A Phase 4 interventional study of Dronedarone in Atrial Fibrillation, sponsored by Sanofi. Completed at 40 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-06-07.
Sponsored by Sanofi · Phase 4, Interventional, and Treatment
Primary Objective:
Secondary Objective:
The maximum study duration per patient is 10 weeks
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 154 is close to the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Screening:
Randomization:
Exclusion criteria:
Screening:
Mandatory contraindicated concomitant treatment:
Randomization
Mandatory contraindicated concomitant treatment:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Dronedarone 400 mg twice daily for 8 weeks starting from randomization. The last 2 months regimen of Amiodarone 200 mg/day is continued until randomization.
Drug: Dronedarone
Dronedarone 400 mg twice daily for 6 weeks starting 2 weeks after randomization. The last 2 months regimen of Amiodarone 200 mg/day is continued until randomization.
Drug: Dronedarone
Dronedarone 400 mg twice daily for 4 weeks starting 4 weeks after randomization. The last 2 months regimen of Amiodarone 200 mg/day is continued until randomization.
Drug: Dronedarone
Pharmaceutical form: tablet Route of administration: oral (together with meal) Dose regimen: 400 mg twice daily
Also known as: Multaq®, SR33589
Plasma levels of dronedarone and its metabolite
Time frame: At randomization (baseline), 3 hours after the first dose of dronedarone, after 1, 2 and 4 weeks of treatment with dronedarone (before dronedarone dose)
Plasma levels of amiodarone and its metabolite
Time frame: At randomization (baseline), 3 hours after the first dose of dronedarone, after 1, 2 and 4 weeks of treatment with dronedarone (before dronedarone dose)
Number of patients with AF recurrence
Time frame: From randomization up to 60 days after
Number of patients with Adverse Events of Special Interest (AESIs)
Specific AESIs are: congestive Heart Failure (CHF), Interstitial lung disease , severe skin disorders, peripheral neuropathy including optic neuropathy and increase in alanine aminotransferase (ALT)
Time frame: Up to 8 weeks after randomization
Number of patients with symptomatic bradycardia (Heart Rate (HR) < 50 beats per minute at rest)
Time frame: Up to 8 weeks after randomization
Number of patients with symptomatic tachycardia (HR > 120 beats per minute at rest)
Time frame: Up to 8 weeks after randomization
This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.
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Sanofi