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

NCT ID: NCT00751738

Last Updated: 2017-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2005-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Arrhythmias

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

125 mg azimilide

Group Type EXPERIMENTAL

azimilide dihydrochloride

Intervention Type DRUG

oral, once daily until sponsor stopped the study

Interventions

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azimilide dihydrochloride

oral, once daily until sponsor stopped the study

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Forest Laboratories

INDUSTRY

Sponsor Role lead

Responsible Party

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Procter and Gamble Pharmaceuticals

Principal Investigators

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Jose M Brum, MD

Role: STUDY_DIRECTOR

Procter and Gamble

Locations

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Mobile, Alabama, United States

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Little Rock, Arkansas, United States

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La Jolla, California, United States

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Loma Linda, California, United States

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Sacramento, California, United States

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Colorado Springs, Colorado, United States

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Bridgeport, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Fort Lauderdale, Florida, United States

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Fort Myers, Florida, United States

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Jacksonville, Florida, United States

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Maywood, Illinois, United States

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Kansas City, Kansas, United States

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Portland, Maine, United States

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Baltimore, Maryland, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Burlington, Massachusetts, United States

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Worcester, Massachusetts, United States

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Warren Township, New Jersey, United States

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Brooklyn, New York, United States

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Johnson City, New York, United States

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New York, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Rochester, New York, United States

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West Orange, New York, United States

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Williamsville, New York, United States

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Durham, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Toledo, Ohio, United States

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Tulsa, Oklahoma, United States

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Erie, Pennsylvania, United States

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Hershey, Pennsylvania, United States

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Lancaster, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Charleston, South Carolina, United States

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Columbia, South Carolina, United States

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Germantown, Tennessee, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Salt Lake City, Utah, United States

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Charlottesville, Virginia, United States

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Fairfax, Virginia, United States

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Spokane, Washington, United States

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Green Bay, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Bruges, , Belgium

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Mont Godinne, , Belgium

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Victoria, British Columbia, Canada

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St. John's, Newfoundland and Labrador, Canada

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Halifax, Nova Scotia, Canada

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Hamilton, Ontario, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Québec, , Canada

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Lille, , France

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Nantes, , France

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Paris, , France

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Pessac, , France

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Tours, , France

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Bad Bevensen, , Germany

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Berlin, , Germany

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Brandenburg, , Germany

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Coburg, , Germany

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Frankfurt, , Germany

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Freiburg im Breisgau, , Germany

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Hamburg, , Germany

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Heidelberg, , Germany

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Ludwigshafen, , Germany

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Magdeburg, , Germany

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Mannheim, , Germany

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Tübingen, , Germany

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Gdansk, , Poland

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Katowice, , Poland

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Lublin, , Poland

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Szczecin, , Poland

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Warsaw, , Poland

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Barcelona, , Spain

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Madrid, , Spain

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Málaga, , Spain

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Valencia, , Spain

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Countries

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United States Belgium Canada France Germany Poland Spain

Other Identifiers

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2001060

Identifier Type: -

Identifier Source: org_study_id

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