Atrial FibrillationPhase 3DIONYSOSNCT00489736
Efficacy & Safety of Dronedarone Versus Amiodarone for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation
A Phase 3 study testing dronedarone (SR33589) and amiodarone in people with Atrial Fibrillation, run by Sanofi at 23 sites in 23 countries.
Trial summary
The objective of this study is to compare the efficacy and safety of dronedarone to that of amiodarone for the treatment of patients with atrial fibrillation. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- dronedarone (SR33589) and amiodarone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 504 participants
- Where
- 23 sitesin 23 countries
- Study dates
- Jun 2007to Oct 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with documented atrial fibrillation for more than 72 hours for whom cardioversion and antiarrhythmic treatment is indicated in the opinion of the investigator and under oral anticoagulation
Who cannot join
- Contraindication to oral anticoagulation
- Patient having received amiodarone in the past whatever the date (more than a total of twenty 200 mg tablets or more than 5 days intravenous)
- Patients known to have chronic AF, patients with atrial flutter or paroxysmal atrial fibrillation
- Severe congestive heart failure with New-York Heart Association (NYHA) class III or IV, severe bradycardia, high degree atrio-ventricular block, ongoing potentially dangerous symptoms when in AF such as angina pectoris, transient ischemic attacks, stroke, syncope, as judged by the investigator, first degree family history of sudden cardiac death below age 50 years in the absence of coronary heart disease, significant sinus node disease without a permanent pacemaker implanted
- History of torsades de pointes or long QT syndrome or QT- or QTc-interval ≥500 msecs before randomization
- Treatment with other class I or III antiarrhythmic drugs which cannot be discontinued
- Dysthyroidism or other contraindication to amiodarone
- The above information are not intended to contain all the considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
23 sites in 23 countries.
23 sites in 23 countries
United States1 site
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807
About this study
Official title: Randomized Double Blind Trial to Evaluate the Efficacy and Safety of Dronedarone (400mg BID) Versus Amiodarone (600mg Daily for 28 Days, Then 200mg Daily Thereafter) for at Least 6 Months for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation (AF)
The objective of this study is to compare the efficacy and safety of dronedarone to that of amiodarone for the treatment of patients with atrial fibrillation.
- Conditions
- Atrial Fibrillation
- Being tested
- dronedarone (SR33589), amiodarone
- Keywords
- Atrial Fibrillation, sinus rhythm, amiodarone
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dronedarone (SR33589)Drug
Also called Multaq®
oral administration
amiodaroneDrug
oral administration
| Study group | Role | What they receive |
|---|---|---|
| Dronedarone 400mg bid | Experimental | dronedarone 400mg tablets administered twice a day (bid) and matching over-encapsulated tablets of placebo of amiodarone 200mg Receives: Drug: dronedarone (SR33589) |
| Amiodarone 600mg/200mg od | Active comparator | over-encapsulated tablets of amiodarone 200mg (600mg daily for 28 days then 200mg daily) administered once daily (od) and matching placebo of dronedarone 400mg tablets Receives: Drug: amiodarone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Failure
The primary event is the treatment failure defined as the first recurrence of atrial fibrillation or premature study drug discontinuation for intolerance or lack of efficacy according to the investigator judgement. The primary efficacy analysis is performed on the time from first study drug intake to this primary event. The "Measured Values" table below presents the numbers of patients with the event at the end of the study period.
Measured: minimum study duration is 6 months (+10 days); maximum is 15 months
Secondary outcomes (1)
Occurrence of the Main Safety Endpoint (MSE) Defined as Thyroid, Hepatic, Pulmonary, Neurological, Skin, Eye, or Gastrointestinal Specific Treatment Emergent Events or Premature Study Drug Discontinuation Following Any Adverse Event
The considered event is the occurrence of the MSE defined as thyroid, hepatic, pulmonary, neurological, skin, eye, or gastrointestinal specific treatment emergent events or premature study drug discontinuation following any adverse event (AE), whichever comes first. The analysis is performed on the time from first study drug intake to this event. The "Measured Values" table below presents the numbers of patients with the event at the end of the study period.
Measured: minimum study duration is 6 months (+10 days); maximum is 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2007 (estimated)
- Study startJun 2007
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 504 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- International Clinical Development, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00489736
- Sponsor's protocol ID
- EFC4968
- Acronym
- DIONYSOS
- Status last verified
- Feb 2010
- First submitted
- 20 Jun 2007
- Last updated
- 18 Feb 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Le Heuzey JY, De Ferrari GM, Radzik D, Santini M, Zhu J, Davy JM. A short-term, randomized, double-blind, parallel-group study to evaluate the efficacy and safety of dronedarone versus amiodarone in patients with persistent atrial fibrillation: the DIONYSOS study. J Cardiovasc Electrophysiol. 2010 Jun 1;21(6):597-605. doi: 10.1111/j.1540-8167.2010.01764.x. Epub 2010 Apr 6.
PubMed 20384650Ezekowitz MD. Maintaining sinus rhythm--making treatment better than the disease. N Engl J Med. 2007 Sep 6;357(10):1039-41. doi: 10.1056/NEJMe078148. No abstract available.
PubMed 17804851
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double Blind Trial to Evaluate the Efficacy and Safety of Dronedarone (400mg BID) Versus Amiodarone (600mg Daily for 28 Days, Then 200mg Daily Thereafter) for at Least 6 Months for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation (AF)
- ClinicalTrials.gov ID
- NCT00489736
- Acronym / sponsor ID
- DIONYSOS / EFC4968
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation, sinus rhythm, amiodarone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 504 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 21 Jun 2007 (estimated)
- Results
- Posted 9 Nov 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to compare the efficacy and safety of dronedarone to that of amiodarone for the treatment of patients with atrial fibrillation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dronedarone 400mg bid | Experimental | Drug: dronedarone (SR33589)dronedarone 400mg tablets administered twice a day (bid) and matching over-encapsulated tablets of placebo of amiodarone 200mg |
| Amiodarone 600mg/200mg od | Active comparator | Drug: amiodaroneover-encapsulated tablets of amiodarone 200mg (600mg daily for 28 days then 200mg daily) administered once daily (od) and matching placebo of dronedarone 400mg tablets |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with documented atrial fibrillation for more than 72 hours for whom cardioversion and antiarrhythmic treatment is indicated in the opinion of the investigator and under oral anticoagulation
Key exclusion criteria (8 listed)
- Contraindication to oral anticoagulation
- Patient having received amiodarone in the past whatever the date (more than a total of twenty 200 mg tablets or more than 5 days intravenous)
- Patients known to have chronic AF, patients with atrial flutter or paroxysmal atrial fibrillation
- Severe congestive heart failure with New-York Heart Association (NYHA) class III or IV, severe bradycardia, high degree atrio-ventricular block, ongoing potentially dangerous symptoms when in AF such as angina pectoris, transient ischemic attacks, stroke, syncope, as judged by the investigator, first degree family history of sudden cardiac death below age 50 years in the absence of coronary heart disease, significant sinus node disease without a permanent pacemaker implanted
- History of torsades de pointes or long QT syndrome or QT- or QTc-interval ≥500 msecs before randomization
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 |
|---|---|---|
| dronedarone (SR33589)Also: Multaq®oral administration | Drug | Dronedarone 400mg bid |
| amiodaroneoral administration | Drug | Amiodarone 600mg/200mg od |
Primary outcome
Treatment Failure
Time frame: minimum study duration is 6 months (+10 days); maximum is 15 months
The primary event is the treatment failure defined as the first recurrence of atrial fibrillation or premature study drug discontinuation for intolerance or lack of efficacy according to the investigator judgement. The primary efficacy analysis is performed on the time from first study drug intake to this primary event. The "Measured Values" table below presents the numbers of patients with the event at the end of the study period.
1 secondary outcome
Occurrence of the Main Safety Endpoint (MSE) Defined as Thyroid, Hepatic, Pulmonary, Neurological, Skin, Eye, or Gastrointestinal Specific Treatment Emergent Events or Premature Study Drug Discontinuation Following Any Adverse Event
Time frame: minimum study duration is 6 months (+10 days); maximum is 15 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20384650Le Heuzey JY, De Ferrari GM, Radzik D, Santini M, Zhu J, Davy JM. A short-term, randomized, double-blind, parallel-group study to evaluate the efficacy and safety of dronedarone versus amiodarone in patients with persistent atrial fibrillation: the DIONYSOS study. J Cardiovasc Electrophysiol. 2010 Jun 1;21(6):597-605. doi: 10.1111/j.1540-8167.2010.01764.x. Epub 2010 Apr 6.
- Derived from this study: PubMed 17804851Ezekowitz MD. Maintaining sinus rhythm--making treatment better than the disease. N Engl J Med. 2007 Sep 6;357(10):1039-41. doi: 10.1056/NEJMe078148. No abstract available.
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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.
International Clinical Development study director
Sanofi
23 sites in 23 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing dronedarone (SR33589) and amiodarone in people with Atrial Fibrillation, run by Sanofi at 23 sites in 23 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 8 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 18 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Argentina, Australia, Austria, Belgium and 18 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?
Yes. Results are posted in the registry (first posted 9 Nov 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Treatment Failure (time frame: minimum study duration is 6 months (+10 days); maximum is 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00489736, which also lists 2 linked publications.
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 18 Feb 2010.