Clinical trial NCT01464476: 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)
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Implantable Cardioverter Defibrillator
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2011-11-03
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


Eligibility criteria: 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

Primary outcomes:
measure: Time to first cardiovascular event
timeFrame: 365 days
Secondary outcomes:
measure: Time to first all-cause shock by the ICD
timeFrame: 365 days
measure: Time to first unplanned physician-office visit.
timeFrame: 365 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Forest Investigative Site 053
state: Alabama
city: Huntsville
country: United States
facility: Forest Investigative Site 048
state: Alabama
city: Phoenix
country: United States
facility: Forest Investigative Site 013
state: Arizona
city: Los Angeles
country: United States
facility: Forest Investigative Site 110
state: California
city: Merced
country: United States
facility: Forest Investigative Site 022
state: California
city: Colorado Springs
country: United States
facility: Forest Investigative Site 060
state: Colorado
city: Littleton
country: United States
facility: Forest Investigative Site 090
state: Colorado
city: Newark
country: United States
facility: Forest Investigative Site 041
state: Delaware
city: Hollywood
country: United States
facility: Forest Investigative Site 113
state: Florida
city: Jacksonville
country: United States
facility: Forest Investigative Site 010
state: Florida
city: Lakeland
country: United States
facility: Forest Investigative Site 035
state: Florida
city: Port Charlotte
country: United States
facility: Forest Investigative Site 044
state: Florida
city: Rockledge
country: United States
facility: Forest Investigative Site 062
state: Florida
city: Safety Harbor
country: United States
facility: Forest Investigative Site 082
state: Florida
city: Zephyrhills
country: United States
facility: Forest Investigative Site 006
state: Florida
city: Augusta
country: United States
facility: Forest Investigative Site 123
state: Georgia
city: Boise
country: United States
facility: Forest Investigative Site 092
state: Idaho
city: Bloomington
country: United States
facility: Forest Investigative Site 012
state: Indiana
city: Indianapolis
country: United States
facility: Forest Investigative Site 068
state: Indiana
city: South Bend
country: United States
facility: Forest Investigative Site 087
state: Indiana
city: Houma
country: United States
facility: Forest Investigative Site 063
state: Louisiana
city: Auburn
country: United States
facility: Forest Investigative Site 050
state: Maine
city: Baltimore
country: United States
facility: Forest Investigative Site 030
state: Maryland
city: Baltimore
country: United States
facility: Forest Investigative Site 058
state: Maryland
city: Lanham
country: United States
facility: Forest Investigative Site 052
state: Maryland
city: Silver Spring
country: United States
facility: Forest Investigative Site 118
state: Maryland
city: Boston
country: United States
facility: Forest Investigative Site 015
state: Massachusetts
city: Brighton
country: United States
facility: Forest Investigative Site 091
state: Massachusetts
city: Saginaw
country: United States
facility: Forest Investigative Site 020
state: Michigan
city: Southfield
country: United States
facility: Forest Investigative Site 085
state: Michigan
city: Troy
country: United States
facility: Forest Investigative Site 079
state: Michigan
city: Ypsilanti
country: United States
facility: Forest Investigative Site 034
state: Michigan
city: Tupelo
country: United States
facility: Forest Investigative Site 121
state: Mississippi
city: St. Louis
country: United States
facility: Forest Investigative Site 088
state: Missouri
city: St. Louis
country: United States
facility: Forest Investigative Site 100
state: Missouri
city: Englewood,
country: United States
facility: Forest Investigative Site 055
state: New Jersey
city: Ridgewood
country: United States
facility: Forest Investigative Site 059
state: New Jersey
city: Warren
country: United States
facility: Forest Investigative Site 106
state: New Jersey
city: Albuquerque
country: United States
facility: Forest Investigative Site 112
state: New Mexico
city: Albany
country: United States
facility: Forest Investigative Site 018
state: New York
city: Albany
country: United States
facility: Forest Investigative Site 069
state: New York
city: New York
country: United States
facility: Forest Investigative Site 045
state: New York
city: New York
country: United States
facility: Forest Investigative Site 122
state: New York
city: Williamsville
country: United States
facility: Forest Investigative Site 075
state: New York
city: Chapel Hill
country: United States
facility: Forest Investigative Site 089
state: North Carolina
city: Greensboro
country: United States
facility: Forest Investigative Site 116
state: North Carolina
city: Canton
country: United States
facility: Forest Investigative Site 070
state: Ohio
city: Cincinnati
country: United States
facility: Forest Investigative Site 064
state: Ohio
city: Cincinnati
country: United States
facility: Forest Investigative Site 124
state: Ohio
city: Columbus
country: United States
facility: Forest Investigative Site 043
state: Ohio
city: Kettering
country: United States
facility: Forest Investigative Site 083
state: Ohio
city: Toledo
country: United States
facility: Forest Investigative Site 109
state: Ohio
city: Oklahoma City
country: United States
facility: Forest Investigative Site 119
state: Oklahoma
city: Tulsa
country: United States
facility: Forest Investigative Site 003
state: Oklahoma
city: Camp Hill
country: United States
facility: Forest Investigative Site 056
state: Pennsylvania
city: Erie
country: United States
facility: Forest Investigative Site 081
state: Pennsylvania
city: Erie
country: United States
facility: Forest Investigative Site 008
state: Pennsylvania
city: Hershey
country: United States
facility: Forest Investigative Site 024
state: Pennsylvania
city: Philadelphia
country: United States
facility: Forest Investigative Site 095
state: Pennsylvania
city: Wilkes-Barre
country: United States
facility: Forest Investigative Site 005
state: Pennsylvania
city: Yardley
country: United States
facility: Forest Investigative Site 107
state: Pennsylvania
city: York
country: United States
facility: Forest Investigative Site 046
state: Pennsylvania
city: Providence
country: United States
facility: Forest Investigative Site 084
state: Rhode Island
city: Florence
country: United States
facility: Forest Investigative Site 066
state: South Carolina
city: Greenville
country: United States
facility: Forest Investigative Site 073
state: South Carolina
city: Rapid City
country: United States
facility: Forest Investigative Site 014
state: South Dakota
city: Sioux Falls
country: United States
facility: Forest Investigative Site 094
state: South Dakota
city: Corpus Christi
country: United States
facility: Forest Investigative Site 029
state: Texas
city: Dallas
country: United States
facility: Forest Investigative Site 028
state: Texas
city: Fort Worth,
country: United States
facility: Forest Investigative Site 007
state: Texas
city: Fort Worth
country: United States
facility: Forest Investigative Site 111
state: Texas
city: Houston
country: United States
facility: Forest Investigative Site 125
state: Texas
city: Houston
country: United States
facility: Forest Investigative Site 076
state: Texas
city: San Antonio
country: United States
facility: Forest Investigative Site 074
state: Texas
city: Chesapeake
country: United States
facility: Forest Investigative Site 016
state: Virginia
city: Falls Church
country: United States
facility: Forest Investigative Site 004
state: Virginia
city: Lynchburg
country: United States
facility: Forest Investigative Site 117
state: Virginia
city: Newport News
country: United States
facility: Forest Investigative Site 065
state: Virginia
city: Richmond
country: United States
facility: Forest Investigative Site 072
state: Virginia
city: Roanoke
country: United States
facility: Forest Investigative Site 023
state: Virginia
city: Green Bay
country: United States
facility: Forest Investigative Site 071
state: Wisconsin
city: Madison
country: United States
facility: Forest Investigative Site 042
state: Wisconsin
city: Milwaukee
country: United States
facility: Forest Investigative Site 049
state: Wisconsin
city: Brugge
country: Belgium
facility: Forest Investigative Site 302
city: Charleroi
country: Belgium
facility: Forest Investigative Site 303
city: Leuven
country: Belgium
facility: Forest Investigative Site 300
city: Liège
country: Belgium
facility: Forest Investigative Site 304
city: Yvoir
country: Belgium
facility: Forest Investigative Site 301
city: Edmonton
country: Canada
facility: Forest Investigative Site 264
state: Alberta
city: Vancouver
country: Canada
facility: Forest Investigative Site 269
state: British Columbia
city: Victoria
country: Canada
facility: Forest Investigative Site 252
state: British Columbia
city: Hamilton
country: Canada
facility: Forest Investigative Site 267
state: Ontario
city: Kingston
country: Canada
facility: Forest Investigative Site 253
state: Ontario
city: Toronto
country: Canada
facility: Forest Investigative Site 259
state: Ontario
city: Toronto
country: Canada
facility: Forest Investigative Site 263
state: Ontario
city: Montreal
country: Canada
facility: Forest Investigative Site 254
state: Quebec
city: Montreal
country: Canada
facility: Forest Investigative Site 250
state: Quebec
city: Sherbrooke
country: Canada
facility: Forest Investigative Site 270
state: Quebec
city: Saskatoon
country: Canada
facility: Forest Investigative Site 262
state: Saskatchewan
city: Brno
country: Czech Republic
facility: Forest Investigative Site 750
city: Ceské Budejovice
country: Czech Republic
facility: Forest Investigative Site 753
city: Olomouc
country: Czech Republic
facility: Forest Investigative Site 751
city: Prague
country: Czech Republic
facility: Forest Investigative Site 754
city: Sokolska
country: Czech Republic
facility: Forest Investigative Site 752
city: Aalborg
country: Denmark
facility: Forest Investigative Site 852
city: Copenhagen
country: Denmark
facility: Forest Investigative Site 850
city: Esbjerg
country: Denmark
facility: Forest Investigative Site 854
city: Hellerup
country: Denmark
facility: Forest Investigative Site 853
city: Odense
country: Denmark
facility: Forest Investigative Site 851
city: Grenoble
country: France
facility: Forest Investigative Site 353
city: Lille
country: France
facility: Forest Investigative Site 354
city: Montpellier
country: France
facility: Forest Investigative Site 350
city: Nantes
country: France
facility: Forest Investigative Site 358
city: Pessac
country: France
facility: Forest Investigative Site 357
city: Berlin
country: Germany
facility: Forest Investigative Site 405
city: Gottingen
country: Germany
facility: Forest Investigative Site 402
city: Heidelberg
country: Germany
facility: Forest Investigative Site 410
city: Ludwigshafen
country: Germany
facility: Forest Investigative Site 406
city: Mannheim
country: Germany
facility: Forest Investigative Site 401
city: Ashkelon
country: Israel
facility: Forest Investigative Site 450
city: Jerusalem
country: Israel
facility: Forest Investigative Site 453
city: Tel Aviv
country: Israel
facility: Forest Investigative Site 452
city: Tel Hashomer
country: Israel
facility: Forest Investigative Site 451
city: Ancona
country: Italy
facility: Forest Investigative Site 504
city: Catania
country: Italy
facility: Forest Investigative Site 502
city: Breda
country: Netherlands
facility: Forest Investigative Site 552
city: Eindhoven
country: Netherlands
facility: Forest Investigative Site 550
city: Zwolle
country: Netherlands
facility: Forest Investigative Site 555
city: Gdansk
country: Poland
facility: Forest Investigative Site 706
city: Gdynia
country: Poland
facility: Forest Investigative Site 705
city: Barcelona
country: Spain
facility: Forest Investigative Site 604
city: Malaga
country: Spain
facility: Forest Investigative Site 601
city: Lund
country: Sweden
facility: Forest Investigative Site 800
city: Orebro
country: Sweden
facility: Forest Investigative Site 805
city: Stockholm
country: Sweden
facility: Forest Investigative Site 804
city: Stockholm
country: Sweden
facility: Forest Investigative Site 802
city: Uppsala
country: Sweden
facility: Forest Investigative Site 801
city: Vasteras
country: Sweden
facility: Forest Investigative Site 803
Study officials:
affiliation: Forest Laboratories
name: David B Bharucha, MD, PhD
role: STUDY_DIRECTOR
References: