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Long Term Safety of 125 mg Per Day of Oral Azimilide in Patients With Implantable Cardioverter Defibrillator (ICDs)

Primary Purpose

Arrhythmias

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

About this trial

This is an interventional treatment trial for Arrhythmias

Eligibility Criteria

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

Inclusion Criteria:

  • patients who completed at least 12 months on study 2000098 before inclusion in this study

Exclusion Criteria:

  • breast feeding or plan to become pregnant
  • used ticlopidine
  • were taking Class I or other Class III drugs

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Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

125 mg azimilide

Outcomes

Primary Outcome Measures

safety of azimilide in this patient population

Secondary Outcome Measures

Full Information

First Posted
September 11, 2008
Last Updated
January 31, 2017
Sponsor
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00751738
Brief Title
Long Term Safety of 125 mg Per Day of Oral Azimilide in Patients With Implantable Cardioverter Defibrillator (ICDs)
Official Title
A Multi-center, Open-label, Follow-up Study to Assess the Long-term Safety of 125 mg Per Day of Oral Azimilide Dihydrochloride in Patients With an Implantable Cardioverter Defibrillator
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
October 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Forest Laboratories

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is an open-label, multi-center, long-term, (open-ended) safety study with 125 mg per day of azimilide in patients who completed protocol 2000098.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
330 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
125 mg azimilide
Intervention Type
Drug
Intervention Name(s)
azimilide dihydrochloride
Intervention Description
oral, once daily until sponsor stopped the study
Primary Outcome Measure Information:
Title
safety of azimilide in this patient population
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients who completed at least 12 months on study 2000098 before inclusion in this study Exclusion Criteria: breast feeding or plan to become pregnant used ticlopidine were taking Class I or other Class III drugs
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
Research Facility
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
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United States
Facility Name
Research Facility
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
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United States
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Research Facility
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LaJolla
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California
ZIP/Postal Code
92037
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United States
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Research Facility
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Loma Linda
State/Province
California
ZIP/Postal Code
932354
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United States
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Research Facility
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Sacramento
State/Province
California
ZIP/Postal Code
95819
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United States
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Research Facility
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Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80910
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United States
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Research Facility
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Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06610
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United States
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Research Facility
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Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
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United States
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Research Facility
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Ft. Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
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United States
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Research Facility
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Ft. Myers
State/Province
Florida
ZIP/Postal Code
33919
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United States
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Research Facility
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Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
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United States
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Research Facility
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Maywood
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Illinois
ZIP/Postal Code
60153
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United States
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Research Facility
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Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
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United States
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Research Facility
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Portland
State/Province
Maine
ZIP/Postal Code
04102
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United States
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Research Facility
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Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
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United States
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Research Facility
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Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
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United States
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Boston
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Massachusetts
ZIP/Postal Code
02135
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United States
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Burlington
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Massachusetts
ZIP/Postal Code
01805
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United States
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Research Facility
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Worcester
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Massachusetts
ZIP/Postal Code
01655
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United States
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Warren
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New Jersey
ZIP/Postal Code
07059
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United States
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Brooklyn
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New York
ZIP/Postal Code
11212
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United States
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Johnson City
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New York
ZIP/Postal Code
13797
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United States
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New York
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New York
ZIP/Postal Code
10025
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United States
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New York
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New York
ZIP/Postal Code
10029
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United States
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Rochester
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New York
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14621
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United States
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Rochester
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New York
ZIP/Postal Code
14642
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United States
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West Orange
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New York
ZIP/Postal Code
07052
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United States
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Williamsville
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New York
ZIP/Postal Code
14221
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United States
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Durham
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North Carolina
ZIP/Postal Code
27710
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United States
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Winston-Salem
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North Carolina
ZIP/Postal Code
27157
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United States
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Cincinnati
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Ohio
ZIP/Postal Code
45219
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United States
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Toledo
State/Province
Ohio
ZIP/Postal Code
43614
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United States
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Tulsa
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Oklahoma
ZIP/Postal Code
74104
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United States
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Erie
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Pennsylvania
ZIP/Postal Code
16502
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United States
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Hershey
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Pennsylvania
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17033
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United States
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Lancaster
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Pennsylvania
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17603
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United States
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Philadelphia
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Pennsylvania
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19104
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United States
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Charleston
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South Carolina
ZIP/Postal Code
29425
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United States
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Columbia
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South Carolina
ZIP/Postal Code
29204
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United States
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Germantown
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Tennessee
ZIP/Postal Code
38138
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United States
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Nashville
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Tennessee
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37203
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United States
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Dallas
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Texas
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75226
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United States
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Dallas
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Texas
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75390
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United States
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Houston
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Texas
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77030
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United States
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Salt Lake City
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Utah
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84132
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United States
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Charlottesville
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Virginia
ZIP/Postal Code
22908
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United States
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Fairfax
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Virginia
ZIP/Postal Code
22031
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United States
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Spokane
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Washington
ZIP/Postal Code
99204
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United States
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Green Bay
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Wisconsin
ZIP/Postal Code
54301
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United States
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Milwaukee
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Wisconsin
ZIP/Postal Code
53215
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United States
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Brugge
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Belgium
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Mont Godinne
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Belgium
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Victoria
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British Columbia
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Canada
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St. Johns
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Newfoundland and Labrador
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Canada
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Halifax
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Nova Scotia
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Canada
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Hamilton
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Ontario
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Canada
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Ottawa
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Ontario
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Canada
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Toronto
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Ontario
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Canada
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Montreal
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Quebec
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Canada
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Quebec
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Canada
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Lille Cedex
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France
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Nantes Cedex
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France
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Paris Cedex
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France
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Pessac Cedex
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France
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Tours Cedex
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France
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Bad Bevensen
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Germany
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Berlin
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Germany
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Brandenburg an der Havel
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Germany
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Coburg
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Germany
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Frankfurt
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Germany
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Freiburg
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Germany
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Hamburg
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Germany
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Heidelberg
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Germany
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Ludwigshafen
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Germany
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Magdeburg
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Germany
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Mannheim
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Germany
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Tubingen
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Germany
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Gdansk
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Poland
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Katowice
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Poland
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Lublin
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Poland
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Szczecin
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Poland
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Warszawa
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Poland
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Barcelona
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Spain
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Madrid
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Spain
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Malaga
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Spain
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City
Valencia
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

Long Term Safety of 125 mg Per Day of Oral Azimilide in Patients With Implantable Cardioverter Defibrillator (ICDs)

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