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) (SHIELD-2)

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)

Study Overview

• Status: Terminated
• Conditions: Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Implantable Cardioverter Defibrillator
• Intervention / Treatment: Drug: Azimilide Dihydrochloride; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Brugge, Belgium, 8000
    • Forest Investigative Site 302
  • Charleroi, Belgium, 6000
    • Forest Investigative Site 303
  • Leuven, Belgium, 3000
    • Forest Investigative Site 300
  • Liège, Belgium, 4000
    • Forest Investigative Site 304
  • Yvoir, Belgium, 5530
    • Forest Investigative Site 301
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T5H 3V9
      • Forest Investigative Site 264
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z1M9
      • Forest Investigative Site 269
    • Victoria, British Columbia, Canada, V8R 4R2
      • Forest Investigative Site 252
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Forest Investigative Site 267
    • Kingston, Ontario, Canada, K7L2V7
      • Forest Investigative Site 253
    • Toronto, Ontario, Canada, M4N 3M5
      • Forest Investigative Site 259
    • Toronto, Ontario, Canada, M5B 1N9
      • Forest Investigative Site 263
  • Quebec
    • Montreal, Quebec, Canada, H2W 1T8
      • Forest Investigative Site 254
    • Montreal, Quebec, Canada, H3G1A4
      • Forest Investigative Site 250
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Forest Investigative Site 270
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 0W8
      • Forest Investigative Site 262
• Czech Republic
  • Brno, Czech Republic, 65691
    • Forest Investigative Site 750
  • Ceské Budejovice, Czech Republic, 37001
    • Forest Investigative Site 753
  • Olomouc, Czech Republic, 77520
    • Forest Investigative Site 751
  • Prague, Czech Republic, 15030
    • Forest Investigative Site 754
  • Sokolska, Czech Republic, 0581
    • Forest Investigative Site 752
• Denmark
  • Aalborg, Denmark, DK-9100
    • Forest Investigative Site 852
  • Copenhagen, Denmark, DK-2100
    • Forest Investigative Site 850
  • Esbjerg, Denmark, DK6700
    • Forest Investigative Site 854
  • Hellerup, Denmark, DK-2900
    • Forest Investigative Site 853
  • Odense, Denmark, DK-5000
    • Forest Investigative Site 851
• France
  • Grenoble, France, 38043
    • Forest Investigative Site 353
  • Lille, France, 59037
    • Forest Investigative Site 354
  • Montpellier, France, 34295
    • Forest Investigative Site 350
  • Nantes, France, 44800
    • Forest Investigative Site 358
  • Pessac, France, 33604
    • Forest Investigative Site 357
• Germany
  • Berlin, Germany, 14050
    • Forest Investigative Site 405
  • Gottingen, Germany, 37099
    • Forest Investigative Site 402
  • Heidelberg, Germany, 69120
    • Forest Investigative Site 410
  • Ludwigshafen, Germany, 67063
    • Forest Investigative Site 406
  • Mannheim, Germany, D-68167
    • Forest Investigative Site 401
• Israel
  • Ashkelon, Israel, 78278
    • Forest Investigative Site 450
  • Jerusalem, Israel, 91120
    • Forest Investigative Site 453
  • Tel Aviv, Israel, 64239
    • Forest Investigative Site 452
  • Tel Hashomer, Israel, 52621
    • Forest Investigative Site 451
• Italy
  • Ancona, Italy, 41060
    • Forest Investigative Site 504
  • Catania, Italy, 95124
    • Forest Investigative Site 502
• Netherlands
  • Breda, Netherlands, 4818 CK
    • Forest Investigative Site 552
  • Eindhoven, Netherlands, 5623
    • Forest Investigative Site 550
  • Zwolle, Netherlands, 8011 JW
    • Forest Investigative Site 555
• Poland
  • Gdansk, Poland, 80-952
    • Forest Investigative Site 706
  • Gdynia, Poland, 81-423
    • Forest Investigative Site 705
• Spain
  • Barcelona, Spain, 08036
    • Forest Investigative Site 604
  • Malaga, Spain, 29010
    • Forest Investigative Site 601
• Sweden
  • Lund, Sweden, 22185
    • Forest Investigative Site 800
  • Orebro, Sweden, 70185
    • Forest Investigative Site 805
  • Stockholm, Sweden, 11883
    • Forest Investigative Site 804
  • Stockholm, Sweden, 17176
    • Forest Investigative Site 802
  • Uppsala, Sweden, 75185
    • Forest Investigative Site 801
  • Vasteras, Sweden, 72189
    • Forest Investigative Site 803
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35211
      • Forest Investigative Site 053
    • Huntsville, Alabama, United States, 35801
      • Forest Investigative Site 048
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Forest Investigative Site 013
  • California
    • Los Angeles, California, United States, 99048
      • Forest Investigative Site 110
    • Merced, California, United States, 95340
      • Forest Investigative Site 022
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
      • Forest Investigative Site 060
    • Littleton, Colorado, United States, 80712
      • Forest Investigative Site 090
  • Delaware
    • Newark, Delaware, United States, 19718
      • Forest Investigative Site 041
  • Florida
    • Hollywood, Florida, United States, 33021
      • Forest Investigative Site 113
    • Jacksonville, Florida, United States, 32204
      • Forest Investigative Site 010
    • Lakeland, Florida, United States, 33805
      • Forest Investigative Site 035
    • Port Charlotte, Florida, United States, 33952
      • Forest Investigative Site 044
    • Rockledge, Florida, United States, 32955
      • Forest Investigative Site 062
    • Safety Harbor, Florida, United States, 34695
      • Forest Investigative Site 082
    • Zephyrhills, Florida, United States, 33542
      • Forest Investigative Site 006
  • Georgia
    • Augusta, Georgia, United States, 30901
      • Forest Investigative Site 123
  • Idaho
    • Boise, Idaho, United States, 83712
      • Forest Investigative Site 092
  • Indiana
    • Bloomington, Indiana, United States, 47402
      • Forest Investigative Site 012
    • Indianapolis, Indiana, United States, 46237
      • Forest Investigative Site 068
    • South Bend, Indiana, United States, 46601
      • Forest Investigative Site 087
  • Louisiana
    • Houma, Louisiana, United States, 70360
      • Forest Investigative Site 063
  • Maine
    • Auburn, Maine, United States, 04210
      • Forest Investigative Site 050
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Forest Investigative Site 030
    • Baltimore, Maryland, United States, 21237
      • Forest Investigative Site 058
    • Lanham, Maryland, United States, 20706
      • Forest Investigative Site 052
    • Silver Spring, Maryland, United States, 20903
      • Forest Investigative Site 118
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Forest Investigative Site 015
    • Brighton, Massachusetts, United States, 02135
      • Forest Investigative Site 091
  • Michigan
    • Saginaw, Michigan, United States, 48601
      • Forest Investigative Site 020
    • Southfield, Michigan, United States, 48075
      • Forest Investigative Site 085
    • Troy, Michigan, United States, 48085
      • Forest Investigative Site 079
    • Ypsilanti, Michigan, United States, 48197
      • Forest Investigative Site 034
  • Mississippi
    • Tupelo, Mississippi, United States, 38801
      • Forest Investigative Site 121
  • Missouri
    • St. Louis, Missouri, United States, 63110
      • Forest Investigative Site 088
    • St. Louis, Missouri, United States, 63125
      • Forest Investigative Site 100
  • New Jersey
    • Englewood,, New Jersey, United States, 07631
      • Forest Investigative Site 055
    • Ridgewood, New Jersey, United States, 07450
      • Forest Investigative Site 059
    • Warren, New Jersey, United States, 07059
      • Forest Investigative Site 106
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Forest Investigative Site 112
  • New York
    • Albany, New York, United States, 12205
      • Forest Investigative Site 018
    • Albany, New York, United States, 12211
      • Forest Investigative Site 069
    • New York, New York, United States, 10021
      • Forest Investigative Site 045
    • New York, New York, United States, 10032
      • Forest Investigative Site 122
    • Williamsville, New York, United States, 14221
      • Forest Investigative Site 075
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Forest Investigative Site 089
    • Greensboro, North Carolina, United States, 27401
      • Forest Investigative Site 116
  • Ohio
    • Canton, Ohio, United States, 44708
      • Forest Investigative Site 070
    • Cincinnati, Ohio, United States, 45219
      • Forest Investigative Site 064
    • Cincinnati, Ohio, United States, 45242
      • Forest Investigative Site 124
    • Columbus, Ohio, United States, 43214
      • Forest Investigative Site 043
    • Kettering, Ohio, United States, 45429
      • Forest Investigative Site 083
    • Toledo, Ohio, United States, 43615
      • Forest Investigative Site 109
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Forest Investigative Site 119
    • Tulsa, Oklahoma, United States, 74104
      • Forest Investigative Site 003
  • Pennsylvania
    • Camp Hill, Pennsylvania, United States, 17011
      • Forest Investigative Site 056
    • Erie, Pennsylvania, United States, 16502
      • Forest Investigative Site 081
    • Erie, Pennsylvania, United States, 16507
      • Forest Investigative Site 008
    • Hershey, Pennsylvania, United States, 17033
      • Forest Investigative Site 024
    • Philadelphia, Pennsylvania, United States, 19141
      • Forest Investigative Site 095
    • Wilkes-Barre, Pennsylvania, United States, 18711
      • Forest Investigative Site 005
    • Yardley, Pennsylvania, United States, 19067
      • Forest Investigative Site 107
    • York, Pennsylvania, United States, 17403
      • Forest Investigative Site 046
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Forest Investigative Site 084
  • South Carolina
    • Florence, South Carolina, United States, 29501
      • Forest Investigative Site 066
    • Greenville, South Carolina, United States, 29607
      • Forest Investigative Site 073
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Forest Investigative Site 014
    • Sioux Falls, South Dakota, United States, 57108
      • Forest Investigative Site 094
  • Texas
    • Corpus Christi, Texas, United States, 78404
      • Forest Investigative Site 029
    • Dallas, Texas, United States, 75390
      • Forest Investigative Site 028
    • Fort Worth, Texas, United States, 76104
      • Forest Investigative Site 111
    • Fort Worth,, Texas, United States, 76104
      • Forest Investigative Site 007
    • Houston, Texas, United States, 77030
      • Forest Investigative Site 125
    • Houston, Texas, United States, 77094
      • Forest Investigative Site 076
    • San Antonio, Texas, United States, 78229
      • Forest Investigative Site 074
  • Virginia
    • Chesapeake, Virginia, United States, 23320
      • Forest Investigative Site 016
    • Falls Church, Virginia, United States, 22042
      • Forest Investigative Site 004
    • Lynchburg, Virginia, United States, 24501
      • Forest Investigative Site 117
    • Newport News, Virginia, United States, 23601
      • Forest Investigative Site 065
    • Richmond, Virginia, United States, 23219
      • Forest Investigative Site 072
    • Roanoke, Virginia, United States, 24104
      • Forest Investigative Site 023
  • Wisconsin
    • Green Bay, Wisconsin, United States, 54301
      • Forest Investigative Site 071
    • Madison, Wisconsin, United States, 53715
      • Forest Investigative Site 042
    • Milwaukee, Wisconsin, United States, 53215
      • Forest Investigative Site 049

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Dose-matched placebo. Once daily, oral administration
Experimental: Azimilide; Azimilide 75 mg film coated tablets	Drug: Azimilide Dihydrochloride; Azimilide 75 mg. Once daily, oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first cardiovascular event	Time to first unplanned cardiovascular hospitalization, unplanned cardiovascular emergency department visit, or cardiovascular death in patients with an Implantable Cardioverter Defibrillator (ICD)	365 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first all-cause shock by the ICD	Time to first all-cause shock initiated by the Implantable Cardioverter Defibrillator	365 days
Time to first unplanned physician-office visit.	Time to the first unplanned physician-office visit.	365 days

Collaborators and Investigators

• Sponsor: Forest Laboratories
• Investigators: Study Director: David B Bharucha, MD, PhD, Forest Laboratories

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Anticipated): May 1, 2013
• Study Completion (Anticipated): June 1, 2013

Study Registration Dates

• First Submitted: November 1, 2011
• First Submitted That Met QC Criteria: November 2, 2011
• First Posted (Estimate): November 3, 2011

Study Record Updates

• Last Update Posted (Estimate): May 6, 2013
• Last Update Submitted That Met QC Criteria: May 2, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Heart Diseases; Cardiovascular Diseases; Emergencies; Arrhythmias, Cardiac; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Azimilide
• Other Study ID Numbers: AZM-MD-302