Clinical trial NCT00751738: Long Term Safety of 125 mg Per Day of Oral Azimilide in Patients With Implantable Cardioverter Defibrillator (ICDs)
Official title: A Multi-center, Open-label, Follow-up Study to Assess the Long-term Safety of 125 mg Per Day of Oral Azimilide Dihydrochloride in Patients With an Implantable Cardioverter Defibrillator
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arrhythmias
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2008-09-12
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label, multi-center, long-term, (open-ended) safety study with 125 mg per day of azimilide in patients who completed protocol 2000098.


Eligibility criteria: Inclusion Criteria:

* patients who completed at least 12 months on study 2000098 before inclusion in this study

Exclusion Criteria:

* breast feeding or plan to become pregnant
* used ticlopidine
* were taking Class I or other Class III drugs

Primary outcomes:
measure: safety of azimilide in this patient population
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Research Facility
state: Alabama
city: Little Rock
country: United States
facility: Research Facility
state: Arkansas
city: LaJolla
country: United States
facility: Research Facility
state: California
city: Loma Linda
country: United States
facility: Research Facility
state: California
city: Sacramento
country: United States
facility: Research Facility
state: California
city: Colorado Springs
country: United States
facility: Research Facility
state: Colorado
city: Bridgeport
country: United States
facility: Research Facility
state: Connecticut
city: Washington
country: United States
facility: Research Facility
state: District of Columbia
city: Ft. Lauderdale
country: United States
facility: Research Facility
state: Florida
city: Ft. Myers
country: United States
facility: Research Facility
state: Florida
city: Jacksonville
country: United States
facility: Research Facility
state: Florida
city: Maywood
country: United States
facility: Research Facility
state: Illinois
city: Kansas City
country: United States
facility: Research Facility
state: Kansas
city: Portland
country: United States
facility: Research Facility
state: Maine
city: Baltimore
country: United States
facility: Research Facility
state: Maryland
city: Baltimore
country: United States
facility: Research Facility
state: Maryland
city: Boston
country: United States
facility: Research Facility
state: Massachusetts
city: Burlington
country: United States
facility: Research Facility
state: Massachusetts
city: Worcester
country: United States
facility: Research Facility
state: Massachusetts
city: Warren
country: United States
facility: Research Facility
state: New Jersey
city: Brooklyn
country: United States
facility: Research Facility
state: New York
city: Johnson City
country: United States
facility: Research Facility
state: New York
city: New York
country: United States
facility: Research Facility
state: New York
city: New York
country: United States
facility: Research Facility
state: New York
city: Rochester
country: United States
facility: Research Facility
state: New York
city: Rochester
country: United States
facility: Research Facility
state: New York
city: West Orange
country: United States
facility: Research Facility
state: New York
city: Williamsville
country: United States
facility: Research Facility
state: New York
city: Durham
country: United States
facility: Research Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Research Facility
state: North Carolina
city: Cincinnati
country: United States
facility: Research Facility
state: Ohio
city: Toledo
country: United States
facility: Research Facility
state: Ohio
city: Tulsa
country: United States
facility: Research Facility
state: Oklahoma
city: Erie
country: United States
facility: Research Facility
state: Pennsylvania
city: Hershey
country: United States
facility: Research Facility
state: Pennsylvania
city: Lancaster
country: United States
facility: Research Facility
state: Pennsylvania
city: Philadelphia
country: United States
facility: Research Facility
state: Pennsylvania
city: Charleston
country: United States
facility: Research Facility
state: South Carolina
city: Columbia
country: United States
facility: Research Site
state: South Carolina
city: Germantown
country: United States
facility: Research Facility
state: Tennessee
city: Nashville
country: United States
facility: Research Facility
state: Tennessee
city: Dallas
country: United States
facility: Research Facility
state: Texas
city: Dallas
country: United States
facility: Research Facility
state: Texas
city: Houston
country: United States
facility: Research Facility
state: Texas
city: Salt Lake City
country: United States
facility: Research Facility
state: Utah
city: Charlottesville
country: United States
facility: Research Facility
state: Virginia
city: Fairfax
country: United States
facility: Research Facility
state: Virginia
city: Spokane
country: United States
facility: Research Facility
state: Washington
city: Green Bay
country: United States
facility: Research Facility
state: Wisconsin
city: Milwaukee
country: United States
facility: Research Facility
state: Wisconsin
city: Brugge
country: Belgium
facility: Research Facility
city: Mont Godinne
country: Belgium
facility: Research Facility
city: Victoria
country: Canada
facility: Research Facility
state: British Columbia
city: St. Johns
country: Canada
facility: Research Facility
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Research Site
state: Nova Scotia
city: Hamilton
country: Canada
facility: Research Facility
state: Ontario
city: Ottawa
country: Canada
facility: Research Facility
state: Ontario
city: Toronto
country: Canada
facility: Research Facility
state: Ontario
city: Montreal
country: Canada
facility: Research Facility
state: Quebec
city: Quebec
country: Canada
facility: Research Facility
city: Lille Cedex
country: France
facility: Research Facility
city: Nantes Cedex
country: France
facility: Research Facility
city: Paris Cedex
country: France
facility: Research Facility
city: Pessac Cedex
country: France
facility: Research Facility
city: Tours Cedex
country: France
facility: Research Facility
city: Bad Bevensen
country: Germany
facility: Research Facility
city: Berlin
country: Germany
facility: Research Facility
city: Brandenburg an der Havel
country: Germany
facility: Research Facility
city: Coburg
country: Germany
facility: Research Facility
city: Frankfurt
country: Germany
facility: Research Facility
city: Freiburg
country: Germany
facility: Research Facility
city: Hamburg
country: Germany
facility: Research Facility
city: Heidelberg
country: Germany
facility: Research Facility
city: Ludwigshafen
country: Germany
facility: Research Facility
city: Magdeburg
country: Germany
facility: Research Facility
city: Mannheim
country: Germany
facility: Research Facility
city: Tubingen
country: Germany
facility: Research Facility
city: Gdansk
country: Poland
facility: Research Facility
city: Katowice
country: Poland
facility: Research Facility
city: Lublin
country: Poland
facility: Research Facility
city: Szczecin
country: Poland
facility: Research Facility
city: Warszawa
country: Poland
facility: Research Facility
city: Barcelona
country: Spain
facility: Research Facility
city: Madrid
country: Spain
facility: Research Facility
city: Malaga
country: Spain
facility: Research Facility
city: Valencia
country: Spain
facility: Research Facility
Study officials:
affiliation: Procter and Gamble
name: Jose M Brum, MD
role: STUDY_DIRECTOR
References: