Brief Summary

The purpose of this study is to assess the efficacy of dronedarone for the control of ventricular rate at rest and during exercise in patients with atrial fibrillation (AF) and to assess the tolerability of dronedarone in the target population.

Trial Health

On Track

Trial Health Score

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

Enrollment

174

participants targeted

Target at P25-P50 for phase_3 atrial-fibrillation

Timeline

Completed

Started Aug 2002

Shorter than P25 for phase_3 atrial-fibrillation

Geographic Reach

9 countries

9 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

1.8 years study duration

Study Start

First participant enrolled

August 1, 2002

Completed

1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2004

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed

4 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2008

Completed

1 day until next milestone

First Posted

Study publicly available on registry

June 13, 2008

Completed

Last Updated

July 30, 2009

Status Verified

July 1, 2009

Enrollment Period

1.8 years

First QC Date

June 12, 2008

Last Update Submit

July 28, 2009

Conditions

Atrial Fibrillation

Keywords

Heart disease

Outcome Measures

Primary Outcomes (1)

Change from baseline in mean ventricular rate at rest and during exercise
Day 14

Study Arms (2)

1

EXPERIMENTAL

Drug: Dronedarone (SR33589)

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Dronedarone (SR33589)DRUG

PlaceboDRUG

Eligibility Criteria

Age21 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients with symptomatic permanent AF (\>6 months) for which cardioversion is not considered and resting ventricular rate \> or equal 80 bpm at screening measured on a 6-seconds rhythm strip,

You may not qualify if:

Unstable angina pectoris, recent myocardial infarction or history of torsades de pointes
Third degree atrioventricular block at the screening ECG or significant sinus node disease without a permanent pacemaker implanted
Clinically overt congestive heart failure at randomization
Patients treated with amiodarone, other antiarrhythmic drugs or previous participation in this trial or in other dronedarone trials or taking an investigational drug
Clinically relevant haematologic, hepatic, gastro-intestinal, renal, pulmonary, endocrinologic or psychiatric disease
Pregnant and/or breastfeeding women or women of child-bearing potential with no adequate birth control
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contact the study team to confirm eligibility.