Long Term Safety of 125 mg Per Day of Oral Azimilide in Patients With Implantable Cardioverter Defibrillator (ICDs)

January 31, 2017 updated by: Forest Laboratories

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

330

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brugge, Belgium
        • Research Facility
      • Mont Godinne, Belgium
        • Research Facility
  • Canada
      • Quebec, Canada
        • Research Facility
    • British Columbia
      • Victoria, British Columbia, Canada
        • Research Facility
    • Newfoundland and Labrador
      • St. Johns, Newfoundland and Labrador, Canada
        • Research Facility
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Research Site
    • Ontario
      • Hamilton, Ontario, Canada
        • Research Facility
      • Ottawa, Ontario, Canada
        • Research Facility
      • Toronto, Ontario, Canada
        • Research Facility
    • Quebec
      • Montreal, Quebec, Canada
        • Research Facility
  • France
      • Lille Cedex, France
        • Research Facility
      • Nantes Cedex, France
        • Research Facility
      • Paris Cedex, France
        • Research Facility
      • Pessac Cedex, France
        • Research Facility
      • Tours Cedex, France
        • Research Facility
  • Germany
      • Bad Bevensen, Germany
        • Research Facility
      • Berlin, Germany
        • Research Facility
      • Brandenburg an der Havel, Germany
        • Research Facility
      • Coburg, Germany
        • Research Facility
      • Frankfurt, Germany
        • Research Facility
      • Freiburg, Germany
        • Research Facility
      • Hamburg, Germany
        • Research Facility
      • Heidelberg, Germany
        • Research Facility
      • Ludwigshafen, Germany
        • Research Facility
      • Magdeburg, Germany
        • Research Facility
      • Mannheim, Germany
        • Research Facility
      • Tubingen, Germany
        • Research Facility
  • Poland
      • Gdansk, Poland
        • Research Facility
      • Katowice, Poland
        • Research Facility
      • Lublin, Poland
        • Research Facility
      • Szczecin, Poland
        • Research Facility
      • Warszawa, Poland
        • Research Facility
  • Spain
      • Barcelona, Spain
        • Research Facility
      • Madrid, Spain
        • Research Facility
      • Malaga, Spain
        • Research Facility
      • Valencia, Spain
        • Research Facility
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Research Facility
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Research Facility
    • California
      • LaJolla, California, United States, 92037
        • Research Facility
      • Loma Linda, California, United States, 932354
        • Research Facility
      • Sacramento, California, United States, 95819
        • Research Facility
    • Colorado
      • Colorado Springs, Colorado, United States, 80910
        • Research Facility
    • Connecticut
      • Bridgeport, Connecticut, United States, 06610
        • Research Facility
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Research Facility
    • Florida
      • Ft. Lauderdale, Florida, United States, 33308
        • Research Facility
      • Ft. Myers, Florida, United States, 33919
        • Research Facility
      • Jacksonville, Florida, United States, 32207
        • Research Facility
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Research Facility
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Research Facility
    • Maine
      • Portland, Maine, United States, 04102
        • Research Facility
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Research Facility
      • Baltimore, Maryland, United States, 21204
        • Research Facility
    • Massachusetts
      • Boston, Massachusetts, United States, 02135
        • Research Facility
      • Burlington, Massachusetts, United States, 01805
        • Research Facility
      • Worcester, Massachusetts, United States, 01655
        • Research Facility
    • New Jersey
      • Warren, New Jersey, United States, 07059
        • Research Facility
    • New York
      • Brooklyn, New York, United States, 11212
        • Research Facility
      • Johnson City, New York, United States, 13797
        • Research Facility
      • New York, New York, United States, 10029
        • Research Facility
      • New York, New York, United States, 10025
        • Research Facility
      • Rochester, New York, United States, 14621
        • Research Facility
      • Rochester, New York, United States, 14642
        • Research Facility
      • West Orange, New York, United States, 07052
        • Research Facility
      • Williamsville, New York, United States, 14221
        • Research Facility
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Research Site
      • Winston-Salem, North Carolina, United States, 27157
        • Research Facility
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Research Facility
      • Toledo, Ohio, United States, 43614
        • Research Facility
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Research Facility
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16502
        • Research Facility
      • Hershey, Pennsylvania, United States, 17033
        • Research Facility
      • Lancaster, Pennsylvania, United States, 17603
        • Research Facility
      • Philadelphia, Pennsylvania, United States, 19104
        • Research Facility
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Research Facility
      • Columbia, South Carolina, United States, 29204
        • Research Site
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Research Facility
      • Nashville, Tennessee, United States, 37203
        • Research Facility
    • Texas
      • Dallas, Texas, United States, 75226
        • Research Facility
      • Dallas, Texas, United States, 75390
        • Research Facility
      • Houston, Texas, United States, 77030
        • Research Facility
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Research Facility
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Research Facility
      • Fairfax, Virginia, United States, 22031
        • Research Facility
    • Washington
      • Spokane, Washington, United States, 99204
        • Research Facility
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54301
        • Research Facility
      • Milwaukee, Wisconsin, United States, 53215
        • Research Facility

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
125 mg azimilide
Drug: azimilide dihydrochloride
oral, once daily until sponsor stopped the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
safety of azimilide in this patient population
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Forest Laboratories

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Primary Completion (Actual)

October 1, 2005

Study Completion (Actual)

October 1, 2005

Study Registration Dates

First Submitted

September 11, 2008

First Submitted That Met QC Criteria

September 11, 2008

First Posted (Estimate)

September 12, 2008

Study Record Updates

Last Update Posted (Estimate)

February 1, 2017

Last Update Submitted That Met QC Criteria

January 31, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2001060

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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