Paroxysmal or persistent atrial fibrillation MedDRA version: 14.1 Level: PT Classification code 10003658 Term: Atrial fibrillation System Organ Class: 10007541 - Cardiac disorders
Conditions
Sponsors
sanofi aventis groupe
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria at screening: I01. Male or female adults aged 18 years or more, I02. Patients with paroxysmal or persistent AF having received at least 6 months of amiodarone before screening with at least the last 2 months at a regimen of 200 mg/day (during at least 5 days per week) prior to screening, I03. Requiring a change from amiodarone treatment whatever the reason, but without liver, lung or thyroid toxicity related to previous use of amiodarone I04.Patients with at least one cardiovascular risk factor (i.e. age > 70, hypertension, diabetes, prior cerebrovascular disease or left atrial diameter = 50 mm I05. Patients receiving effective anticoagulation according to ACC/AHA/ESC guidelines, verified by INR (target INR > 2), I06. QTcB 2), INR should be closely monitored after initiating dronedarone in patients taking vitamin K antagonist as per their label. I10. QTcB =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria at screening: E01. Contraindication to oral anticoagulation, E02. Documented AF episode motivating inclusion in the study after an acute condition known to cause AF (e.g. alcohol intake, thyrotoxicosis, acute infection, pericarditis, pulmonary embolism, cardiac surgery), E03. Patients with permanent AF defined as patients with an AF duration = 6 months (or duration unknown) and attempts to restore sinus rhythm no longer considered by the physician. E04. Bradycardia 5.5 mmol/l, E14. Magnesemia 5.5 mmol/l, E30. Magnesemia < 0.8 mml/l (in patient with hypo-magnesemia, magnesium defic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to explore dronedarone and SR35021 (active metabolite) PK profiles according to different timings of dronedarone initiation.;Secondary Objective: The secondary efficacy objectives are: • To explore potential PK interaction between dronedarone and amiodarone, • To evaluate the rate of AF recurrence one month and two months after randomization, • To assess the safety of the change from amiodarone to dronedarone and dronedarone safety;Primary end point(s): Pharmacokinetics criteria: Plasma levels of dronedarone and its metabolite SR35021 (AUC0-12hours and Cmax). ;Timepoint(s) of evaluation of this end point: Plasma levels of dronedarone and its metabolite SR35021 (AUC0-12hours and Cmax). • at randomization (baseline), • 3 hours after the first dose of dronedarone, • after one week of treatment with dronedarone (before dronedarone dose), • after two weeks of treatment with dronedarone (before dronedarone dose), • after four weeks of treatment with dronedarone (before dronedarone dose). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary PK endpoint: Plasma levels of amiodarone and its metabolite desethylamiodarone (AUC0-12hours and Cmax) Efficacy criterion: AF recurrence documented by at least two consecutive scheduled or unscheduled 12-lead ECGs approximately 10 minutes apart and both showing AF Safety Criteria: Secondary safety endpoints: • Symptomatic bradycardia with HR at rest 120 beats per minute, • Laboratory test (haematology, creatinine, INR, thyroid function tests and hepatic laboratory assessment: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Bilirubin • ECG parameters, • Adverse events, adverse events of special interest (AESIs), SAEs. ;Timepoint(s) of evaluation of this end point: Secondary PK endpoint: • at randomization (baseline), • 3 hours after the first dose of dronedarone, • after one week of treatment with dronedarone (before dronedarone dose), • after two weeks of treatment with dronedarone (before dronedarone dose), • after four weeks of treatment with dronedarone (before dronedarone dose). Efficacy criterion: AF recurrence at one month and at two months Secondary safety endpoints: Bradycardia/tachycardia: from V4 to V9 Laboratory test haematology:V1 and V9. creatinine:V1, V6 and V9. INR:V2, V3, V4, V6, V7, V8 and V9. thyroid function tests:at V1 and V9. hepatic laboratory assessment: at V3, V4, V6, V8 and V9. ECG parameters:at each visit Adverse events, adverse events of special interest (AESIs), SAEs: all along the study | — |
Countries
Colombia, Czech Republic, Denmark, France, Germany, Greece, Mexico, Spain
Contacts
Public Contactwww.sanofi-aventis.cz
sanofi-aventis, s.r.o.
Outcome results
None listed