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)



Status:Completed
Conditions:Peripheral Vascular Disease, Cardiology, Hospital
Therapuetic Areas:Cardiology / Vascular Diseases, Other
Healthy:No
Age Range:18 - Any
Updated:3/30/2013
Start Date:November 2011
End Date:August 2014
Contact:Sandra Beaird, PhD
Email:FRXClinTrials@frx.com
Phone:1-800-678-1605

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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


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)


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
We found this trial at
117
sites
Baton Rouge, Louisiana 70808
802
mi
from 43215
Baton Rouge, LA
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Albany, New York 12205
515
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Albany, NY
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Albany, New York 12211
515
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Albany, NY
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Albuquerque, New Mexico 87102
1333
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Albuquerque, NM
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Auburn, Maine 04210
714
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Auburn, ME
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Augusta, Georgia 30901
451
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Augusta, GA
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Austin, Texas 78705
1065
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Austin, TX
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Austin, Texas 78756
1063
mi
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Austin, TX
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Baltimore, Maryland 21237
344
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Baltimore, MD
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Baltimore, Maryland 21201
344
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Baltimore, MD
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Beaver, Pennsylvania 15009
151
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Beaver, PA
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Birmingham, Alabama 35211
492
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Birmingham, AL
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Bloomington, Indiana 47402
194
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Bloomington, IN
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Boise, Idaho 83712
1715
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Boise, ID
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Boston, Massachusetts 02115
643
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Boston, MA
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Boston, Massachusetts 02215
643
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Boston, MA
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Bridgeport, Connecticut 06610
522
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Bridgeport, CT
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Brighton, Massachusetts 02135
638
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Brighton, MA
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Brooklyn, New York 11215
480
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Brooklyn, NY
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Brooklyn, New York 11212
480
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Brooklyn, NY
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Camp Hill, Pennsylvania 17011
322
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Camp Hill, PA
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Canton, Ohio 44708
104
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Canton, OH
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Charleston, South Carolina 29425
525
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Charleston, SC
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Charleston, South Carolina 29407
522
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Chesapeake, Virginia 23320
430
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Chesapeake, VA
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Chicago, Illinois 60611
274
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Chicago, IL
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Chicago, Illinois 60640
279
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Chicago, IL
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Cincinnati, Ohio 45219
98
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Cincinnati, OH
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Cincinnati, Ohio 45242
98
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Cincinnati, OH
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Colorado Springs, Colorado 80909
1161
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Colorado Springs, CO
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Colorado Springs, Colorado 80907
1163
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Colorado Springs, CO
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Columbia, South Carolina 29204
426
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Columbia, SC
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Columbus, Ohio 43214
1
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Columbus, OH
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Crestview Hills, Kentucky 41017
105
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Crestview Hills, KY
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Dallas, Texas 75390
911
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Dallas, TX
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Dallas, Texas 75231
905
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Dallas, TX
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Dayton, Ohio 45417
66
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Dayton, OH
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Englewood,, New Jersey 07631
479
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Englewood,, NJ
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Erie, Pennsylvania 16507
213
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Erie, PA
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Erie, Pennsylvania 16502
213
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Erie, PA
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Fairfield, Ohio 45014
92
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Fairfield, OH
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Falls Church, Virginia 22042
320
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Falls Church, VA
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Flint, Michigan 48532
213
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Flint, MI
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Fort Lauderdale, Florida 33306
968
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Fort Lauderdale, FL
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Fort Worth, Texas 76104
937
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Ft. Lauderdale, Florida 33308
966
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Glendale, California 91206
1969
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Glendale, CA
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Green Bay, Wisconsin 54301
404
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Green Bay, WI
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Greensboro, North Carolina 27401
321
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Greenville, South Carolina 29607
355
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Greenville, SC
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Hershey, Pennsylvania 17033
337
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Hershey, PA
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Hickory, North Carolina 28601
304
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Hollywood, Florida 33021
978
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Hollywood, FL
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Houma, Louisiana 70360
838
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Houston, Texas 77074
1000
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Houston, Texas 77094
991
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Huntsville, Alabama 35801
411
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Indianapolis, Indiana 46237
166
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Jacksonville, Florida 32204
670
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Jacksonville, Florida 32224
670
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Jerseyville, Illinois 62052
393
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Kettering, Ohio 45429
63
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Kissimmee, Florida 34741
810
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La Jolla, California 92093
1953
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Lanham, Maryland 20706
335
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Lansing, Michigan 48910
207
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Lincoln, Nebraska 68506
721
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Littleton, Colorado 80712
1164
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Los Angeles, California 99048
1972
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Louiseville, Kentucky 40202
188
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Lynchburg, Virginia 24501
273
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Madison, Wisconsin 53715
392
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Milwaukee, Wisconsin 53215
330
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Minneapolis, Minnesota 55455
625
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New York, New York 10032
477
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New York, New York 10021
477
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New York, New York 10023
477
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Newark, Delaware 19718
385
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Newport News, Virginia 23601
405
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Norfolk, Virginia 23510
423
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North Miami, Florida 33161
985
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North Miami Beach, Florida 33179
983
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Oklahoma City, Oklahoma 73120
849
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Omaha, Nebraska 68114
682
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Overland Park, Kansas 66209
624
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Philadelphia, Pennsylvania 19102
416
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Philadelphia, Pennsylvania 19141
416
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Phoenix, Arizona 85013
1662
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Port Charlotte, Florida 33952
898
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Providence, Rhode Island 02903
619
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Rapid City, South Dakota 57701
1072
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Richmond, Virginia 23219
344
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Ridgewood, New Jersey 07450
473
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Ridgewood, NJ
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Roanoke, Virginia 24104
249
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Roanoke, VA
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Rockledge, Florida 32955
814
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Rockledge, FL
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Saginaw, Michigan 48601
246
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Saginaw, MI
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San Diego, California 92123
1947
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San Diego, California 92103
1951
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San Diego, CA
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Silver Spring, Maryland 20903
326
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Sioux Falls, South Dakota 57108
747
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South Bend, Indiana 46601
206
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South Bend, IN
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