NCT00259376

Brief Summary

To assess the efficacy of dronedarone versus placebo for the maintenance of normal sinus rhythm after electrical, pharmacological or spontaneous conversion of atrial fibrillation/atrial flutter (AF/AFL). To assess the efficacy of dronedarone versus placebo on ventricular rate control in case of AF/AFL recurrence. To assess the efficacy of dronedarone versus placebo on AF/AFL-related symptoms.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
629

participants targeted

Target at P50-P75 for phase_3 atrial-fibrillation

Timeline
Completed

Started Nov 2001

Shorter than P25 for phase_3 atrial-fibrillation

Geographic Reach
5 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2001

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2003

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 25, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 29, 2005

Completed
Last Updated

February 15, 2010

Status Verified

February 1, 2010

Enrollment Period

1.8 years

First QC Date

November 25, 2005

Last Update Submit

February 12, 2010

Conditions

Atrial FibrillationAtrial Flutter

Keywords

Atrial FibrillationAtrial FlutterArrhythmiaAnti-Arrhythmia agents

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint of the study is the time from randomisation to first documented AF/AFL recurrence

Secondary Outcomes (3)

  • - AF/AFL related symptoms collected at the time of ECG/TTEM recording,

  • - mean ventricular rate during AF/AFL at first recorded AF/AFL recurrence (12-lead ECG or TTEM)

  • - time from presumed study drug near steady state defined as D5 midnight to first documented AF/AFL recurrence as indicated by ECG/TTEM recording.

Study Arms (2)

Dronedarone 400mg bid

EXPERIMENTAL

dronedarone 400mg tablets

Drug: Dronedarone (SR33589)

Placebo

EXPERIMENTAL

matching placebo tablets

Drug: placebo

Interventions

Dronedarone (SR33589)DRUG

oral administration

Also known as: Multaq®
Dronedarone 400mg bid
placeboDRUG

oral administration

Placebo

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients of either sex aged 21 years or more, in sinus rhythm for at least 1 hour at the time of randomisation and with at least one ECG-documented AF/AFL episode in the last 3 months.

You may not qualify if:

  • MAIN CRITERIA (non-exhaustive list, see protocol for details):
  • Women of childbearing potential without adequate birth control, Pregnant women, Breastfeeding women, Congestive heart failure NYHA class III or IV, Conditions which increase the risk of severe antiarrhythmic drug side effects, Severe associated conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, 08807, United States

Location

Sanofi-Aventis Administrative Office

Buenos Aires, Argentina

Location

sanofi-aventis Australia administrative office

Macquarie Park, Australia

Location

Sanofi-Aventis Administrative Office

Laval, Canada

Location

Sanofi-Aventis Administrative Office

Midrand, South Africa

Location

Related Publications (2)

  • Singh BN, Connolly SJ, Crijns HJ, Roy D, Kowey PR, Capucci A, Radzik D, Aliot EM, Hohnloser SH; EURIDIS and ADONIS Investigators. Dronedarone for maintenance of sinus rhythm in atrial fibrillation or flutter. N Engl J Med. 2007 Sep 6;357(10):987-99. doi: 10.1056/NEJMoa054686.

    PMID: 17804843RESULT

  • Handelsman Y, Bunch TJ, Rodbard HW, Steinberg BA, Thind M, Bigot G, Konigsberg L, Wieloch M, Kowey PR. Impact of dronedarone on patients with atrial fibrillation and diabetes: A sub-analysis of the ATHENA and EURIDIS/ADONIS studies. J Diabetes Complications. 2022 Jul;36(7):108227. doi: 10.1016/j.jdiacomp.2022.108227. Epub 2022 Jun 8.

    PMID: 35717354DERIVED

MeSH Terms

Conditions

Atrial FibrillationAtrial FlutterArrhythmias, Cardiac

Interventions

Dronedarone

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AmiodaroneBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • ICD CSD

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 25, 2005

First Posted

November 29, 2005

Study Start

November 1, 2001

Primary Completion

September 1, 2003

Study Completion

September 1, 2003

Last Updated

February 15, 2010

Record last verified: 2010-02

Locations

AR(1)AU(1)ZA(1)CA(1)US(1)