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)
- Conditions
- Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesImplantable Cardioverter Defibrillator
- Interventions
- Drug: Placebo
- Registration Number
- NCT01464476
- Lead Sponsor
- Forest Laboratories
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 240
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Azimilide Azimilide Dihydrochloride Azimilide 75 mg film coated tablets Placebo Placebo -
- Primary Outcome Measures
Name Time Method Time to first cardiovascular event 365 days 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
Name Time Method Time to first all-cause shock by the ICD 365 days Time to first all-cause shock initiated by the Implantable Cardioverter Defibrillator
Time to first unplanned physician-office visit. 365 days Time to the first unplanned physician-office visit.
Trial Locations
- Locations (138)
Forest Investigative Site 046
🇺🇸York, Pennsylvania, United States
Forest Investigative Site 259
🇨🇦Toronto, Ontario, Canada
Forest Investigative Site 095
🇺🇸Philadelphia, Pennsylvania, United States
Forest Investigative Site 118
🇺🇸Silver Spring, Maryland, United States
Forest Investigative Site 068
🇺🇸Indianapolis, Indiana, United States
Forest Investigative Site 015
🇺🇸Boston, Massachusetts, United States
Forest Investigative Site 300
🇧🇪Leuven, Belgium
Forest Investigative Site 304
🇧🇪Liège, Belgium
Forest Investigative Site 074
🇺🇸San Antonio, Texas, United States
Forest Investigative Site 753
🇨🇿Ceské Budejovice, Czech Republic
Forest Investigative Site 754
🇨🇿Prague, Czech Republic
Forest Investigative Site 262
🇨🇦Saskatoon, Saskatchewan, Canada
Forest Investigative Site 750
🇨🇿Brno, Czech Republic
Forest Investigative Site 853
🇩🇰Hellerup, Denmark
Forest Investigative Site 852
🇩🇰Aalborg, Denmark
Forest Investigative Site 090
🇺🇸Littleton, Colorado, United States
Forest Investigative Site 048
🇺🇸Huntsville, Alabama, United States
Forest Investigative Site 010
🇺🇸Jacksonville, Florida, United States
Forest Investigative Site 052
🇺🇸Lanham, Maryland, United States
Forest Investigative Site 062
🇺🇸Rockledge, Florida, United States
Forest Investigative Site 087
🇺🇸South Bend, Indiana, United States
Forest Investigative Site 060
🇺🇸Colorado Springs, Colorado, United States
Forest Investigative Site 082
🇺🇸Safety Harbor, Florida, 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 079
🇺🇸Troy, Michigan, United States
Forest Investigative Site 121
🇺🇸Tupelo, Mississippi, United States
Forest Investigative Site 020
🇺🇸Saginaw, Michigan, United States
Forest Investigative Site 088
🇺🇸St. Louis, Missouri, United States
Forest Investigative Site 112
🇺🇸Albuquerque, New Mexico, United States
Forest Investigative Site 100
🇺🇸St. Louis, Missouri, United States
Forest Investigative Site 124
🇺🇸Cincinnati, Ohio, United States
Forest Investigative Site 083
🇺🇸Kettering, Ohio, United States
Forest Investigative Site 116
🇺🇸Greensboro, North Carolina, United States
Forest Investigative Site 070
🇺🇸Canton, Ohio, United States
Forest Investigative Site 076
🇺🇸Houston, Texas, United States
Forest Investigative Site 850
🇩🇰Copenhagen, Denmark
Forest Investigative Site 353
🇫🇷Grenoble, France
Forest Investigative Site 555
🇳🇱Zwolle, Netherlands
Forest Investigative Site 604
🇪🇸Barcelona, Spain
Forest Investigative Site 018
🇺🇸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 012
🇺🇸Bloomington, Indiana, United States
Forest Investigative Site 034
🇺🇸Ypsilanti, Michigan, United States
Forest Investigative Site 123
🇺🇸Augusta, Georgia, United States
Forest Investigative Site 091
🇺🇸Brighton, Massachusetts, United States
Forest Investigative Site 092
🇺🇸Boise, Idaho, United States
Forest Investigative Site 004
🇺🇸Falls Church, Virginia, United States
Forest Investigative Site 059
🇺🇸Ridgewood, New Jersey, United States
Forest Investigative Site 044
🇺🇸Port Charlotte, Florida, United States
Forest Investigative Site 063
🇺🇸Houma, Louisiana, United States
Forest Investigative Site 113
🇺🇸Hollywood, Florida, United States
Forest Investigative Site 041
🇺🇸Newark, Delaware, United States
Forest Investigative Site 110
🇺🇸Los Angeles, California, United States
Forest Investigative Site 022
🇺🇸Merced, California, United States
Forest Investigative Site 006
🇺🇸Zephyrhills, Florida, United States
Forest Investigative Site 085
🇺🇸Southfield, Michigan, United States
Forest Investigative Site 055
🇺🇸Englewood,, New Jersey, United States
Forest Investigative Site 106
🇺🇸Warren, New Jersey, United States
Forest Investigative Site 064
🇺🇸Cincinnati, Ohio, United States
Forest Investigative Site 043
🇺🇸Columbus, Ohio, United States
Forest Investigative Site 109
🇺🇸Toledo, Ohio, United States
Forest Investigative Site 056
🇺🇸Camp Hill, Pennsylvania, United States
Forest Investigative Site 003
🇺🇸Tulsa, Oklahoma, United States
Forest Investigative Site 008
🇺🇸Erie, Pennsylvania, United States
Forest Investigative Site 081
🇺🇸Erie, Pennsylvania, United States
Forest Investigative Site 024
🇺🇸Hershey, Pennsylvania, United States
Forest Investigative Site 005
🇺🇸Wilkes-Barre, Pennsylvania, United States
Forest Investigative Site 107
🇺🇸Yardley, Pennsylvania, United States
Forest Investigative Site 084
🇺🇸Providence, Rhode Island, United States
Forest Investigative Site 066
🇺🇸Florence, South Carolina, United States
Forest Investigative Site 014
🇺🇸Rapid City, South Dakota, United States
Forest Investigative Site 073
🇺🇸Greenville, South Carolina, United States
Forest Investigative Site 094
🇺🇸Sioux Falls, South Dakota, United States
Forest Investigative Site 029
🇺🇸Corpus Christi, Texas, United States
Forest Investigative Site 007
🇺🇸Fort Worth,, Texas, United States
Forest Investigative Site 028
🇺🇸Dallas, Texas, United States
Forest Investigative Site 125
🇺🇸Houston, Texas, United States
Forest Investigative Site 016
🇺🇸Chesapeake, Virginia, United States
Forest Investigative Site 111
🇺🇸Fort Worth, Texas, United States
Forest Investigative Site 117
🇺🇸Lynchburg, Virginia, United States
Forest Investigative Site 072
🇺🇸Richmond, Virginia, United States
Forest Investigative Site 023
🇺🇸Roanoke, Virginia, United States
Forest Investigative Site 065
🇺🇸Newport News, Virginia, United States
Forest Investigative Site 042
🇺🇸Madison, Wisconsin, United States
Forest Investigative Site 071
🇺🇸Green Bay, Wisconsin, United States
Forest Investigative Site 303
🇧🇪Charleroi, Belgium
Forest Investigative Site 301
🇧🇪Yvoir, Belgium
Forest Investigative Site 264
🇨🇦Edmonton, Alberta, Canada
Forest Investigative Site 302
🇧🇪Brugge, Belgium
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 254
🇨🇦Montreal, Quebec, Canada
Forest Investigative Site 263
🇨🇦Toronto, Ontario, Canada
Forest Investigative Site 270
🇨🇦Sherbrooke, Quebec, Canada
Forest Investigative Site 250
🇨🇦Montreal, Quebec, Canada
Forest Investigative Site 751
🇨🇿Olomouc, Czech Republic
Forest Investigative Site 854
🇩🇰Esbjerg, Denmark
Forest Investigative Site 752
🇨🇿Sokolska, Czech Republic
Forest Investigative Site 354
🇫🇷Lille, France
Forest Investigative Site 851
🇩🇰Odense, Denmark
Forest Investigative Site 350
🇫🇷Montpellier, France
Forest Investigative Site 406
🇩🇪Ludwigshafen, Germany
Forest Investigative Site 402
🇩🇪Gottingen, Germany
Forest Investigative Site 358
🇫🇷Nantes, France
Forest Investigative Site 357
🇫🇷Pessac, France
Forest Investigative Site 405
🇩🇪Berlin, Germany
Forest Investigative Site 410
🇩🇪Heidelberg, Germany
Forest Investigative Site 401
🇩🇪Mannheim, Germany
Forest Investigative Site 450
🇮🇱Ashkelon, Israel
Forest Investigative Site 453
🇮🇱Jerusalem, Israel
Forest Investigative Site 504
🇮🇹Ancona, Italy
Forest Investigative Site 502
🇮🇹Catania, Italy
Forest Investigative Site 451
🇮🇱Tel Hashomer, Israel
Forest Investigative Site 452
🇮🇱Tel Aviv, Israel
Forest Investigative Site 706
🇵🇱Gdansk, Poland
Forest Investigative Site 552
🇳🇱Breda, Netherlands
Forest Investigative Site 550
🇳🇱Eindhoven, Netherlands
Forest Investigative Site 705
🇵🇱Gdynia, Poland
Forest Investigative Site 601
🇪🇸Malaga, Spain
Forest Investigative Site 804
🇸🇪Stockholm, Sweden
Forest Investigative Site 802
🇸🇪Stockholm, Sweden
Forest Investigative Site 800
🇸🇪Lund, Sweden
Forest Investigative Site 805
🇸🇪Orebro, Sweden
Forest Investigative Site 801
🇸🇪Uppsala, Sweden
Forest Investigative Site 803
🇸🇪Vasteras, Sweden
Forest Investigative Site 069
🇺🇸Albany, New York, United States
Forest Investigative Site 053
🇺🇸Birmingham, Alabama, United States
Forest Investigative Site 013
🇺🇸Phoenix, Arizona, United States
Forest Investigative Site 089
🇺🇸Chapel Hill, North Carolina, United States
Forest Investigative Site 119
🇺🇸Oklahoma City, Oklahoma, United States
Forest Investigative Site 049
🇺🇸Milwaukee, Wisconsin, United States
Forest Investigative Site 035
🇺🇸Lakeland, Florida, United States