AzTrials
AzTrials

Atrial FibrillationPhase 4ARTEMIS AF LTNCT01199081

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

A Phase 4 study testing Dronedarone in people with Atrial Fibrillation, run by Sanofi at 40 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
Dronedarone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
154 participants
Where
40 sitesin 7 countries
Study dates
Oct 2010to Apr 2012
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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
Show all 25Show fewer
  • 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.

Trial locations and contacts

40 sites in 7 countries.

40 sites in 7 countries

Czechia8 sites

  • Investigational Site Number 203005

    Brno

  • Investigational Site Number 203003

    Kladno, 27280

  • Investigational Site Number 203002

    Olomouc

  • Investigational Site Number 203007

    Prachatice, 38301

  • Investigational Site Number 203001

    Prague, 12808

  • Investigational Site Number 203004

    Prague, 19000

  • Investigational Site Number 203008

    Příbram, 26101

  • Investigational Site Number 203006

    Sternberk, 78501

Other trials in Czechia

Colombia6 sites

  • Investigational Site Number 170001

    Bogotá

  • Investigational Site Number 170002

    Bucaramanga

  • Investigational Site Number 170003

    Cartagena

  • Investigational Site Number 170006

    Cartagena

  • Investigational Site Number 170007

    Floridablanca

  • Investigational Site Number 170005

    Medellín

Other trials in Colombia

France6 sites

  • Investigational Site Number 250-004

    Amiens, 80054

  • Investigational Site Number 250-005

    Boulogne-Billancourt, 92104

  • Investigational Site Number 250-003

    Chambray-lès-Tours, 37171

  • Investigational Site Number 250-002

    Grenoble, 38043

  • Investigational Site Number 250-001

    Montpellier, 34295

  • Investigational Site Number 250-006

    Toulouse, 31059

Other trials in France

Mexico6 sites

  • Investigational Site Number 484003

    Aguascalientes, 20020

  • Investigational Site Number 484002

    México, 11340

  • Investigational Site Number 484001

    San Luis Potosí City, 72244

  • Investigational Site Number 484005

    San Luis Potosí City, 78200

  • Investigational Site Number 484004

    Torreón, 27000

  • Investigational Site Number 484006

    Zapopan, 45200

Other trials in Mexico

Spain6 sites

  • Investigational Site Number 724004

    Barakaldo, 48903

  • Investigational Site Number 724001

    Barcelona, 08036

  • Investigational Site Number 724005

    L'Hospitalet de Llobregat, 08907

  • Investigational Site Number 724002

    Madrid, 28046

  • Investigational Site Number 724003

    Málaga, 29010

  • Investigational Site Number 724006

    Valdemoro, 28342

Other trials in Spain

Germany5 sites

  • Investigational Site Number 276-001

    Bonn, 53105

  • Investigational Site Number 276-002

    Chemnitz, 09111

  • Investigational Site Number 276-005

    Hagen, 58095

  • Investigational Site Number 276-003

    Nuremberg, 90402

  • Investigational Site Number 276-004

    Wermsdorf, 04779

Other trials in Germany

Denmark3 sites

  • Investigational Site Number 208-001

    Aarhus, 8000

  • Investigational Site Number 208-002

    Copenhagen, 2400

  • Investigational Site Number 208-003

    København S, 2300

Other trials in Denmark

About this study

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.

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
Read the detailed description

The maximum study duration per patient is 10 weeks

Being tested
Dronedarone
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DronedaroneDrug

    Also called Multaq®, SR33589

    Pharmaceutical form: tablet

    Route of administration: oral (together with meal)

    Dose regimen: 400 mg twice daily

Study groups in NCT01199081
Study groupRoleWhat they receive
Group AExperimentalDronedarone 400 mg twice daily for 8 weeks starting from randomization. The last 2 months regimen of Amiodarone 200 mg/day is continued until randomization.
Receives: Drug: Dronedarone
Group BExperimentalDronedarone 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.
Receives: Drug: Dronedarone
Group CExperimentalDronedarone 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.
Receives: Drug: Dronedarone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Plasma levels of dronedarone and its metabolite

    Measured: 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 outcomes (5)

  1. Plasma levels of amiodarone and its metabolite

    Measured: 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

    Measured: From randomization up to 60 days after

  3. Number of patients with Adverse Events of Special Interest (AESIs)

    Specific AESIs are: congestive Heart Failure (CHF), Interstitial lung disease , severe skin disorders, peripheral neuropathy including optic neuropathy and increase in alanine aminotransferase (ALT)

    Measured: Up to 8 weeks after randomization

  4. Number of patients with symptomatic bradycardia (Heart Rate (HR) < 50 beats per minute at rest)

    Measured: Up to 8 weeks after randomization

  5. Number of patients with symptomatic tachycardia (HR > 120 beats per minute at rest)

    Measured: Up to 8 weeks after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2010 (estimated)
  2. Study startOct 2010
  3. Primary completionApr 2012
  4. Study completionApr 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
154 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01199081
Sponsor's protocol ID
DRONE_C_04629
Other IDs
2010-019247-19
Acronym
ARTEMIS AF LT
Status last verified
Jun 2013
First submitted
9 Sep 2010
Last updated
7 Jun 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Naccarelli GV, Bhatt DL, Camm AJ, Le Heuzey JY, Lombardi F, Tamargo J, Martinez JM, Naditch-Brule L; ARTEMIS AF Investigators. Evaluation of the Switch From Amiodarone to Dronedarone in Patients With Atrial Fibrillation: Results of the ARTEMIS AF Studies. J Cardiovasc Pharmacol Ther. 2020 Sep;25(5):425-437. doi: 10.1177/1074248420926874. Epub 2020 Jun 5.

    PubMed 32500725

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dronedarone in people with Atrial Fibrillation, run by Sanofi at 40 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in Czechia, Colombia, France, Mexico, Spain and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01199081, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in