A Phase 3 interventional study of dronedarone (SR33589) and placebo in Atrial Fibrillation and Atrial Flutter, sponsored by Sanofi. Completed at 37 sites in 37 countries. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2010-01-12.
Sponsored by Sanofi · Phase 3, Interventional, and Prevention
To assess the efficacy of dronedarone in preventing cardiovascular hospitalization or death from any cause in a population of high-risk patients with atrial fibrillation/atrial flutter (AF/AFL).
To assess that dronedarone is well tolerated in this population.
This is a prospective, multinational, double-blind, randomized, multi-center, placebo-controlled, parallel-group trial evaluating the effects of dronedarone versus placebo (ratio 1:1) over a minimum treatment duration of 12 months and a mean follow-up duration of 1.75 years (in AF/AFL patients). Patients can be included in the study while in atrial fibrillation/flutter or in sinus rhythm if conversion has occurred either spontaneously or following a procedure such as electrical cardioversion (or overdrive pacing) or administration of an antiarrhythmic drug.After randomization all patients will be followed until the common study end date; the last patient included in the study will be followed for 1 year. Visits will be at baseline, after 7 days, after 14 days, after one month, after three months and then every three months until end of the study. At each visit patients will be asked for the occurrence of hospitalizations or other events since the last visit. The study will be monitored by an independent Data Monitoring Committee (DMC) for safety, tolerability and efficacy.
3,957 studies on the registry are indexed under Atrial Fibrillation; 933 are open to participants now.
This study's enrollment of 4,628 is above the median of 145 across 2,437 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Sanofi is the lead sponsor of 1,547 studies on the registry; 88 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 122 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
1. Patients aged 75 years or older (70 years before protocol amendment 1), or patients aged at least 70 years (any age before protocol amendment 1) with one or more of the following risk factors at baseline:
Exclusion Criteria:
General criteria:
Criteria Related to a cardiac condition:
Criteria Related to Concomitant Medications:
Criteria Related to Laboratory Abnormalities:
Dronedarone 400mg tablets twice daily (bid)
Drug: dronedarone (SR33589)
matching placebo tablets
Drug: placebo
oral administration (tablets)
Also known as: Multaq®
oral administration (tablets)
First Hospitalization for Cardiovascular Reason or Death From Any Cause
The primary event is the first hospitalization for cardiovascular reason or death from any cause, whichever is earlier, as assessed by the investigator. The primary efficacy analysis is performed on the time from randomization to this primary event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.
Time frame: minimum follow-up duration: 1 year ; maximum: 2.5 years
Death From Any Cause
The considered event is death from any cause. The analysis is performed on the time from randomization to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.
Time frame: minimum follow-up duration: 1 year ; maximum: 2.5 years
First Hospitalization for Cardiovascular Reason
The considered event is the first hospitalization for cardiovascular reason, as assessed by the Investigator. The analysis is performed on the time from randomization to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.
Time frame: minimum follow-up duration: 1 year ; maximum: 2.5 years
Cardiovascular Death
The considered event is cardiovascular death, as assessed by the Investigator. The analysis is performed on the time from randomization to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.
Time frame: minimum follow-up duration: 1 year ; maximum: 2.5 years
Adjudicated Cardiovascular Death
The considered event is cardiovascular death, as assessed by the blinded adjudication of the Steering Committee. The analysis is performed on the time from randomization to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.
Time frame: minimum follow-up duration: 1 year ; maximum: 2.5 years
Enrollment of patients started on June 29, 2005 and was completed on December 30, 2006. The study was conducted at 551 centers in 37 countries. The common study end date ensuring a minimum planned follow-up of one year was December 30th, 2007.
| Milestone | Dronedarone 400mg Bid | Placebo |
|---|---|---|
| Started | 2301 | 2327 |
| Completed | 1605 | 1611 |
| Not completed | 696 | 716 |
| Withdrew: Adverse event | 293 | 191 |
| Withdrew: Protocol violation | 14 | 14 |
| Withdrew: Withdrawal by subject | 173 | 175 |
| Withdrew: Atrial fibrillation/flutter recurrence | 110 | 167 |
| Withdrew: Prohibited antiarrhythmic medication | 39 | 88 |
| Withdrew: Other prohibited medication | 5 | 3 |
| Withdrew: Family request | 6 | 8 |
| Withdrew: Not pre-specified/not coded | 56 | 70 |
The primary event is the first hospitalization for cardiovascular reason or death from any cause, whichever is earlier, as assessed by the investigator. The primary efficacy analysis is performed on the time from randomization to this primary event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.
| participants | Dronedarone 400mg Bid | Placebo |
|---|---|---|
| First Hospitalization for Cardiovascular Reason or Death From Any Cause | 734 | 917 |
The considered event is death from any cause. The analysis is performed on the time from randomization to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.
| participants | Dronedarone 400mg Bid | Placebo |
|---|---|---|
| Death From Any Cause | 116 | 139 |
The considered event is the first hospitalization for cardiovascular reason, as assessed by the Investigator. The analysis is performed on the time from randomization to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.
| participants | Dronedarone 400mg Bid | Placebo |
|---|---|---|
| First Hospitalization for Cardiovascular Reason | 675 | 859 |
The considered event is cardiovascular death, as assessed by the Investigator. The analysis is performed on the time from randomization to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.
| participants | Dronedarone 400mg Bid | Placebo |
|---|---|---|
| Cardiovascular Death | 65 | 94 |
The considered event is cardiovascular death, as assessed by the blinded adjudication of the Steering Committee. The analysis is performed on the time from randomization to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.
| participants | Dronedarone 400mg Bid | Placebo |
|---|---|---|
| Adjudicated Cardiovascular Death | 63 | 90 |
Collected over In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dronedarone 400mg Bid | — | 456/2,291 (19.9%) | 1,584/2,291 (69.1%) |
| Placebo | — | 489/2,313 (21.1%) | 1,527/2,313 (66%) |
| Event | Dronedarone 400mg Bid | Placebo |
|---|---|---|
| PneumoniaInfections and infestations | 32/2291 | 45/2313 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 15/2291 | 21/2313 |
| FallInjury, poisoning and procedural complications | 20/2291 | 20/2313 |
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 13/2291 | 19/2313 |
| Renal failure acuteRenal and urinary disorders | 14/2291 | 4/2313 |
| Prostate cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 6/2291 | 11/2313 |
| Urinary tract infectionInfections and infestations | 6/2291 | 10/2313 |
| DehydrationMetabolism and nutrition disorders | 4/2291 | 10/2313 |
| Benign prostatic hyperplasiaReproductive system and breast disorders | 8/2291 | 10/2313 |
| HaematuriaRenal and urinary disorders | 7/2291 | 7/2313 |
| Event | Dronedarone 400mg Bid | Placebo |
|---|---|---|
| Any Gastrointestinal disordersGastrointestinal disorders | 573/2291 | 478/2313 |
| Any infections and infestationsInfections and infestations | 508/2291 | 533/2313 |
| Any general disorders and administration site conditionsGeneral disorders | 397/2291 | 348/2313 |
| Any musculoskeletal and connective tissue disordersMusculoskeletal and connective tissue disorders | 364/2291 | 376/2313 |
| Any nervous system disordersNervous system disorders | 362/2291 | 365/2313 |
| Any respiratory, thoracic and mediastinal disordersRespiratory, thoracic and mediastinal disorders | 315/2291 | 318/2313 |
| Any investigation disordersInvestigations | 298/2291 | 199/2313 |
| Any cardiac disordersCardiac disorders | 251/2291 | 213/2313 |
| Any skin and subcutaneous tissue disordersSkin and subcutaneous tissue disorders | 235/2291 | 174/2313 |
| DiarrhoeaGastrointestinal disorders | 222/2291 | 142/2313 |
| Age, Customized(participants) | Dronedarone 400mg Bid | Placebo | Total |
|---|---|---|---|
| 18 to < 65 years | 431 | 442 | 873 |
| 65 to < 75 years | 923 | 907 | 1830 |
| >= 75 years | 947 | 978 | 1925 |
| Age Continuous(years) | Dronedarone 400mg Bid | Placebo | Total |
|---|---|---|---|
| Mean | 71.6 ± 8.9 | 71.7 ± 9.0 | 71.6 ± 9.0 |
| Sex: Female, Male(Participants) | Dronedarone 400mg Bid | Placebo | Total |
|---|---|---|---|
| Female | 1131 | 1038 | 2169 |
| Male | 1170 | 1289 | 2459 |
The record gives a start of Jun 2005, a primary completion of Mar 2008 and a completion of Mar 2008. It does not say whether these dates are actual or estimated.
Results were first posted in Dec 2009, 1 year 9 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Dronedarone