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

Primary Purpose

Arrhythmia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Azimilide Dihydrochloride
placebo
Azimilide Dihydrochloride
Sponsored by
Forest Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arrhythmia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Heart Group
  • Tri-City Cardiology Consultants, P.C.
  • UAMS Dept of Cardiology
  • ATC/Cardio Medical Grp
  • Loma Linda Univ. Med. Ctr.
  • Good Samaritan Hospital
  • VA Greater Los Angeles Healthcare System
  • Regional Cardiology Associates
  • Cardiac Arrythmia Associates
  • UCSD Medical Center
  • Memorial Hospital
  • Bridgeport Hospital
  • Washington Hospital Center
  • Southwest Florida Health Group
  • Florida Arrythmia Consultants
  • Jacksonville Heart Center
  • The Watson Clinic, LLP
  • Univ. Miami Jackson Mem. med. Ctr.
  • Florida Heart Institute
  • Memorial Health Systems/Cardiology Research Associates
  • Loyola University Med. Ctr.
  • University of Iowa Hospital
  • Mid-America Cardiology c/o KU medical Ctr
  • University Cardiology
  • Louisville Cardiology Medical Group, PSC
  • LSU Health Sciences Center
  • Maine Cardiology Assoc.
  • Mid-Atlantic Cardiovascular Associates
  • St Elizabeth Medical Center
  • Lahey Hitchcock Medical Ctr.
  • Baystate Medical Center-Cardiology Research
  • University of Mass. Medical Ctr. Division of Cardiovascular Medicine
  • SMDC Education Research
  • University of Minnesota-Cardiology
  • Nevada Cardiology
  • Morristown Memorial Hospital
  • Atlantic Health Systems
  • Arrhythmia and Pacemaker Consultants
  • Brookdale University Hospital
  • Huntington Hospital
  • Cardiology Assoc., PC
  • St. Lukes/Roosevelt Hospital Center
  • The Mt Sinai Medical Ctr.
  • Rochester Cardiopulmonary Group
  • University of Rochester Strong mem. Hospital
  • Buffalo Cardiology & Pulmonary Assoc.
  • Mid Carolina Cardiology
  • Duke University Medical Ctr.
  • Wake Forest School of Medicine
  • United HealthNetwork/Ohio Heart Center
  • The Lindnar Clinical Trial Center
  • University Hospitals of Cleveland
  • Cleveland Clinic Foundation
  • Midwest Cardio Res. Foundation
  • Dayton Cardiac EP
  • Medical College of Ohio
  • Oklahoma Heart Institute
  • Cardiovascular Assoc.
  • Doylestown Medical Hospital
  • Hershey Med. Ctr.-Div. Cardiology
  • Lancaster Heart Foundation
  • Univ of PA/Presbyterian Hospital
  • Thomas Jefferson University
  • Barry Alpert, MD, FACC
  • Blackstone Cardiology Assoc. P.C.
  • Medical University of South Carolina
  • South Carolina Heart Center
  • Mid-State Cardiology
  • Heart Place/Baylor University of Medicine
  • UT Southwestern Medical Center at Dallas
  • Baylor College of Medicine
  • University of Utah Medical Ctr.
  • U. OF Virginia/Dept of Cardiology
  • The Cardiovascular Grp./Attn: Mandy Murphy
  • Medical College of VA
  • Inland Cardiology/The Heart Inst.
  • Cardiology Associates of Green Bay
  • Wisconsin Ctr for Clinical Research
  • A.Z. Sint-Jan, Ruddershove, 10
  • Clin. Univ. UCL de Mont-Godinne-
  • University of Alberta Hospital
  • Cardiac Arrythmia Trials/Royal Jubilee Hosp.
  • Academisch ZiekenhuisRotterdam, Thoraxentrum Dr. Molewaterplein 40
  • Health Sciences Ctr
  • Isala Klinieken Loc Weezenlanden Afd. Cardiologie Groot Wezenland 20
  • QE II Health Sciences Ctr.
  • Hamilton General Hospital/McMaster Clinic
  • St Michaels Hospital 30 Bond Street 7-050 Queen
  • Montreal Heart Institute
  • Laval Hospital
  • Winnepeg Health Science Ctr.
  • CHRU de Lille-Hopital Cardiologique-Bd du Pr Leclerc
  • Centre hospitalier L. Pradel-28 av. du doyen Lepine
  • Hopital Nord-Chemin Bourrely St Antoine
  • CHRU de Nancy-29 av. de Lattre de Tassigny
  • CHRU de Nantes-Hopital G. et R. Laennec-bd Jacques Monod
  • Hopital Lariboisiere-2 rue A. Pare
  • Hopital cardiologique du Haut Leveque-av. de Magellan
  • CHRU de Rennes-Hotel Dieu-2 rue l'hotel Dieu
  • CHRU de TOURS-Hopital TROUSSEAU-Chanbray les Tours
  • Herz-kreislauf-Klinik Bevensen AG Kardiologie Akut Romstedter Str. 25
  • Kerckhoff Klinik Abteilung Elektrophysiologie Benekestr. 2
  • Herzzentrum NRW Kardiologische Ambulanz Georgstr. 11
  • Krankenhaus Am Urban Innere Medizin I (Kardiologie) Dieffenbachstr. 1
  • Charite Campus Buch Franz-Vollhard-Klinik Wiltbergstr. 50
  • Virchow-Klinikum Franz-Volhard-Klinik Wiltbergstr. 50
  • Universitatsklinikum Bonn Medizinische Klinik und Poliklinik II Sigmund-Freud-Str. 25
  • Stadtisches Klinikum Brandenburg Medizinische Klinik I Kardiologie Hochstr. 29
  • Klinikum Coburg Ketschendorferstr. 33
  • Evangelische Krankenhaus Abteilung Kardiologie Kirchfeldstr. 40
  • Universitatsklinikum Dusseldorf Klinik fur Kardiologie Moorenstr. 5
  • Klinikum der Johann-Wolfgang-Goethe-Universitat Medizinische Klinik IV Abteilung Elektrophysiologie Theodor-Stern-Kai 7
  • Medizinische Universitatsklinik
  • Universitats-Krankenhaus Eppendorf Abteilung Kardiologie Martinistr. 52
  • Medizinische Universitats Klinik Heidelberg Medisin III (Kardiologie) Bergheimerstr. 58
  • Klinikum der Stadt Ludwigshafen Bremserstr. 79
  • Medizinische Universitatsklinik Leipzigerstr. 44
  • Universitatsklinikum I. Medizinische Klinik Kardiologie/Angiologie/Pneumologie Theodor-Kutzer-Ufer 1-3
  • Deutsches Herzzentrum Minchen Lazarettstr. 36
  • Klinikum Grobhadern Universitat Munchen Marchioninistr. 15
  • Stadt. Klinikum Nurnberg-Sud Med. Klinik 8-Kardiologie Kardiologie KH II/8
  • Medizinische Klinik und Poliklinik Universitat Tubingen Ottfried-Muller-Str. 10
  • Klinikum Wuppwrtal GmbH Klinik Fur Herz-und Thoraxchirugie Arrenbergerstr. 20
  • Istituto di Malattie cardiovasolari policlinico di bari piazza G Cesare 11
  • Ospedale Maggiore della carita II Divisione di cardiologia, corso mazzini 18
  • Policlinico Matteo Dippartimento di cardiologia Pizza Golgi, 2
  • Divisione di cardiologia Ospedale s. Flippo Neri, Via Martinotti 20
  • Academisch Medisch Centrum Amsterdam Afd. Cardiologie Meibergdreef 9
  • Catharina Ziekenhuis Afd. Cardiologie Postbus 1350
  • Academisch Ziekenhuis Groningen Thoraxcentrum Hanzeplein 1
  • Leids Universitair Medisch Centrum Afd. Cardiologie Postbus 9600
  • SintAntonius Ziekenhuis Afd R&D Cardiologie Koekoekslaan 1
  • ll Klinika Chorob Serca Akademii Medycznej w Gdansku Kieturakisa 1
  • 1 Klinka kardiologii Slaska Akademia Medyczna, Ziolowa 47
  • Oddzial kardiologii-Instut kardiologii, Ul Powstancow
  • Instytut Kardiologii Klinika Choroby Wiencowej,ul Spartanka 1
  • Instytut Kardiologii-Klinka Kardiologii Ogolnej, ul. Alpejska 42
  • Hospital Clinic i Provincial, Servicio de Cardiologia, Villarroel, 170
  • Clinica Puerta de Hierro, San Martin de Porres, 4
  • Hospital 12 de Octubre, Carretera de Andalucia, km. 5, 4
  • Hospital Virgen de la Victoria, Campus Universitario de Teatinos, s/n
  • Hospital Clinico Universitario de Valencia, Avenida Blasco Ibanez, 17

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

1

2

3

Arm Description

Placebo tablets

75 mg azimilide

125 mg azimilide

Outcomes

Primary Outcome Measures

Reducing the recurrence of all-cause shocks plus symptomatic ATP

Secondary Outcome Measures

Full Information

First Posted
May 3, 2002
Last Updated
September 30, 2011
Sponsor
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00035490
Brief Title
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

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
April 2004 (Actual)
Study Completion Date
April 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Forest Laboratories

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
633 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Placebo tablets
Arm Title
2
Arm Type
Experimental
Arm Description
75 mg azimilide
Arm Title
3
Arm Type
Experimental
Arm Description
125 mg azimilide
Intervention Type
Drug
Intervention Name(s)
Azimilide Dihydrochloride
Intervention Description
125 mg azimilide, once a day for one year
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo tablet, once daily for one year
Intervention Type
Drug
Intervention Name(s)
Azimilide Dihydrochloride
Intervention Description
75 mg azimilide, once a day for one year
Primary Outcome Measure Information:
Title
Reducing the recurrence of all-cause shocks plus symptomatic ATP
Time Frame
one year

10. Eligibility

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

12. IPD Sharing Statement

Learn more about this trial

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

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