NCT00751738

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
330

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2002

Typical duration for phase_3

Geographic Reach
7 countries

86 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 12, 2008

Completed
Last Updated

February 1, 2017

Status Verified

January 1, 2017

Enrollment Period

3 years

First QC Date

September 11, 2008

Last Update Submit

January 31, 2017

Conditions

Arrhythmias

Outcome Measures

Primary Outcomes (1)

  • safety of azimilide in this patient population

    1 year

Study Arms (1)

1

EXPERIMENTAL

125 mg azimilide

Drug: azimilide dihydrochloride

Interventions

azimilide dihydrochlorideDRUG

oral, once daily until sponsor stopped the study

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (86)

Research Facility

Mobile, Alabama, 36608, United States

Location

Research Facility

Little Rock, Arkansas, 72205, United States

Location

Research Facility

La Jolla, California, 92037, United States

Location

Research Facility

Loma Linda, California, 932354, United States

Location

Research Facility

Sacramento, California, 95819, United States

Location

Research Facility

Colorado Springs, Colorado, 80910, United States

Location

Research Facility

Bridgeport, Connecticut, 06610, United States

Location

Research Facility

Washington D.C., District of Columbia, 20010, United States

Location

Research Facility

Fort Lauderdale, Florida, 33308, United States

Location

Research Facility

Fort Myers, Florida, 33919, United States

Location

Research Facility

Jacksonville, Florida, 32207, United States

Location

Research Facility

Maywood, Illinois, 60153, United States

Location

Research Facility

Kansas City, Kansas, 66160, United States

Location

Research Facility

Portland, Maine, 04102, United States

Location

Research Facility

Baltimore, Maryland, 21201, United States

Location

Research Facility

Baltimore, Maryland, 21204, United States

Location

Research Facility

Boston, Massachusetts, 02135, United States

Location

Research Facility

Burlington, Massachusetts, 01805, United States

Location

Research Facility

Worcester, Massachusetts, 01655, United States

Location

Research Facility

Warren Township, New Jersey, 07059, United States

Location

Research Facility

Brooklyn, New York, 11212, United States

Location

Research Facility

Johnson City, New York, 13797, United States

Location

Research Facility

New York, New York, 10025, United States

Location

Research Facility

New York, New York, 10029, United States

Location

Research Facility

Rochester, New York, 14621, United States

Location

Research Facility

Rochester, New York, 14642, United States

Location

Research Facility

West Orange, New York, 07052, United States

Location

Research Facility

Williamsville, New York, 14221, United States

Location

Research Site

Durham, North Carolina, 27710, United States

Location

Research Facility

Winston-Salem, North Carolina, 27157, United States

Location

Research Facility

Cincinnati, Ohio, 45219, United States

Location

Research Facility

Toledo, Ohio, 43614, United States

Location

Research Facility

Tulsa, Oklahoma, 74104, United States

Location

Research Facility

Erie, Pennsylvania, 16502, United States

Location

Research Facility

Hershey, Pennsylvania, 17033, United States

Location

Research Facility

Lancaster, Pennsylvania, 17603, United States

Location

Research Facility

Philadelphia, Pennsylvania, 19104, United States

Location

Research Facility

Charleston, South Carolina, 29425, United States

Location

Research Site

Columbia, South Carolina, 29204, United States

Location

Research Facility

Germantown, Tennessee, 38138, United States

Location

Research Facility

Nashville, Tennessee, 37203, United States

Location

Research Facility

Dallas, Texas, 75226, United States

Location

Research Facility

Dallas, Texas, 75390, United States

Location

Research Facility

Houston, Texas, 77030, United States

Location

Research Facility

Salt Lake City, Utah, 84132, United States

Location

Research Facility

Charlottesville, Virginia, 22908, United States

Location

Research Facility

Fairfax, Virginia, 22031, United States

Location

Research Facility

Spokane, Washington, 99204, United States

Location

Research Facility

Green Bay, Wisconsin, 54301, United States

Location

Research Facility

Milwaukee, Wisconsin, 53215, United States

Location

Research Facility

Bruges, Belgium

Location

Research Facility

Mont Godinne, Belgium

Location

Research Facility

Victoria, British Columbia, Canada

Location

Research Facility

St. John's, Newfoundland and Labrador, Canada

Location

Research Site

Halifax, Nova Scotia, Canada

Location

Research Facility

Hamilton, Ontario, Canada

Location

Research Facility

Ottawa, Ontario, Canada

Location

Research Facility

Toronto, Ontario, Canada

Location

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Montreal, Quebec, Canada

Location

Research Facility

Québec, Canada

Location

Research Facility

Lille, France

Location

Research Facility

Nantes, France

Location

Research Facility

Paris, France

Location

Research Facility

Pessac, France

Location

Research Facility

Tours, France

Location

Research Facility

Bad Bevensen, Germany

Location

Research Facility

Berlin, Germany

Location

Research Facility

Brandenburg, Germany

Location

Research Facility

Coburg, Germany

Location

Research Facility

Frankfurt, Germany

Location

Research Facility

Freiburg im Breisgau, Germany

Location

Research Facility

Hamburg, Germany

Location

Research Facility

Heidelberg, Germany

Location

Research Facility

Ludwigshafen, Germany

Location

Research Facility

Magdeburg, Germany

Location

Research Facility

Mannheim, Germany

Location

Research Facility

Tübingen, Germany

Location

Research Facility

Gdansk, Poland

Location

Research Facility

Katowice, Poland

Location

Research Facility

Lublin, Poland

Location

Research Facility

Szczecin, Poland

Location

Research Facility

Warsaw, Poland

Location

Research Facility

Barcelona, Spain

Location

Research Facility

Madrid, Spain

Location

Research Facility

Málaga, Spain

Location

Research Facility

Valencia, Spain

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Interventions

azimilide

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jose M Brum, MD

    Procter and Gamble

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 11, 2008

First Posted

September 12, 2008

Study Start

October 1, 2002

Primary Completion

October 1, 2005

Study Completion

October 1, 2005

Last Updated

February 1, 2017

Record last verified: 2017-01

Locations

CA(8)FR(5)PL(5)ES(4)DE(12)US(50)BE(2)