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Trial record 33 of 179 for:    DCLRE1C

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

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ClinicalTrials.gov Identifier: NCT01199081
Recruitment Status : Completed
First Posted : September 10, 2010
Last Update Posted : June 7, 2013
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: Dronedarone Phase 4

Detailed Description:
The maximum study duration per patient is 10 weeks

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, International, Multi-center, Open-label Study to Document Pharmacokinetics and Optimal Timing of Initiation of Dronedarone Treatment Following Long-term Amiodarone in Patients With Paroxysmal or Persistent Atrial Fibrillation Whatever the Reason for the Change of Treatment.
Study Start Date : October 2010
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group A

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

Pharmaceutical form: tablet

Route of administration: oral (together with meal)

Dose regimen: 400 mg twice daily

Other Names:
  • Multaq®
  • SR33589

Experimental: Group B

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

Pharmaceutical form: tablet

Route of administration: oral (together with meal)

Dose regimen: 400 mg twice daily

Other Names:
  • Multaq®
  • SR33589

Experimental: Group C

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

Other Names:
  • Multaq®
  • SR33589




Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. 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) ]
  2. Number of patients with AF recurrence [ Time Frame: From randomization up to 60 days after ]
  3. Number of patients with Adverse Events of Special Interest (AESIs) [ Time Frame: 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)

  4. Number of patients with symptomatic bradycardia (Heart Rate (HR) < 50 beats per minute at rest) [ Time Frame: Up to 8 weeks after randomization ]
  5. Number of patients with symptomatic tachycardia (HR > 120 beats per minute at rest) [ Time Frame: Up to 8 weeks after randomization ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01199081


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Locations
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Colombia
Investigational Site Number 170001
Bogota, Colombia
Investigational Site Number 170002
Bucaramanga, Colombia
Investigational Site Number 170003
Cartagena, Colombia
Investigational Site Number 170006
Cartagena, Colombia
Investigational Site Number 170007
Floridablanca, Colombia
Investigational Site Number 170005
Medellin, Colombia
Czech Republic
Investigational Site Number 203005
Brno, Czech Republic
Investigational Site Number 203003
Kladno, Czech Republic, 27280
Investigational Site Number 203002
Olomouc, Czech Republic
Investigational Site Number 203007
Prachatice, Czech Republic, 38301
Investigational Site Number 203001
Praha 2, Czech Republic, 12808
Investigational Site Number 203004
Praha 9, Czech Republic, 19000
Investigational Site Number 203008
Pribram, Czech Republic, 26101
Investigational Site Number 203006
Sternberk, Czech Republic, 78501
Denmark
Investigational Site Number 208-001
Aarhus, Denmark, 8000
Investigational Site Number 208-002
Copenhagen, Denmark, 2400
Investigational Site Number 208-003
København S., Denmark, 2300
France
Investigational Site Number 250-004
AMIENS Cedex 1, France, 80054
Investigational Site Number 250-005
Boulogne Billancourt Cedex, France, 92104
Investigational Site Number 250-003
Chambray Les Tours Cedex, France, 37171
Investigational Site Number 250-002
GRENOBLE cedex, France, 38043
Investigational Site Number 250-001
Montpellier, France, 34295
Investigational Site Number 250-006
TOULOUSE Cedex 9, France, 31059
Germany
Investigational Site Number 276-001
Bonn, Germany, 53105
Investigational Site Number 276-002
Chemnitz, Germany, 09111
Investigational Site Number 276-005
Hagen, Germany, 58095
Investigational Site Number 276-003
Nürnberg, Germany, 90402
Investigational Site Number 276-004
Wermsdorf, Germany, 04779
Mexico
Investigational Site Number 484003
Aguascalientes, Mexico, 20020
Investigational Site Number 484002
Mexico, Mexico, 11340
Investigational Site Number 484001
San Luis Potosi, Mexico, 72244
Investigational Site Number 484005
San Luis Potosi, Mexico, 78200
Investigational Site Number 484004
Torreon, Mexico, 27000
Investigational Site Number 484006
Zapopan, Mexico, 45200
Spain
Investigational Site Number 724004
Barakaldo, Spain, 48903
Investigational Site Number 724001
Barcelona, Spain, 08036
Investigational Site Number 724005
Hospitalet de Llobregat, Spain, 08907
Investigational Site Number 724002
Madrid, Spain, 28046
Investigational Site Number 724003
Málaga, Spain, 29010
Investigational Site Number 724006
Valdemoro, Spain, 28342
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01199081     History of Changes
Other Study ID Numbers: DRONE_C_04629
2010-019247-19 ( EudraCT Number )
First Posted: September 10, 2010    Key Record Dates
Last Update Posted: June 7, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Amiodarone
Dronedarone
Anti-Arrhythmia Agents
Vasodilator Agents
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Sodium Channel Blockers
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 CYP3A Inhibitors