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
New York, New York 10021
1286
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New York, NY
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Albany, New York 12205
1309
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Albany, NY
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Albany, New York 12211
1309
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Albuquerque, New Mexico 87102
523
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Albuquerque, NM
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Auburn, Maine 04210
1497
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Auburn, ME
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Augusta, Georgia 30901
936
mi
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Augusta, GA
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Austin, Texas 78705
517
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Austin, TX
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Austin, Texas 78756
513
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Austin, TX
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Baltimore, Maryland 21237
1148
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Baltimore, MD
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Baltimore, Maryland 21201
1148
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Baton Rouge, Louisiana 70808
631
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Baton Rouge, LA
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Beaver, Pennsylvania 15009
957
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Beaver, PA
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Birmingham, Alabama 35211
683
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Birmingham, AL
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Bloomington, Indiana 47402
618
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Bloomington, IN
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Boise, Idaho 83712
1041
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Boise, ID
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Boston, Massachusetts 02115
1444
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Boston, MA
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Boston, Massachusetts 02215
1444
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Boston, MA
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Bridgeport, Connecticut 06610
1330
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Brighton, Massachusetts 02135
1439
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Brighton, MA
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Brooklyn, New York 11215
1290
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Brooklyn, New York 11212
1290
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Camp Hill, Pennsylvania 17011
1132
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Camp Hill, PA
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Canton, Ohio 44708
903
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Canton, OH
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Charleston, South Carolina 29425
1063
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Charleston, SC
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Charleston, South Carolina 29407
1059
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Charleston, SC
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Chesapeake, Virginia 23320
1186
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Chesapeake, VA
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Chicago, Illinois 60611
611
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Chicago, IL
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Chicago, Illinois 60640
611
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Chicago, IL
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Cincinnati, Ohio 45219
725
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Cincinnati, OH
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Cincinnati, Ohio 45242
726
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Colorado Springs, Colorado 80909
384
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Colorado Springs, CO
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Colorado Springs, Colorado 80907
386
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Columbia, South Carolina 29204
972
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Columbia, SC
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Columbus, Ohio 43214
810
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Crestview Hills, Kentucky 41017
722
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Crestview Hills, KY
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Dallas, Texas 75390
348
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Dallas, TX
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Dallas, Texas 75231
342
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Dallas, TX
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Dayton, Ohio 45417
743
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Dayton, OH
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Englewood,, New Jersey 07631
1288
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Englewood,, NJ
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Erie, Pennsylvania 16507
984
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Erie, PA
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Erie, Pennsylvania 16502
984
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Fairfield, Ohio 45014
724
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Falls Church, Virginia 22042
1119
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Flint, Michigan 48532
821
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Fort Lauderdale, Florida 33306
1306
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Fort Worth, Texas 76104
346
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Ft. Lauderdale, Florida 33308
1305
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Glendale, California 91206
1166
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Green Bay, Wisconsin 54301
691
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Green Bay, WI
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Greensboro, North Carolina 27401
1001
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Greenville, South Carolina 29607
880
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Hershey, Pennsylvania 17033
1147
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Hershey, PA
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Hickory, North Carolina 28601
921
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Hollywood, Florida 33021
1311
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Hollywood, FL
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Houma, Louisiana 70360
695
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Houston, Texas 77074
572
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Houston, Texas 77094
569
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Huntsville, Alabama 35801
659
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Indianapolis, Indiana 46237
643
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Jacksonville, Florida 32204
1055
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Jacksonville, Florida 32224
1055
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Jerseyville, Illinois 62052
416
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Kettering, Ohio 45429
747
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Kissimmee, Florida 34741
1149
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La Jolla, California 92093
1145
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Lanham, Maryland 20706
1136
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Lansing, Michigan 48910
776
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Lincoln, Nebraska 68506
219
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Littleton, Colorado 80712
408
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Los Angeles, California 99048
1168
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Louiseville, Kentucky 40202
656
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Lynchburg, Virginia 24501
1021
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Madison, Wisconsin 53715
575
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Milwaukee, Wisconsin 53215
636
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Minneapolis, Minnesota 55455
552
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New York, New York 10032
1286
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New York, New York 10023
1286
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Newark, Delaware 19718
1193
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Newport News, Virginia 23601
1169
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Norfolk, Virginia 23510
1182
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North Miami, Florida 33161
1316
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North Miami Beach, Florida 33179
1315
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Oklahoma City, Oklahoma 73120
158
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Omaha, Nebraska 68114
262
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Overland Park, Kansas 66209
190
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Philadelphia, Pennsylvania 19102
1225
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Philadelphia, Pennsylvania 19141
1225
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Phoenix, Arizona 85013
853
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Port Charlotte, Florida 33952
1178
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Providence, Rhode Island 02903
1424
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Rapid City, South Dakota 57701
520
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Richmond, Virginia 23219
1113
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Ridgewood, New Jersey 07450
1281
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Roanoke, Virginia 24104
979
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Rockledge, Florida 32955
1181
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Saginaw, Michigan 48601
823
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San Diego, California 92123
1139
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San Diego, California 92103
1142
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Silver Spring, Maryland 20903
1127
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Sioux Falls, South Dakota 57108
404
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South Bend, Indiana 46601
671
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South Bend, IN
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