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 AF/AFL-related symptoms. To assess the efficacy of dronedarone versus placebo on ventricular rate control in case of AF/AFL recurrence.

Trial Health

On Track

Trial Health Score

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

Enrollment

615

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

12 countries

12 active sites

Status

completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

1.7 years study duration

Study Start

First participant enrolled

November 1, 2001

Completed

1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2003

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2003

Completed

2.3 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 9, 2010

Status Verified

February 1, 2010

Enrollment Period

1.7 years

First QC Date

November 25, 2005

Last Update Submit

February 8, 2010

Conditions

Atrial Fibrillation Atrial 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

PLACEBO COMPARATOR

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 randomization 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.