Atrial FibrillationPhase 2NCT01213368
Dose Ranging Study of Dronedarone for the Control of Ventricular Rate in Japanese Patients With Permanent Atrial Fibrillation
A Phase 2 study testing DRONEDARONE (SR33589) in people with Atrial Fibrillation, run by Sanofi at 25 sites in Japan.
Trial summary
Primary Objective: To assess the efficacy of dronedarone versus placebo for the control of ventricular rate in patients with permanent Atrial Fibrillation (AF). Secondary Objective: To assess the safety and tolerability of dronedarone after repeated oral doses of 300 mg, 400 mg, or 600 mg twice daily in the selected… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- DRONEDARONE (SR33589)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 181 participants
- Where
- 25 sitesJapan
- Study dates
- Sep 2010to Apr 2011
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of aged 20 years or more.
- Permanent Atrial Fibrillation [AF] (defined as duration of AF > 6 months) for which cardioversion is not considered and with resting ventricular heart rate ≥ 80 bpm at screening.
Who cannot join
- Unstable angina pectoris.
- History of torsades de pointes.
- Prolonged QT corrected interval (≥ 500 ms).
- Third degree atrioventricular block (AVB) on the screening ECG while in AF or, documentation on previous ECGs while in sinus rhythm of PR-interval > 0.28 sec or high degree AVB (2nd degree or higher) or, significant sinus node disease (documented pause ≥ 3 sec) - without a permanent pacemaker implanted.
- Congestive Heart Failure (CHF) of New York Heart Association classification (NYHA) class IV or recent (within 1 month prior to randomization) unstable NYHA class III.
- Treatment with other class I or III anti-arrhythmic drugs.
Show all 10Show fewer
- Patients treated with amiodarone during the 4 weeks preceding randomization.
- Clinically relevant haematologic, hepatic, gastro-intestinal, renal, pulmonary, endocrinologic (in particular thyroid) or psychiatric disease.
- Hypokalemia and hypomagnesemia must be corrected before randomization.
- 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
25 sites in 1 country.
25 sites in 1 country
Japan25 sites
Investigational Site Number 392022
Hiroshima
Investigational Site Number 392018
Kagoshima
Investigational Site Number 392005
Kasama-Shi
Investigational Site Number 392014
Kawanishi-Shi
Investigational Site Number 392008
Kawasaki-Shi
Investigational Site Number 392007
Kisarazu-Shi
Investigational Site Number 392012
Kobe
Investigational Site Number 392013
Kobe
Investigational Site Number 392003
Koriyama-Shi
Investigational Site Number 392017
Kurume-Shi
Investigational Site Number 392023
Miyazaki
Investigational Site Number 392009
Nagano
Investigational Site Number 392019
Nagasaki
Investigational Site Number 392010
Osaka
Investigational Site Number 392021
Sapporo
Investigational Site Number 392025
Sapporo
Investigational Site Number 392002
Sendai
Investigational Site Number 392004
Shirakawa-Shi
Investigational Site Number 392016
Shunan-Shi
Investigational Site Number 392020
Suwa-Shi
Investigational Site Number 392006
Takasaki-Shi
Investigational Site Number 392001
Tomakomai-Shi
Investigational Site Number 392024
Toshima-Ku
Investigational Site Number 392015
Ube-Shi
Investigational Site Number 392011
Yakushi
About this study
Official title: Double Blind, Randomized, Placebo Controlled Dose Ranging Study of the Efficacy and Safety of Dronedarone (SR33589B) at 300, 400, or 600 mg BID for the Control of Ventricular Rate in Japanese Patients With Permanent Atrial Fibrillation
Primary Objective:
- To assess the efficacy of dronedarone versus placebo for the control of ventricular rate in patients with permanent Atrial Fibrillation (AF).
Secondary Objective:
- To assess the safety and tolerability of dronedarone after repeated oral doses of 300 mg, 400 mg, or 600 mg twice daily in the selected population.
- To document SR33589 and SR35021 trough plasma levels at steady state.
Read the detailed description
The study period per patient is approximatively 1 month broken down as follows:
- Screening period up to 7 days,
- Treatment period of 14 days,
- Follow-up period of 10 days.
- Conditions
- Atrial Fibrillation
- Being tested
- DRONEDARONE (SR33589), placebo
- 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
Pharmaceutical form: tablets
Route of administration: oral
placeboDrug
Pharmaceutical form: tablets
Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| dronedarone 300 mg | Experimental | Dronedarone, 100mg + 200mg tablets twice daily, administered with food. Receives: Drug: DRONEDARONE (SR33589) |
| dronedarone 400 mg | Experimental | Dronedarone, 400mg tablets twice daily, administered with food. Receives: Drug: DRONEDARONE (SR33589) |
| dronedarone 600 mg | Experimental | Dronedarone, 400mg + 200mg tablets twice daily, administered with food. Receives: Drug: DRONEDARONE (SR33589) |
| placebo | Placebo comparator | Matching placebo tablets twice daily, administered with food. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in mean ventricular rate measured by 24-hour Holter Electrocardiogram (ECG)
Measured: Day 14
Secondary outcomes (3)
Number of patients with adverse events
Measured: up to 10 days after last drug intake
Plasma trough concentrations for SR33589
Measured: Day 14
Plasma trough concentrations for SR35021
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionApr 2011
- Study completionApr 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 181 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
- NCT01213368
- Sponsor's protocol ID
- DRI10939
- Other IDs
- U1111-1116-9409
- Status last verified
- Oct 2013
- First submitted
- 30 Sep 2010
- Last updated
- 16 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind, Randomized, Placebo Controlled Dose Ranging Study of the Efficacy and Safety of Dronedarone (SR33589B) at 300, 400, or 600 mg BID for the Control of Ventricular Rate in Japanese Patients With Permanent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT01213368
- Acronym / sponsor ID
- DRI10939
- Conditions
- Atrial Fibrillation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 4 Oct 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.
Primary Objective:
- To assess the efficacy of dronedarone versus placebo for the control of ventricular rate in patients with permanent Atrial Fibrillation (AF).
Secondary Objective:
- To assess the safety and tolerability of dronedarone after repeated oral doses of 300 mg, 400 mg, or 600 mg twice daily in the selected population.
- To document SR33589 and SR35021 trough plasma levels at steady state.
Detailed description
The study period per patient is approximatively 1 month broken down as follows:
- Screening period up to 7 days,
- Treatment period of 14 days,
- Follow-up period of 10 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| dronedarone 300 mg | Experimental | Drug: DRONEDARONE (SR33589)Dronedarone, 100mg + 200mg tablets twice daily, administered with food. |
| dronedarone 400 mg | Experimental | Drug: DRONEDARONE (SR33589)Dronedarone, 400mg tablets twice daily, administered with food. |
| dronedarone 600 mg | Experimental | Drug: DRONEDARONE (SR33589)Dronedarone, 400mg + 200mg tablets twice daily, administered with food. |
| placebo | Placebo comparator | Drug: placeboMatching placebo tablets twice daily, administered with food. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients of aged 20 years or more.
- Permanent Atrial Fibrillation [AF] (defined as duration of AF > 6 months) for which cardioversion is not considered and with resting ventricular heart rate ≥ 80 bpm at screening.
Key exclusion criteria (10 listed)
- Unstable angina pectoris.
- History of torsades de pointes.
- Prolonged QT corrected interval (≥ 500 ms).
- Third degree atrioventricular block (AVB) on the screening ECG while in AF or, documentation on previous ECGs while in sinus rhythm of PR-interval > 0.28 sec or high degree AVB (2nd degree or higher) or, significant sinus node disease (documented pause ≥ 3 sec) - without a permanent pacemaker implanted.
- Congestive Heart Failure (CHF) of New York Heart Association classification (NYHA) class IV or recent (within 1 month prior to randomization) unstable NYHA class III.
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)Pharmaceutical form: tablets Route of administration: oral | Drug | dronedarone 300 mg, dronedarone 400 mg, dronedarone 600 mg |
| placeboPharmaceutical form: tablets Route of administration: oral | Drug | placebo |
Primary outcome
Change from baseline in mean ventricular rate measured by 24-hour Holter Electrocardiogram (ECG)
Time frame: Day 14
3 secondary outcomes
Number of patients with adverse events
Time frame: up to 10 days after last drug intake
Plasma trough concentrations for SR33589
Time frame: Day 14
Plasma trough concentrations for SR35021
Time frame: Day 14
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 16 Oct 2013.
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
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
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DRONEDARONE (SR33589) in people with Atrial Fibrillation, run by Sanofi at 25 sites in Japan.
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 10 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 16 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Japan. 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. Some participants in this study may receive a placebo. 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?
Change from baseline in mean ventricular rate measured by 24-hour Holter Electrocardiogram (ECG) (time frame: Day 14). 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 16 Oct 2013.