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)
NCT ID: NCT01464476
Last Updated: 2013-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
240 participants
INTERVENTIONAL
2011-11-30
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Azimilide
Azimilide 75 mg film coated tablets
Azimilide Dihydrochloride
Azimilide 75 mg. Once daily, oral administration
Placebo
Placebo
Dose-matched placebo. Once daily, oral administration
Interventions
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Azimilide Dihydrochloride
Azimilide 75 mg. Once daily, oral administration
Placebo
Dose-matched placebo. Once daily, oral administration
Eligibility Criteria
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Inclusion Criteria
* Have a left ventricular ejection fraction \<= 0.40
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Forest Laboratories
INDUSTRY
Responsible Party
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Principal Investigators
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David B Bharucha, MD, PhD
Role: STUDY_DIRECTOR
Forest Laboratories
Locations
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Forest Investigative Site 053
Birmingham, Alabama, United States
Forest Investigative Site 048
Huntsville, Alabama, United States
Forest Investigative Site 013
Phoenix, Arizona, United States
Forest Investigative Site 110
Los Angeles, California, United States
Forest Investigative Site 022
Merced, California, United States
Forest Investigative Site 060
Colorado Springs, Colorado, United States
Forest Investigative Site 090
Littleton, Colorado, United States
Forest Investigative Site 041
Newark, Delaware, United States
Forest Investigative Site 113
Hollywood, Florida, United States
Forest Investigative Site 010
Jacksonville, Florida, United States
Forest Investigative Site 035
Lakeland, Florida, United States
Forest Investigative Site 044
Port Charlotte, Florida, United States
Forest Investigative Site 062
Rockledge, Florida, United States
Forest Investigative Site 082
Safety Harbor, Florida, United States
Forest Investigative Site 006
Zephyrhills, Florida, United States
Forest Investigative Site 123
Augusta, Georgia, United States
Forest Investigative Site 092
Boise, Idaho, United States
Forest Investigative Site 012
Bloomington, Indiana, United States
Forest Investigative Site 068
Indianapolis, Indiana, United States
Forest Investigative Site 087
South Bend, Indiana, United States
Forest Investigative Site 063
Houma, Louisiana, United States
Forest Investigative Site 050
Auburn, Maine, United States
Forest Investigative Site 030
Baltimore, Maryland, United States
Forest Investigative Site 058
Baltimore, Maryland, United States
Forest Investigative Site 052
Lanham, Maryland, United States
Forest Investigative Site 118
Silver Spring, Maryland, United States
Forest Investigative Site 015
Boston, Massachusetts, United States
Forest Investigative Site 091
Brighton, Massachusetts, United States
Forest Investigative Site 020
Saginaw, Michigan, United States
Forest Investigative Site 085
Southfield, Michigan, United States
Forest Investigative Site 079
Troy, Michigan, United States
Forest Investigative Site 034
Ypsilanti, Michigan, United States
Forest Investigative Site 121
Tupelo, Mississippi, United States
Forest Investigative Site 088
St Louis, Missouri, United States
Forest Investigative Site 100
St Louis, Missouri, United States
Forest Investigative Site 055
Englewood, New Jersey, United States
Forest Investigative Site 059
Ridgewood, New Jersey, United States
Forest Investigative Site 106
Warren Township, New Jersey, United States
Forest Investigative Site 112
Albuquerque, New Mexico, United States
Forest Investigative Site 018
Albany, New York, United States
Forest Investigative Site 069
Albany, New York, United States
Forest Investigative Site 045
New York, New York, United States
Forest Investigative Site 122
New York, New York, United States
Forest Investigative Site 075
Williamsville, New York, United States
Forest Investigative Site 089
Chapel Hill, North Carolina, United States
Forest Investigative Site 116
Greensboro, North Carolina, United States
Forest Investigative Site 070
Canton, Ohio, United States
Forest Investigative Site 064
Cincinnati, Ohio, United States
Forest Investigative Site 124
Cincinnati, Ohio, United States
Forest Investigative Site 043
Columbus, Ohio, United States
Forest Investigative Site 083
Kettering, Ohio, United States
Forest Investigative Site 109
Toledo, Ohio, United States
Forest Investigative Site 119
Oklahoma City, Oklahoma, United States
Forest Investigative Site 003
Tulsa, Oklahoma, United States
Forest Investigative Site 056
Camp Hill, Pennsylvania, United States
Forest Investigative Site 081
Erie, Pennsylvania, United States
Forest Investigative Site 008
Erie, Pennsylvania, United States
Forest Investigative Site 024
Hershey, Pennsylvania, United States
Forest Investigative Site 095
Philadelphia, Pennsylvania, United States
Forest Investigative Site 005
Wilkes-Barre, Pennsylvania, United States
Forest Investigative Site 107
Yardley, Pennsylvania, United States
Forest Investigative Site 046
York, Pennsylvania, United States
Forest Investigative Site 084
Providence, Rhode Island, United States
Forest Investigative Site 066
Florence, South Carolina, United States
Forest Investigative Site 073
Greenville, South Carolina, United States
Forest Investigative Site 014
Rapid City, South Dakota, United States
Forest Investigative Site 094
Sioux Falls, South Dakota, United States
Forest Investigative Site 029
Corpus Christi, Texas, United States
Forest Investigative Site 028
Dallas, Texas, United States
Forest Investigative Site 007
Fort Worth, Texas, United States
Forest Investigative Site 111
Fort Worth, Texas, United States
Forest Investigative Site 125
Houston, Texas, United States
Forest Investigative Site 076
Houston, Texas, United States
Forest Investigative Site 074
San Antonio, Texas, United States
Forest Investigative Site 016
Chesapeake, Virginia, United States
Forest Investigative Site 004
Falls Church, Virginia, United States
Forest Investigative Site 117
Lynchburg, Virginia, United States
Forest Investigative Site 065
Newport News, Virginia, United States
Forest Investigative Site 072
Richmond, Virginia, United States
Forest Investigative Site 023
Roanoke, Virginia, United States
Forest Investigative Site 071
Green Bay, Wisconsin, United States
Forest Investigative Site 042
Madison, Wisconsin, United States
Forest Investigative Site 049
Milwaukee, Wisconsin, United States
Forest Investigative Site 302
Bruges, , Belgium
Forest Investigative Site 303
Charleroi, , Belgium
Forest Investigative Site 300
Leuven, , Belgium
Forest Investigative Site 304
Liège, , Belgium
Forest Investigative Site 301
Yvoir, , Belgium
Forest Investigative Site 264
Edmonton, Alberta, Canada
Forest Investigative Site 269
Vancouver, British Columbia, Canada
Forest Investigative Site 252
Victoria, British Columbia, Canada
Forest Investigative Site 267
Hamilton, Ontario, Canada
Forest Investigative Site 253
Kingston, Ontario, Canada
Forest Investigative Site 259
Toronto, Ontario, Canada
Forest Investigative Site 263
Toronto, Ontario, Canada
Forest Investigative Site 254
Montreal, Quebec, Canada
Forest Investigative Site 250
Montreal, Quebec, Canada
Forest Investigative Site 270
Sherbrooke, Quebec, Canada
Forest Investigative Site 262
Saskatoon, Saskatchewan, Canada
Forest Investigative Site 750
Brno, , Czechia
Forest Investigative Site 753
České Budějovice, , Czechia
Forest Investigative Site 751
Olomouc, , Czechia
Forest Investigative Site 754
Prague, , Czechia
Forest Investigative Site 752
Sokolska, , Czechia
Forest Investigative Site 852
Aalborg, , Denmark
Forest Investigative Site 850
Copenhagen, , Denmark
Forest Investigative Site 854
Esbjerg, , Denmark
Forest Investigative Site 853
Hellerup, , Denmark
Forest Investigative Site 851
Odense, , Denmark
Forest Investigative Site 353
Grenoble, , France
Forest Investigative Site 354
Lille, , France
Forest Investigative Site 350
Montpellier, , France
Forest Investigative Site 358
Nantes, , France
Forest Investigative Site 357
Pessac, , France
Forest Investigative Site 405
Berlin, , Germany
Forest Investigative Site 402
Göttingen, , Germany
Forest Investigative Site 410
Heidelberg, , Germany
Forest Investigative Site 406
Ludwigshafen, , Germany
Forest Investigative Site 401
Mannheim, , Germany
Forest Investigative Site 450
Ashkelon, , Israel
Forest Investigative Site 453
Jerusalem, , Israel
Forest Investigative Site 452
Tel Aviv, , Israel
Forest Investigative Site 451
Tel Litwinsky, , Israel
Forest Investigative Site 504
Ancona, , Italy
Forest Investigative Site 502
Catania, , Italy
Forest Investigative Site 552
Breda, , Netherlands
Forest Investigative Site 550
Eindhoven, , Netherlands
Forest Investigative Site 555
Zwolle, , Netherlands
Forest Investigative Site 706
Gdansk, , Poland
Forest Investigative Site 705
Gdynia, , Poland
Forest Investigative Site 604
Barcelona, , Spain
Forest Investigative Site 601
Málaga, , Spain
Forest Investigative Site 800
Lund, , Sweden
Forest Investigative Site 805
Örebro, , Sweden
Forest Investigative Site 804
Stockholm, , Sweden
Forest Investigative Site 802
Stockholm, , Sweden
Forest Investigative Site 801
Uppsala, , Sweden
Forest Investigative Site 803
Västerås, , Sweden
Countries
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Other Identifiers
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AZM-MD-302
Identifier Type: -
Identifier Source: org_study_id
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