Atrial FibrillationPhase 2NCT00389792
Efficacy and Safety Study of an Antiarrhythmic Drug to Treat Atrial Fibrillation in Patients With Pacemakers
A Phase 2 study testing ATI-2042 and ATI-2042 200 mg in people with Atrial Fibrillation, run by ARYx Therapeutics at 40 sites in 2 countries.
Trial summary
The purpose of this study is to determine the safety and efficacy of an investigational antiarrhythmic drug (ATI-2042) in the treatment of atrial fibrillation in patients with a dual chamber pacemaker. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- ATI-2042 and ATI-2042 200 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 40 sitesin 2 countries
- Study dates
- Jul 2006to Dec 2008
- Phase
- Phase 2
- 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
- Proven paroxysmal atrial fibrillation
- Pacemaker with appropriate AF diagnostics and recording capabilities
Who cannot join
- Known allergy to Amiodarone or previous treatment for severe Amiodarone toxicity
- Cardioversion within one month of screening
- Severe left ventricular dysfunction or CHF with NYHA Class III or above
Trial locations and contacts
40 sites in 2 countries.
40 sites in 2 countries
United States27 sites
ARYx Investigational Site
Albuquerque, New Mexico, 87102
ARYx Investigational Site
Atlanta, Georgia, 30309
ARYx Investigational Site
Aurora, Colorado, 80012
ARYx Investigational Site
Austin, Texas, 78756
ARYx Investigational Site
Buffalo, New York, 14215
ARYx Investigational Site
Burlington, Vermont, 05401
ARYx Investigational Site
Charleston, South Carolina, 29425
ARYx Investigational Site
Charleston, West Virginia, 25304
ARYx Investigational Site
Chicago, Illinois, 60611
ARYx Investigational Site
Hershey, Pennsylvania, 17033
ARYx Investigational Site
Hollywood, Florida, 33021
ARYx Investigational Site
Houston, Texas, 77030
ARYx Investigational Site
Jacksonville Beach, Florida, 32250
ARYx Investigational Site
Larkspur, California, 94939
ARYx Investigational Site
Lincoln, Nebraska, 68506
ARYx Investigational Site
Marietta, Georgia, 30060
ARYx Investigational Site
Minneapolis, Minnesota, 55442
ARYx Investigational Site
Nashville, Tennessee, 37203
ARYx Investigational Site
Newport News, Virginia, 23601
ARYx Investigational Site
Phoenix, Arizona, 85306
ARYx Investigational Site
Saginaw, Michigan, 48601
ARYx Investigational Site
Scottsdale, Arizona, 85251
ARYx Investigational Site
St Louis, Missouri, 63110
ARYx Investigational Site
Towson, Maryland, 21204
ARYx Investigational Site
Tucson, Arizona, 85715
ARYx Investigational Site
Warren Township, New Jersey, 07059
ARYx Investigational Site
Wynnewood, Pennsylvania, 19096
Canada13 sites
ARYx Investigational Site
Campbell River, British Columbia, V9W3V1
ARYx Investigational Site
Edmonton, Alberta, T6G 2B7
ARYx Investigational Site
Edmonton, Alberta, T6K4C1
ARYx Investigational Site
London, Ontario, N6A 5A5
ARYx Investigational Site
Montreal, Quebec, H1T 1C8
ARYx Investigational Site
Montreal, Quebec, H2L 4M1
ARYx Investigational Sites
Montreal, Quebec, H4J1C5
ARYx Investigational Site
Niagara Falls, Ontario, L2E 7H1
ARYx Investigational Site
Ottawa, Ontario, K1Y 4W7
ARYx Investigational Site
Sherbrooke, Quebec, J1H5N4
ARYx Investigational Site
Terrebonne, Quebec, J6V 2H2
ARYx Investigational Site
Vancouver, British Columbia, V6Z1Y6
ARYx Investigational Site
Victoria, British Columbia, V8R 4R2
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of ATI-2042 in Patients With Paroxysmal Atrial Fibrillation and Pacemakers With Atrial Fibrillation Data Logging Capabilities
The purpose of this study is to determine the safety and efficacy of an investigational antiarrhythmic drug (ATI-2042) in the treatment of atrial fibrillation in patients with a dual chamber pacemaker.
Read the detailed description
ATI-2042 is being developed as an alternative to amiodarone, which is considered a first-line therapy for patients with atrial fibrillation and is known to have serious side effects. ATI-2042 was designed to have a reduced plasma half-life and a lower volume of distribution, which is expected to result in an improved safety profile. In contrast to amiodarone, ATI-2042 undergoes rapid metabolism via plasma and tissue esterases, which may reduce tissue accumulation and toxicity. The current trial will determine if ATI-2042 retains the efficacy profile of amiodarone without the side effects attributable to tissue accumulation seen with long-term dosing.
This study is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants.)
- Conditions
- Atrial Fibrillation
- Being tested
- ATI-2042, ATI-2042 200 mg
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATI-2042Drug
no intervention
ATI-2042 200 mgDrug
To stop the dosing of ATI-2042 for a designated time frame as determined by the medical monitor and Principal Investigator.
| Study group | Role | What they receive |
|---|---|---|
| ATI-2042 200 mg | No intervention | Not described Receives: Drug: ATI-2042; Drug: ATI-2042 200 mg |
| ATI-2042 400 mg | No intervention | Not described Receives: Drug: ATI-2042; Drug: ATI-2042 200 mg |
| ATI-2042 600 mg | No intervention | Not described Receives: Drug: ATI-2042; Drug: ATI-2042 200 mg |
| ATI-2042 Placebo | No intervention | Not described Receives: Drug: ATI-2042; Drug: ATI-2042 200 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy Measure: Atrial Fibrillation Burden
Safety Measures: ECG, Laboratory and Adverse Events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2006 (estimated)
- Study startJul 2006
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- ARYx Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Michael Ezekowitz, MBChB, PhD, Study chair, Main Line HealthOlga Bandman, MD, Study director, ARYx Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00389792
- Sponsor's protocol ID
- ATI 2042-CLN 205
- Status last verified
- Mar 2009
- First submitted
- 17 Oct 2006
- Last updated
- 11 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study of ATI-2042 in Patients With Paroxysmal Atrial Fibrillation and Pacemakers With Atrial Fibrillation Data Logging Capabilities
- ClinicalTrials.gov ID
- NCT00389792
- Acronym / sponsor ID
- ATI 2042-CLN 205
- Conditions
- Atrial Fibrillation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- ARYx TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 19 Oct 2006 (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.
The purpose of this study is to determine the safety and efficacy of an investigational antiarrhythmic drug (ATI-2042) in the treatment of atrial fibrillation in patients with a dual chamber pacemaker.
Detailed description
ATI-2042 is being developed as an alternative to amiodarone, which is considered a first-line therapy for patients with atrial fibrillation and is known to have serious side effects. ATI-2042 was designed to have a reduced plasma half-life and a lower volume of distribution, which is expected to result in an improved safety profile. In contrast to amiodarone, ATI-2042 undergoes rapid metabolism via plasma and tissue esterases, which may reduce tissue accumulation and toxicity. The current trial will determine if ATI-2042 retains the efficacy profile of amiodarone without the side effects attributable to tissue accumulation seen with long-term dosing.
This study is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants.)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ATI-2042 200 mg | No intervention | Drug: ATI-2042, Drug: ATI-2042 200 mg |
| ATI-2042 400 mg | No intervention | Drug: ATI-2042, Drug: ATI-2042 200 mg |
| ATI-2042 600 mg | No intervention | Drug: ATI-2042, Drug: ATI-2042 200 mg |
| ATI-2042 Placebo | No intervention | Drug: ATI-2042, Drug: ATI-2042 200 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Proven paroxysmal atrial fibrillation
- Pacemaker with appropriate AF diagnostics and recording capabilities
Key exclusion criteria (3 listed)
- Known allergy to Amiodarone or previous treatment for severe Amiodarone toxicity
- Cardioversion within one month of screening
- Severe left ventricular dysfunction or CHF with NYHA Class III or above
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 |
|---|---|---|
| ATI-2042no intervention | Drug | ATI-2042 200 mg, ATI-2042 400 mg, ATI-2042 600 mg, ATI-2042 Placebo |
| ATI-2042 200 mgTo stop the dosing of ATI-2042 for a designated time frame as determined by the medical monitor and Principal Investigator. | Drug | ATI-2042 200 mg, ATI-2042 400 mg, ATI-2042 600 mg, ATI-2042 Placebo |
Primary outcome
Efficacy Measure: Atrial Fibrillation Burden
Safety Measures: ECG, Laboratory and Adverse Events
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 11 Mar 2009.
Related trials for Atrial Fibrillation
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Paroxysmal AF
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Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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CONVERGE Post-Approval Study (PAS)
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Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
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Atrial Fibrillation (AF)
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.
Michael Ezekowitz, MBChB, PhD study chair
Main Line Health
Olga Bandman, MD study director
ARYx Therapeutics
40 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ATI-2042 and ATI-2042 200 mg in people with Atrial Fibrillation, run by ARYx Therapeutics at 40 sites in 2 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 2 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 11 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States, Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Efficacy Measure: Atrial Fibrillation Burden. The study lists 2 primary outcomes in all. 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 11 Mar 2009.