Atrial FibrillationPhase 4AFRODITENCT01047566
Effect of Addition of Dronedarone to Standard Rate Control Therapy on Ventricular Rate During Persistent Atrial Fibrillation (AFRODITE)
A Phase 4 study testing Dronedarone and Beta blocker or calcium antagonist or digoxin in people with Atrial Fibrillation, run by Sanofi at 1 site in Netherlands.
Trial summary
The primary objective of this study is to: Assess whether the addition of dronedarone to existing conventional rate control therapy leads to a reduced ventricular rate after 1 week in patients with a high Heart Rate (HR) at rest during Atrial Fibrillation (AF) in comparison to an increase of conventional therapy. Read more about this study
- Who is it for?
- Ages 46 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Dronedarone and Beta blocker or calcium antagonist or digoxin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2010to Sep 2011
- Phase
- Phase 4
- 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 46 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Persistent AF with HR >80 bpm at rest despite treatment with ≤ 2 rate control agents (i.e. beta blocker and/or calcium antagonist - Patients using digoxin are eligible)
- Documented AF in the past 24 hours
- Treated with the following rate control medication:
- beta blocker or
- calcium antagonist or
- beta blocker plus calcium antagonist or
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- beta blocker plus digoxin or
- calcium antagonist plus digoxin
- Anticoagulant treatment in line with local guidelines
Who cannot join
- Incapacitated patients
- Paroxysmal or permanent AF
- Use of class I or III anti-arrhythmic drugs in the past 12 weeks
- Scheduled cardioversion or pulmonary vein ablation
- Unstable New York Heart Association (NYHA) class III and all class IV Heart Failure
- AV block grade 2 or 3
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- Known severe renal impairment (serum creatinine > 180 μmol/l)
- Known severe hepatic impairment (AST, ALT > 3 x Upper Limit of Normal (ULN))
- Contra-indication for dronedarone
- Participation in a clinical drug study in the 3 months prior to inclusion
- Women of childbearing potential, who do not use adequate contraception
- Lactating women
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of the Addition of Dronedarone to, Versus Increase of, Existing Conventional Rate Control Medication on Ventricular Rate During Persistent Atrial Fibrillation
The primary objective of this study is to:
Assess whether the addition of dronedarone to existing conventional rate control therapy leads to a reduced ventricular rate after 1 week in patients with a high Heart Rate (HR) at rest during Atrial Fibrillation (AF) in comparison to an increase of conventional therapy.
The secondary objectives of this study are to compare both study arms with regard to:
- Ventricular rate after 3 months
- Number of registered AF episodes
- Number of symptomatic AF episodes
- Severity of AF and AF-like symptoms
- Rate of premature study discontinuation
- Number of symptomatic episodes of bradycardia
- Incidence of low heart rate (<60 bpm)
- Conditions
- Atrial Fibrillation
- Being tested
- Dronedarone, Beta blocker or calcium antagonist or digoxin
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DronedaroneDrug
Also called Multaq
Pharmaceutical form: tablet Route of administration: oral Dose regimen: 400 mg twice daily for 12 weeks (+/- 5 days)
Beta blocker or calcium antagonist or digoxinDrug
Dose increase of beta blocker or calcium antagonist or digoxin
| Study group | Role | What they receive |
|---|---|---|
| Addition of dronedarone | Experimental | Addition of Dronedarone to existing rate control medication (beta blocker and/or calcium antagonist) Receives: Drug: Dronedarone |
| Dose Increase | Active comparator | Dose increase of existing rate control medication (beta blocker or calcium antagonist or digoxin) Receives: Drug: Beta blocker or calcium antagonist or digoxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventricular rate
Measured: One week
Secondary outcomes (7)
Ventricular rate
Measured: 12 weeks
Patients with registered AF episodes
Measured: Within the 12 weeks after randomization
Patients with symptomatic AF episodes
Measured: Within the 12 weeks after randomization
Severity of AF and AF-like symptoms
Measured: Within the 12 weeks after randomization
Premature study discontinuation
Premature study discontinuation for all reasons including those where the patients must go off study prematurely as per protocol (ie. in case of cardioversion during the 1st study week, 2nd cardioversion after the 1st study week, addition of anti-arrhythmic drug, ablation or other surgical AF related intervention)
Measured: Within the 12 weeks after randomization
Patients with symptomatic episodes of bradycardia
Measured: Within the 12 weeks after randomization
Patients with low heart rate (<60 bpm)
Measured: Within the 12 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2010 (estimated)
- Study startApr 2010
- Primary completionSep 2011
- Study completionSep 2011
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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01047566
- Sponsor's protocol ID
- DRONE_L_05066
- Other IDs
- 2009-018215-53, 2009
- Acronym
- AFRODITE
- Status last verified
- Nov 2011
- First submitted
- 12 Jan 2010
- Last updated
- 10 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Addition of Dronedarone to, Versus Increase of, Existing Conventional Rate Control Medication on Ventricular Rate During Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT01047566
- Acronym / sponsor ID
- AFRODITE / DRONE_L_05066
- Conditions
- Atrial Fibrillation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 13 Jan 2010 (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 primary objective of this study is to:
Assess whether the addition of dronedarone to existing conventional rate control therapy leads to a reduced ventricular rate after 1 week in patients with a high Heart Rate (HR) at rest during Atrial Fibrillation (AF) in comparison to an increase of conventional therapy.
The secondary objectives of this study are to compare both study arms with regard to:
- Ventricular rate after 3 months
- Number of registered AF episodes
- Number of symptomatic AF episodes
- Severity of AF and AF-like symptoms
- Rate of premature study discontinuation
- Number of symptomatic episodes of bradycardia
- Incidence of low heart rate (<60 bpm)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Addition of dronedarone | Experimental | Drug: DronedaroneAddition of Dronedarone to existing rate control medication (beta blocker and/or calcium antagonist) |
| Dose Increase | Active comparator | Drug: Beta blocker or calcium antagonist or digoxinDose increase of existing rate control medication (beta blocker or calcium antagonist or digoxin) |
Who may qualify
- Ages
- 46 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Persistent AF with HR >80 bpm at rest despite treatment with ≤ 2 rate control agents (i.e. beta blocker and/or calcium antagonist - Patients using digoxin are eligible)
- Documented AF in the past 24 hours
- Treated with the following rate control medication:
- beta blocker or
- calcium antagonist or
Key exclusion criteria (13 listed)
- Incapacitated patients
- Paroxysmal or permanent AF
- Use of class I or III anti-arrhythmic drugs in the past 12 weeks
- Scheduled cardioversion or pulmonary vein ablation
- Unstable New York Heart Association (NYHA) class III and all class IV Heart Failure
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 |
|---|---|---|
| DronedaroneAlso: MultaqPharmaceutical form: tablet Route of administration: oral Dose regimen: 400 mg twice daily for 12 weeks (+/- 5 days) | Drug | Addition of dronedarone |
| Beta blocker or calcium antagonist or digoxinDose increase of beta blocker or calcium antagonist or digoxin | Drug | Dose Increase |
Primary outcome
Ventricular rate
Time frame: One week
7 secondary outcomes
Ventricular rate
Time frame: 12 weeks
Patients with registered AF episodes
Time frame: Within the 12 weeks after randomization
Patients with symptomatic AF episodes
Time frame: Within the 12 weeks after randomization
Severity of AF and AF-like symptoms
Time frame: Within the 12 weeks after randomization
Premature study discontinuation
Time frame: Within the 12 weeks after randomization
Patients with symptomatic episodes of bradycardia
Time frame: Within the 12 weeks after randomization
Patients with low heart rate (<60 bpm)
Time frame: Within the 12 weeks after randomization
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 10 Nov 2011.
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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.
Clinical Sciences & Operations study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dronedarone and Beta blocker or calcium antagonist or digoxin in people with Atrial Fibrillation, run by Sanofi at 1 site in Netherlands.
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 9 inclusion and 13 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 10 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Ventricular rate (time frame: One week). 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 10 Nov 2011.