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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

Tracking Information
First Submitted Date  ICMJE September 9, 2010
First Posted Date  ICMJE September 10, 2010
Last Update Posted Date June 7, 2013
Study Start Date  ICMJE October 2010
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2013)
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) ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 9, 2010)
Plasma levels of dronedarone and its metabolite (AUC0-12hours and Cmax) [ Time Frame: First 4 weeks of treatment with Dronedarone ]
Change History Complete list of historical versions of study NCT01199081 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2013)
  • 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) [ 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)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2010)
  • Plasma levels of amiodarone and its metabolite (AUC0-12hours and Cmax) [ Time Frame: First 4 weeks of treatment with Dronedarone ]
  • AF recurrence [ Time Frame: Up to 60 days after randomization ]
    AF recurrence is documented by at least two consecutive scheduled or unscheduled 12-lead ECGs approximately 10 minutes apart and both showing AF
  • Adverse Events of Special Interest (AESIs); Congestive Heart Failure (CHF), Interstitial lung disease , severe skin disorders, peripheral neuropathy including optic neuropathy and increase in ALT [ Time Frame: Up to 8 weeks after randomization ]
  • Symptomatic bradycardia (Heart Rate (HR) < 50 beats per minute at rest) and tachycardia (HR > 120 beats per minute at rest) [ Time Frame: Up to 8 weeks after randomization ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetics and Optimal Timing of Dronedarone Initiation Following Long-term Amiodarone in Patients With Paroxysmal or Persistent Atrial Fibrillation
Official Title  ICMJE 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Atrial Fibrillation
Intervention  ICMJE Drug: Dronedarone

Pharmaceutical form: tablet

Route of administration: oral (together with meal)

Dose regimen: 400 mg twice daily

Other Names:
  • Multaq®
  • SR33589
Study Arms  ICMJE
  • 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.

    Intervention: Drug: Dronedarone
  • 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.

    Intervention: Drug: Dronedarone
  • 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.

    Intervention: Drug: Dronedarone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 6, 2013)
154
Original Estimated Enrollment  ICMJE
 (submitted: September 9, 2010)
165
Actual Study Completion Date  ICMJE April 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Colombia,   Czech Republic,   Denmark,   France,   Germany,   Mexico,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01199081
Other Study ID Numbers  ICMJE DRONE_C_04629
2010-019247-19 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP