germany

Location

Charite Campus Buch Franz-Vollhard-Klinik Wiltbergstr. 50

Berlin, 13125, Germany

Location

Virchow-Klinikum Franz-Volhard-Klinik Wiltbergstr. 50

Berlin, 13125, Germany

Location

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

Bonn, 53105, Germany

Location

Stadtisches Klinikum Brandenburg Medizinische Klinik I Kardiologie Hochstr. 29

Branderburg An Der Havel, 14770, Germany

Location

Klinikum Coburg Ketschendorferstr. 33

Coburg, 96450, Germany

Location

Evangelische Krankenhaus Abteilung Kardiologie Kirchfeldstr. 40

Düsseldorf, 40217, Germany

Location

Universitatsklinikum Dusseldorf Klinik fur Kardiologie Moorenstr. 5

Düsseldorf, 40225, Germany

Location

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

Frankfurt, M. 60590, Germany

Location

Medizinische Universitatsklinik

Freiburg im Breisgau, 79106, Germany

Location

Universitats-Krankenhaus Eppendorf Abteilung Kardiologie Martinistr. 52

Hamburg, 20246, Germany

Location

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

Heidelberg, 69115, Germany

Location

Klinikum der Stadt Ludwigshafen Bremserstr. 79

Ludwigshafen, 67063, Germany

Location

Medizinische Universitatsklinik Leipzigerstr. 44

Magdeburg, 39120, Germany

Location

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

Mannheim, 68135, Germany

Location

Deutsches Herzzentrum Minchen Lazarettstr. 36

München, 80636, Germany

Location

Klinikum Grobhadern Universitat Munchen Marchioninistr. 15

München, 81377, Germany

Location

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

Nuremberg, 90471, Germany

Location

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

Tübingen, 72076, Germany

Location

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

Wuppertal, 42117, Germany

Location

Istituto di Malattie cardiovasolari policlinico di bari piazza G Cesare 11

Bari, 70120, Italy

Location

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

Novara, 28100, Italy

Location

Policlinico Matteo Dippartimento di cardiologia Pizza Golgi, 2

Pavia, 27100, Italy

Location

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

Roma, 168, Italy

Location

Academisch Medisch Centrum Amsterdam Afd. Cardiologie Meibergdreef 9

Amsterdam, 1105AZ, Netherlands

Location

Catharina Ziekenhuis Afd. Cardiologie Postbus 1350

Eldhoven, 5602ZA, Netherlands

Location

Academisch Ziekenhuis Groningen Thoraxcentrum Hanzeplein 1

Groningen, 9713GZ, Netherlands

Location

Leids Universitair Medisch Centrum Afd. Cardiologie Postbus 9600

Leiden, 2300 RC, Netherlands

Location

SintAntonius Ziekenhuis Afd R&D Cardiologie Koekoekslaan 1

Nieuwegein, 3435CM, Netherlands

Location

ll Klinika Chorob Serca Akademii Medycznej w Gdansku Kieturakisa 1

Gdansk, 80742, Poland

Location

1 Klinka kardiologii Slaska Akademia Medyczna, Ziolowa 47

Katowice, 40 635, Poland

Location

Oddzial kardiologii-Instut kardiologii, Ul Powstancow

Szczecin, 70111, Poland

Location

Instytut Kardiologii Klinika Choroby Wiencowej,ul Spartanka 1

Warsaw, 02637, Poland

Location

Instytut Kardiologii-Klinka Kardiologii Ogolnej, ul. Alpejska 42

Warsaw, 04628, Poland

Location

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

Barcelona, 8036, Spain

Location

Clinica Puerta de Hierro, San Martin de Porres, 4

Madrid, 28035, Spain

Location

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

Madrid, 28041, Spain

Location

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

Málaga, 29010, Spain

Location

Hospital Clinico Universitario de Valencia, Avenida Blasco Ibanez, 17

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Interventions

azimilide

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jose M Brum, MD

  Procter and Gamble

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 3, 2002
• First Posted: May 6, 2002
• Study Start: September 1, 2001
• Primary Completion: April 1, 2004
• Study Completion: April 1, 2004
• Last Updated: October 3, 2011

Record last verified: 2011-09

Locations

PL (5); FR (9); BE (2); NL (5); US (78); ES (5); DE (23); CA (11); IT (4)