ArrhythmiasPhase 3NCT00751738
Long Term Safety of 125 mg Per Day of Oral Azimilide in Patients With Implantable Cardioverter Defibrillator (ICDs)
A Phase 3 study testing azimilide dihydrochloride in people with Arrhythmias, run by Forest Laboratories at 86 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmias
- What is being tested?
- azimilide dihydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 86 sitesin 7 countries
- Study dates
- Oct 2002to Oct 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who completed at least 12 months on study 2000098 before inclusion in this study
Who cannot join
- breast feeding or plan to become pregnant
- used ticlopidine
- were taking Class I or other Class III drugs
Trial locations and contacts
86 sites in 7 countries.
86 sites in 7 countries
United States50 sites
Research Facility
Baltimore, Maryland, 21201
Research Facility
Baltimore, Maryland, 21204
Research Facility
Boston, Massachusetts, 02135
Research Facility
Bridgeport, Connecticut, 06610
Research Facility
Brooklyn, New York, 11212
Research Facility
Burlington, Massachusetts, 01805
Research Facility
Charleston, South Carolina, 29425
Research Facility
Charlottesville, Virginia, 22908
Research Facility
Cincinnati, Ohio, 45219
Research Facility
Colorado Springs, Colorado, 80910
Research Site
Columbia, South Carolina, 29204
Research Facility
Dallas, Texas, 75226
Research Facility
Dallas, Texas, 75390
Research Site
Durham, North Carolina, 27710
Research Facility
Erie, Pennsylvania, 16502
Research Facility
Fairfax, Virginia, 22031
Research Facility
Fort Lauderdale, Florida, 33308
Research Facility
Fort Myers, Florida, 33919
Research Facility
Germantown, Tennessee, 38138
Research Facility
Green Bay, Wisconsin, 54301
Research Facility
Hershey, Pennsylvania, 17033
Research Facility
Houston, Texas, 77030
Research Facility
Jacksonville, Florida, 32207
Research Facility
Johnson City, New York, 13797
Research Facility
Kansas City, Kansas, 66160
Research Facility
La Jolla, California, 92037
Research Facility
Lancaster, Pennsylvania, 17603
Research Facility
Little Rock, Arkansas, 72205
Research Facility
Loma Linda, California, 932354
Research Facility
Maywood, Illinois, 60153
Research Facility
Milwaukee, Wisconsin, 53215
Research Facility
Mobile, Alabama, 36608
Research Facility
Nashville, Tennessee, 37203
Research Facility
New York, New York, 10025
Research Facility
New York, New York, 10029
Research Facility
Philadelphia, Pennsylvania, 19104
Research Facility
Portland, Maine, 04102
Research Facility
Rochester, New York, 14621
Research Facility
Rochester, New York, 14642
Research Facility
Sacramento, California, 95819
Research Facility
Salt Lake City, Utah, 84132
Research Facility
Spokane, Washington, 99204
Research Facility
Toledo, Ohio, 43614
Research Facility
Tulsa, Oklahoma, 74104
Research Facility
Warren Township, New Jersey, 07059
Research Facility
Washington D.C., District of Columbia, 20010
Research Facility
West Orange, New York, 07052
Research Facility
Williamsville, New York, 14221
Research Facility
Winston-Salem, North Carolina, 27157
Research Facility
Worcester, Massachusetts, 01655
Germany12 sites
Research Facility
Bad Bevensen
Research Facility
Berlin
Research Facility
Brandenburg an der Havel
Research Facility
Coburg
Research Facility
Frankfurt
Research Facility
Freiburg im Breisgau
Research Facility
Hamburg
Research Facility
Heidelberg
Research Facility
Ludwigshafen
Research Facility
Magdeburg
Research Facility
Mannheim
Research Facility
Tübingen
Canada8 sites
Research Site
Halifax, Nova Scotia
Research Facility
Hamilton, Ontario
Research Facility
Montreal, Quebec
Research Facility
Ottawa, Ontario
Research Facility
Québec
Research Facility
St. John's, Newfoundland and Labrador
Research Facility
Toronto, Ontario
Research Facility
Victoria, British Columbia
France5 sites
Research Facility
Lille
Research Facility
Nantes
Research Facility
Paris
Research Facility
Pessac
Research Facility
Tours
Poland5 sites
Research Facility
Gdansk
Research Facility
Katowice
Research Facility
Lublin
Research Facility
Szczecin
Research Facility
Warsaw
Spain4 sites
Research Facility
Barcelona
Research Facility
Madrid
Research Facility
Málaga
Research Facility
Valencia
About this study
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
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.
- Conditions
- Arrhythmias
- Being tested
- azimilide dihydrochloride
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
azimilide dihydrochlorideDrug
oral, once daily until sponsor stopped the study
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 125 mg azimilide Receives: Drug: azimilide dihydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety of azimilide in this patient population
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2008 (estimated)
- Study startOct 2002
- Primary completionOct 2005
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArrhythmiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forest Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jose M Brum, MD, Study director, Procter and Gamble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00751738
- Sponsor's protocol ID
- 2001060
- Status last verified
- Jan 2017
- First submitted
- 11 Sep 2008
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00751738
- Acronym / sponsor ID
- 2001060
- Conditions
- Arrhythmias
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Forest LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Oct 2002
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 12 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: azimilide dihydrochloride125 mg azimilide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients who completed at least 12 months on study 2000098 before inclusion in this study
Key exclusion criteria (3 listed)
- breast feeding or plan to become pregnant
- used ticlopidine
- were taking Class I or other Class III drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| azimilide dihydrochlorideoral, once daily until sponsor stopped the study | Drug | 1 |
Primary outcome
safety of azimilide in this patient population
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
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Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
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VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
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EDEN Intracardiac Electrogram Recording and Classifying System
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose M Brum, MD study director
Procter and Gamble
86 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing azimilide dihydrochloride in people with Arrhythmias, run by Forest Laboratories at 86 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 86 sites in United States, Germany, Canada, France, Poland and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety of azimilide in this patient population (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2017.