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Efficacy and Safety Study of Azimilide on the Incidence of Cardiovascular Hospitalizations/Emergency Department Visits or Cardiovascular Death in Patients With an Implantable Cardioverter Defibrillator (ICD) (SHIELD-2) (SHIELD-2)

Primary Purpose

Arrhythmias, Cardiac, Heart Diseases, Cardiovascular Diseases

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

About this trial

This is an interventional treatment trial for Arrhythmias, Cardiac

Eligibility Criteria

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

Inclusion Criteria:

  • Have an ICD implanted and a history of ventricular tachycardia, ventricular fibrillation, or an appropriate ICD therapy.
  • Have a left ventricular ejection fraction <= 0.40

Exclusion Criteria:

  • Have New York Heart Association (NYHA) Class IV Congestive Heart Failure (CHF) or have decompensated CHF at the time of randomization;
  • Have unstable angina pectoris or a myocardial infarction within 30 days of randomization;
  • Have a history of Torsade de Pointes or heart transplantation
  • Have chronic atrial fibrillation or atrial fibrillation/flutter, that is not adequately rate controlled in the judgment of the Investigator, at screening;
  • Are currently taking systemic Class I or other Class III antiarrhythmic drugs
  • Are currently taking systemic drugs that prolong the QT interval
  • If female, are currently pregnant or breast feeding, or plan to become pregnant during the course of the study

Sites / Locations

  • Forest Investigative Site 053
  • Forest Investigative Site 048
  • Forest Investigative Site 013
  • Forest Investigative Site 110
  • Forest Investigative Site 022
  • Forest Investigative Site 060
  • Forest Investigative Site 090
  • Forest Investigative Site 041
  • Forest Investigative Site 113
  • Forest Investigative Site 010
  • Forest Investigative Site 035
  • Forest Investigative Site 044
  • Forest Investigative Site 062
  • Forest Investigative Site 082
  • Forest Investigative Site 006
  • Forest Investigative Site 123
  • Forest Investigative Site 092
  • Forest Investigative Site 012
  • Forest Investigative Site 068
  • Forest Investigative Site 087
  • Forest Investigative Site 063
  • Forest Investigative Site 050
  • Forest Investigative Site 030
  • Forest Investigative Site 058
  • Forest Investigative Site 052
  • Forest Investigative Site 118
  • Forest Investigative Site 015
  • Forest Investigative Site 091
  • Forest Investigative Site 020
  • Forest Investigative Site 085
  • Forest Investigative Site 079
  • Forest Investigative Site 034
  • Forest Investigative Site 121
  • Forest Investigative Site 088
  • Forest Investigative Site 100
  • Forest Investigative Site 055
  • Forest Investigative Site 059
  • Forest Investigative Site 106
  • Forest Investigative Site 112
  • Forest Investigative Site 018
  • Forest Investigative Site 069
  • Forest Investigative Site 045
  • Forest Investigative Site 122
  • Forest Investigative Site 075
  • Forest Investigative Site 089
  • Forest Investigative Site 116
  • Forest Investigative Site 070
  • Forest Investigative Site 064
  • Forest Investigative Site 124
  • Forest Investigative Site 043
  • Forest Investigative Site 083
  • Forest Investigative Site 109
  • Forest Investigative Site 119
  • Forest Investigative Site 003
  • Forest Investigative Site 056
  • Forest Investigative Site 081
  • Forest Investigative Site 008
  • Forest Investigative Site 024
  • Forest Investigative Site 095
  • Forest Investigative Site 005
  • Forest Investigative Site 107
  • Forest Investigative Site 046
  • Forest Investigative Site 084
  • Forest Investigative Site 066
  • Forest Investigative Site 073
  • Forest Investigative Site 014
  • Forest Investigative Site 094
  • Forest Investigative Site 029
  • Forest Investigative Site 028
  • Forest Investigative Site 007
  • Forest Investigative Site 111
  • Forest Investigative Site 125
  • Forest Investigative Site 076
  • Forest Investigative Site 074
  • Forest Investigative Site 016
  • Forest Investigative Site 004
  • Forest Investigative Site 117
  • Forest Investigative Site 065
  • Forest Investigative Site 072
  • Forest Investigative Site 023
  • Forest Investigative Site 071
  • Forest Investigative Site 042
  • Forest Investigative Site 049
  • Forest Investigative Site 302
  • Forest Investigative Site 303
  • Forest Investigative Site 300
  • Forest Investigative Site 304
  • Forest Investigative Site 301
  • Forest Investigative Site 264
  • Forest Investigative Site 269
  • Forest Investigative Site 252
  • Forest Investigative Site 267
  • Forest Investigative Site 253
  • Forest Investigative Site 259
  • Forest Investigative Site 263
  • Forest Investigative Site 254
  • Forest Investigative Site 250
  • Forest Investigative Site 270
  • Forest Investigative Site 262
  • Forest Investigative Site 750
  • Forest Investigative Site 753
  • Forest Investigative Site 751
  • Forest Investigative Site 754
  • Forest Investigative Site 752
  • Forest Investigative Site 852
  • Forest Investigative Site 850
  • Forest Investigative Site 854
  • Forest Investigative Site 853
  • Forest Investigative Site 851
  • Forest Investigative Site 353
  • Forest Investigative Site 354
  • Forest Investigative Site 350
  • Forest Investigative Site 358
  • Forest Investigative Site 357
  • Forest Investigative Site 405
  • Forest Investigative Site 402
  • Forest Investigative Site 410
  • Forest Investigative Site 406
  • Forest Investigative Site 401
  • Forest Investigative Site 450
  • Forest Investigative Site 453
  • Forest Investigative Site 452
  • Forest Investigative Site 451
  • Forest Investigative Site 504
  • Forest Investigative Site 502
  • Forest Investigative Site 552
  • Forest Investigative Site 550
  • Forest Investigative Site 555
  • Forest Investigative Site 706
  • Forest Investigative Site 705
  • Forest Investigative Site 604
  • Forest Investigative Site 601
  • Forest Investigative Site 800
  • Forest Investigative Site 805
  • Forest Investigative Site 804
  • Forest Investigative Site 802
  • Forest Investigative Site 801
  • Forest Investigative Site 803

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Azimilide

Placebo

Arm Description

Azimilide 75 mg film coated tablets

Outcomes

Primary Outcome Measures

Time to first cardiovascular event
Time to first unplanned cardiovascular hospitalization, unplanned cardiovascular emergency department visit, or cardiovascular death in patients with an Implantable Cardioverter Defibrillator (ICD)

Secondary Outcome Measures

Time to first all-cause shock by the ICD
Time to first all-cause shock initiated by the Implantable Cardioverter Defibrillator
Time to first unplanned physician-office visit.
Time to the first unplanned physician-office visit.

Full Information

First Posted
November 1, 2011
Last Updated
May 2, 2013
Sponsor
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT01464476
Brief Title
Efficacy and Safety Study of Azimilide on the Incidence of Cardiovascular Hospitalizations/Emergency Department Visits or Cardiovascular Death in Patients With an Implantable Cardioverter Defibrillator (ICD) (SHIELD-2)
Acronym
SHIELD-2
Official Title
Phase 3 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Effects of Once Daily Oral Doses of 75 mg Azimilide Dihydrochloride on the Incidence of Cardiovascular Hospitalizations/Emergency Department Visits or Cardiovascular Death in Patients With an Implantable Cardioverter Defibrillator
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Terminated
Study Start Date
November 2011 (undefined)
Primary Completion Date
May 2013 (Anticipated)
Study Completion Date
June 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Forest Laboratories

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will evaluate the efficacy and safety of Azimilide on the incidence of cardiovascular hospitalizations, cardiovascular emergency department visits or cardiovascular death in patients with Implantable Cardioverter Defibrillators (ICDs)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmias, Cardiac, Heart Diseases, Cardiovascular Diseases, Implantable Cardioverter Defibrillator

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Azimilide
Arm Type
Experimental
Arm Description
Azimilide 75 mg film coated tablets
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Azimilide Dihydrochloride
Intervention Description
Azimilide 75 mg. Once daily, oral administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Dose-matched placebo. Once daily, oral administration
Primary Outcome Measure Information:
Title
Time to first cardiovascular event
Description
Time to first unplanned cardiovascular hospitalization, unplanned cardiovascular emergency department visit, or cardiovascular death in patients with an Implantable Cardioverter Defibrillator (ICD)
Time Frame
365 days
Secondary Outcome Measure Information:
Title
Time to first all-cause shock by the ICD
Description
Time to first all-cause shock initiated by the Implantable Cardioverter Defibrillator
Time Frame
365 days
Title
Time to first unplanned physician-office visit.
Description
Time to the first unplanned physician-office visit.
Time Frame
365 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have an ICD implanted and a history of ventricular tachycardia, ventricular fibrillation, or an appropriate ICD therapy. Have a left ventricular ejection fraction <= 0.40 Exclusion Criteria: Have New York Heart Association (NYHA) Class IV Congestive Heart Failure (CHF) or have decompensated CHF at the time of randomization; Have unstable angina pectoris or a myocardial infarction within 30 days of randomization; Have a history of Torsade de Pointes or heart transplantation Have chronic atrial fibrillation or atrial fibrillation/flutter, that is not adequately rate controlled in the judgment of the Investigator, at screening; Are currently taking systemic Class I or other Class III antiarrhythmic drugs Are currently taking systemic drugs that prolong the QT interval If female, are currently pregnant or breast feeding, or plan to become pregnant during the course of the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David B Bharucha, MD, PhD
Organizational Affiliation
Forest Laboratories
Official's Role
Study Director
Facility Information:
Facility Name
Forest Investigative Site 053
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35211
Country
United States
Facility Name
Forest Investigative Site 048
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Forest Investigative Site 013
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Forest Investigative Site 110
City
Los Angeles
State/Province
California
ZIP/Postal Code
99048
Country
United States
Facility Name
Forest Investigative Site 022
City
Merced
State/Province
California
ZIP/Postal Code
95340
Country
United States
Facility Name
Forest Investigative Site 060
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Forest Investigative Site 090
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80712
Country
United States
Facility Name
Forest Investigative Site 041
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
Forest Investigative Site 113
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Forest Investigative Site 010
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Forest Investigative Site 035
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Forest Investigative Site 044
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
Forest Investigative Site 062
City
Rockledge
State/Province
Florida
ZIP/Postal Code
32955
Country
United States
Facility Name
Forest Investigative Site 082
City
Safety Harbor
State/Province
Florida
ZIP/Postal Code
34695
Country
United States
Facility Name
Forest Investigative Site 006
City
Zephyrhills
State/Province
Florida
ZIP/Postal Code
33542
Country
United States
Facility Name
Forest Investigative Site 123
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30901
Country
United States
Facility Name
Forest Investigative Site 092
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
Forest Investigative Site 012
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47402
Country
United States
Facility Name
Forest Investigative Site 068
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
Forest Investigative Site 087
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Forest Investigative Site 063
City
Houma
State/Province
Louisiana
ZIP/Postal Code
70360
Country
United States
Facility Name
Forest Investigative Site 050
City
Auburn
State/Province
Maine
ZIP/Postal Code
04210
Country
United States
Facility Name
Forest Investigative Site 030
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Forest Investigative Site 058
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Forest Investigative Site 052
City
Lanham
State/Province
Maryland
ZIP/Postal Code
20706
Country
United States
Facility Name
Forest Investigative Site 118
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20903
Country
United States
Facility Name
Forest Investigative Site 015
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Forest Investigative Site 091
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Forest Investigative Site 020
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48601
Country
United States
Facility Name
Forest Investigative Site 085
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States
Facility Name
Forest Investigative Site 079
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
Facility Name
Forest Investigative Site 034
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
Forest Investigative Site 121
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
Forest Investigative Site 088
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Forest Investigative Site 100
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63125
Country
United States
Facility Name
Forest Investigative Site 055
City
Englewood,
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
Facility Name
Forest Investigative Site 059
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450
Country
United States
Facility Name
Forest Investigative Site 106
City
Warren
State/Province
New Jersey
ZIP/Postal Code
07059
Country
United States
Facility Name
Forest Investigative Site 112
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Forest Investigative Site 018
City
Albany
State/Province
New York
ZIP/Postal Code
12205
Country
United States
Facility Name
Forest Investigative Site 069
City
Albany
State/Province
New York
ZIP/Postal Code
12211
Country
United States
Facility Name
Forest Investigative Site 045
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Forest Investigative Site 122
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Forest Investigative Site 075
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Forest Investigative Site 089
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Forest Investigative Site 116
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
Forest Investigative Site 070
City
Canton
State/Province
Ohio
ZIP/Postal Code
44708
Country
United States
Facility Name
Forest Investigative Site 064
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Forest Investigative Site 124
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Forest Investigative Site 043
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Forest Investigative Site 083
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Forest Investigative Site 109
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43615
Country
United States
Facility Name
Forest Investigative Site 119
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Forest Investigative Site 003
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Forest Investigative Site 056
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
Facility Name
Forest Investigative Site 081
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16502
Country
United States
Facility Name
Forest Investigative Site 008
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16507
Country
United States
Facility Name
Forest Investigative Site 024
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Forest Investigative Site 095
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
Forest Investigative Site 005
City
Wilkes-Barre
State/Province
Pennsylvania
ZIP/Postal Code
18711
Country
United States
Facility Name
Forest Investigative Site 107
City
Yardley
State/Province
Pennsylvania
ZIP/Postal Code
19067
Country
United States
Facility Name
Forest Investigative Site 046
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17403
Country
United States
Facility Name
Forest Investigative Site 084
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Forest Investigative Site 066
City
Florence
State/Province
South Carolina
ZIP/Postal Code
29501
Country
United States
Facility Name
Forest Investigative Site 073
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
Forest Investigative Site 014
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Forest Investigative Site 094
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57108
Country
United States
Facility Name
Forest Investigative Site 029
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78404
Country
United States
Facility Name
Forest Investigative Site 028
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Forest Investigative Site 007
City
Fort Worth,
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Forest Investigative Site 111
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Forest Investigative Site 125
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Forest Investigative Site 076
City
Houston
State/Province
Texas
ZIP/Postal Code
77094
Country
United States
Facility Name
Forest Investigative Site 074
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Forest Investigative Site 016
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320
Country
United States
Facility Name
Forest Investigative Site 004
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Forest Investigative Site 117
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
Facility Name
Forest Investigative Site 065
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23601
Country
United States
Facility Name
Forest Investigative Site 072
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Facility Name
Forest Investigative Site 023
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24104
Country
United States
Facility Name
Forest Investigative Site 071
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301
Country
United States
Facility Name
Forest Investigative Site 042
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53715
Country
United States
Facility Name
Forest Investigative Site 049
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Forest Investigative Site 302
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Forest Investigative Site 303
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
Forest Investigative Site 300
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Forest Investigative Site 304
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Forest Investigative Site 301
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Forest Investigative Site 264
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H 3V9
Country
Canada
Facility Name
Forest Investigative Site 269
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z1M9
Country
Canada
Facility Name
Forest Investigative Site 252
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 4R2
Country
Canada
Facility Name
Forest Investigative Site 267
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
Forest Investigative Site 253
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L2V7
Country
Canada
Facility Name
Forest Investigative Site 259
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Forest Investigative Site 263
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1N9
Country
Canada
Facility Name
Forest Investigative Site 254
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1T8
Country
Canada
Facility Name
Forest Investigative Site 250
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G1A4
Country
Canada
Facility Name
Forest Investigative Site 270
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Forest Investigative Site 262
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada
Facility Name
Forest Investigative Site 750
City
Brno
ZIP/Postal Code
65691
Country
Czech Republic
Facility Name
Forest Investigative Site 753
City
Ceské Budejovice
ZIP/Postal Code
37001
Country
Czech Republic
Facility Name
Forest Investigative Site 751
City
Olomouc
ZIP/Postal Code
77520
Country
Czech Republic
Facility Name
Forest Investigative Site 754
City
Prague
ZIP/Postal Code
15030
Country
Czech Republic
Facility Name
Forest Investigative Site 752
City
Sokolska
ZIP/Postal Code
0581
Country
Czech Republic
Facility Name
Forest Investigative Site 852
City
Aalborg
ZIP/Postal Code
DK-9100
Country
Denmark
Facility Name
Forest Investigative Site 850
City
Copenhagen
ZIP/Postal Code
DK-2100
Country
Denmark
Facility Name
Forest Investigative Site 854
City
Esbjerg
ZIP/Postal Code
DK6700
Country
Denmark
Facility Name
Forest Investigative Site 853
City
Hellerup
ZIP/Postal Code
DK-2900
Country
Denmark
Facility Name
Forest Investigative Site 851
City
Odense
ZIP/Postal Code
DK-5000
Country
Denmark
Facility Name
Forest Investigative Site 353
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Forest Investigative Site 354
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Forest Investigative Site 350
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Forest Investigative Site 358
City
Nantes
ZIP/Postal Code
44800
Country
France
Facility Name
Forest Investigative Site 357
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Forest Investigative Site 405
City
Berlin
ZIP/Postal Code
14050
Country
Germany
Facility Name
Forest Investigative Site 402
City
Gottingen
ZIP/Postal Code
37099
Country
Germany
Facility Name
Forest Investigative Site 410
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Forest Investigative Site 406
City
Ludwigshafen
ZIP/Postal Code
67063
Country
Germany
Facility Name
Forest Investigative Site 401
City
Mannheim
ZIP/Postal Code
D-68167
Country
Germany
Facility Name
Forest Investigative Site 450
City
Ashkelon
ZIP/Postal Code
78278
Country
Israel
Facility Name
Forest Investigative Site 453
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Forest Investigative Site 452
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Forest Investigative Site 451
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Forest Investigative Site 504
City
Ancona
ZIP/Postal Code
41060
Country
Italy
Facility Name
Forest Investigative Site 502
City
Catania
ZIP/Postal Code
95124
Country
Italy
Facility Name
Forest Investigative Site 552
City
Breda
ZIP/Postal Code
4818 CK
Country
Netherlands
Facility Name
Forest Investigative Site 550
City
Eindhoven
ZIP/Postal Code
5623
Country
Netherlands
Facility Name
Forest Investigative Site 555
City
Zwolle
ZIP/Postal Code
8011 JW
Country
Netherlands
Facility Name
Forest Investigative Site 706
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Forest Investigative Site 705
City
Gdynia
ZIP/Postal Code
81-423
Country
Poland
Facility Name
Forest Investigative Site 604
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Forest Investigative Site 601
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Forest Investigative Site 800
City
Lund
ZIP/Postal Code
22185
Country
Sweden
Facility Name
Forest Investigative Site 805
City
Orebro
ZIP/Postal Code
70185
Country
Sweden
Facility Name
Forest Investigative Site 804
City
Stockholm
ZIP/Postal Code
11883
Country
Sweden
Facility Name
Forest Investigative Site 802
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden
Facility Name
Forest Investigative Site 801
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
Facility Name
Forest Investigative Site 803
City
Vasteras
ZIP/Postal Code
72189
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety Study of Azimilide on the Incidence of Cardiovascular Hospitalizations/Emergency Department Visits or Cardiovascular Death in Patients With an Implantable Cardioverter Defibrillator (ICD) (SHIELD-2)

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