Pharmacokinetics and Optimal Timing of Dronedarone Initiation Following Long-term Amiodarone in Patients With Paroxysmal or Persistent Atrial Fibrillation

Phase 4

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: Dronedarone

• Registration Number: NCT01199081
• Lead Sponsor: Sanofi

Brief Summary

Primary Objective:

- Explore Dronedarone and active metabolite pharmacokinetic (PK) profiles according to different timings of Dronedarone initiation.

Secondary Objective:

* Explore potential PK interaction between Dronedarone and Amiodarone

* Evaluate the rate of Atrial Fibrillation (AF) recurrence during the study period (from randomization up to 60 days after)

* To assess the safety of the change from Amiodarone to Dronedarone and Dronedarone safety

Detailed Description

The maximum study duration per patient is 10 weeks

Study Timeline

• Study First Submitted: 2010-09-09
• Study First Submitted QC: 2010-09-09
• Study First Posted: 2010-09-10
• Study Start: 2010-10
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-06
• Last Update Posted: 2013-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Dronedarone	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.
Group B	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.
Group C	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.

Primary Outcome Measures

Name	Time	Method
Plasma levels of dronedarone and its metabolite	At randomization (baseline), 3 hours after the first dose of dronedarone, after 1, 2 and 4 weeks of treatment with dronedarone (before dronedarone dose)

Secondary Outcome Measures

Name	Time	Method
Plasma levels of amiodarone and its metabolite	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	From randomization up to 60 days after
Number of patients with symptomatic bradycardia (Heart Rate (HR) < 50 beats per minute at rest)	Up to 8 weeks after randomization
Number of patients with Adverse Events of Special Interest (AESIs)	Up to 8 weeks after randomization	Specific AESIs are: congestive Heart Failure (CHF), Interstitial lung disease , severe skin disorders, peripheral neuropathy including optic neuropathy and increase in alanine aminotransferase (ALT)
Number of patients with symptomatic tachycardia (HR > 120 beats per minute at rest)	Up to 8 weeks after randomization

Trial Locations

Locations (40)

Investigational Site Number 203001; 🇨🇿 Praha 2, Czech Republic

Investigational Site Number 250-003; 🇫🇷 Chambray Les Tours Cedex, France

Investigational Site Number 276-002; 🇩🇪 Chemnitz, Germany

Investigational Site Number 484004; 🇲🇽 Torreon, Mexico

Investigational Site Number 250-004; 🇫🇷 AMIENS Cedex 1, France

Investigational Site Number 724002; 🇪🇸 Madrid, Spain

Investigational Site Number 724006; 🇪🇸 Valdemoro, Spain

Investigational Site Number 170006; 🇨🇴 Cartagena, Colombia

Investigational Site Number 203007; 🇨🇿 Prachatice, Czech Republic

Investigational Site Number 484002; 🇲🇽 Mexico, Mexico

Investigational Site Number 250-001; 🇫🇷 Montpellier, France

Investigational Site Number 724005; 🇪🇸 Hospitalet de Llobregat, Spain

Investigational Site Number 276-003; 🇩🇪 Nürnberg, Germany

Investigational Site Number 276-001; 🇩🇪 Bonn, Germany

Investigational Site Number 724004; 🇪🇸 Barakaldo, Spain

Investigational Site Number 276-004; 🇩🇪 Wermsdorf, Germany

Investigational Site Number 203003; 🇨🇿 Kladno, Czech Republic

Investigational Site Number 203004; 🇨🇿 Praha 9, Czech Republic

Investigational Site Number 484006; 🇲🇽 Zapopan, Mexico

Investigational Site Number 250-002; 🇫🇷 GRENOBLE cedex, France

Investigational Site Number 724003; 🇪🇸 Málaga, Spain

Investigational Site Number 484005; 🇲🇽 San Luis Potosi, Mexico

Investigational Site Number 724001; 🇪🇸 Barcelona, Spain

Investigational Site Number 170005; 🇨🇴 Medellin, Colombia

Investigational Site Number 203006; 🇨🇿 Sternberk, Czech Republic

Investigational Site Number 203005; 🇨🇿 Brno, Czech Republic

Investigational Site Number 484001; 🇲🇽 San Luis Potosi, Mexico

Investigational Site Number 203008; 🇨🇿 Pribram, Czech Republic

Investigational Site Number 208-001; 🇩🇰 Aarhus, Denmark

Investigational Site Number 208-003; 🇩🇰 København S., Denmark

Investigational Site Number 170003; 🇨🇴 Cartagena, Colombia

Investigational Site Number 170001; 🇨🇴 Bogota, Colombia

Investigational Site Number 170002; 🇨🇴 Bucaramanga, Colombia

Investigational Site Number 170007; 🇨🇴 Floridablanca, Colombia

Investigational Site Number 203002; 🇨🇿 Olomouc, Czech Republic

Investigational Site Number 208-002; 🇩🇰 Copenhagen, Denmark

Investigational Site Number 250-006; 🇫🇷 TOULOUSE Cedex 9, France

Investigational Site Number 250-005; 🇫🇷 Boulogne Billancourt Cedex, France

Investigational Site Number 484003; 🇲🇽 Aguascalientes, Mexico

Investigational Site Number 276-005; 🇩🇪 Hagen, Germany