Status:
COMPLETED
Pharmacokinetics and Optimal Timing of Dronedarone Initiation Following Long-term Amiodarone in Patients With Paroxysmal or Persistent Atrial Fibrillation
Lead Sponsor:
Sanofi
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Primary Objective: \- Explore Dronedarone and active metabolite pharmacokinetic (PK) profiles according to different timings of Dronedarone initiation. Secondary Objective: * Explore potential PK i...
Detailed Description
The maximum study duration per patient is 10 weeks
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Screening:
- 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
- Requiring a change from amiodarone treatment whatever the reason, but without liver, lung or thyroid toxicity related to previous use of amiodarone
- At least one cardiovascular risk factor (i.e. age \> 70, hypertension, diabetes, prior cerebrovascular disease or left atrial diameter \>= 50 mm
- Effective anticoagulation treatments verified by International Normalized Ratio (INR) (target INR \> 2)
- QTc Bazett \< 500 ms on 12-lead ECG
- Randomization:
- Outpatients and Inpatients (except patients hospitalized during screening period for SAE)
- Sinus rhythm
- Effective oral anticoagulation treatment verified by INR (target INR \> 2). INR should be closely monitored after initiating dronedarone in patients taking vitamin K antagonist as per their label
- QTc Bazett \< 500 ms and PR \< 280 ms on 12-lead ECG
- Exclusion criteria:
- Screening:
- Contraindication to oral anticoagulation
- Acute condition known to cause AF
- Permanent AF
- Bradycardia \< 50 bpm at rest on the 12-lead ECG
- History of, or current heart failure or left ventricular systolic dysfunction
- Unstable hemodynamic conditions
- Severe hepatic impairment
- Wolff-Parkinson-White Syndrome
- Previous catheter ablation for atrial fibrillation or catheter ablation scheduled in the next 10 weeks
- Previous history of Amiodarone intolerance or toxicity
- History of thyroid dysfunction
- Mandatory contraindicated concomitant treatment:
- potent cytochrome P450 (CYP3A4) inhibitors
- drugs or herbal products that prolong the QT interval and known to increase the risk of Torsade de Pointes
- Previous treatment with class I or class III anti-arrhythmic drugs (including sotalol) other than amiodarone if the anti-arrhythmic drug was taken less than one week before the day of screening (if taken more than one week before screening, the patient can be included)
- Randomization
- Bradycardia \< 50 bpm on the 12-lead ECG
- History of, or current heart failure or left ventricular systolic dysfunction
- Unstable hemodynamic conditions
- Severe hepatic impairment
- Mandatory contraindicated concomitant treatment:
- potent cytochrome P450 (CYP3A4) inhibitors
- drugs or herbal products that prolong the QT interval and known to increase the risk of Torsade de Pointes
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT01199081
Start Date
October 1 2010
End Date
April 1 2012
Last Update
June 7 2013
Active Locations (40)
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1
Investigational Site Number 170001
Bogotá, Colombia
2
Investigational Site Number 170002
Bucaramanga, Colombia
3
Investigational Site Number 170003
Cartagena, Colombia
4
Investigational Site Number 170006
Cartagena, Colombia