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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00259376




Registration number
NCT00259376
Ethics application status
Date submitted
25/11/2005
Date registered
29/11/2005
Date last updated
15/02/2010

Titles & IDs
Public title
American-Australian-African Trial With Dronedarone in Patients With Atrial Fibrillation or Atrial Flutter for the Maintenance of Sinus Rhythm
Scientific title
American-Australian-African Trial With Dronedarone in Atrial Fibrillation or Flutter Patients for the Maintenance of Sinus Rhythm (ADONIS)
Secondary ID [1] 0 0
SR33589B
Secondary ID [2] 0 0
EFC4788
Universal Trial Number (UTN)
Trial acronym
ADONIS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 0 0
Atrial Flutter 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Dronedarone (SR33589)
Treatment: Drugs - placebo

Experimental: Dronedarone 400mg bid - dronedarone 400mg tablets

Experimental: Placebo - matching placebo tablets


Treatment: Drugs: Dronedarone (SR33589)
oral administration

Treatment: Drugs: placebo
oral administration
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The primary endpoint of the study is the time from randomisation to first documented AF/AFL recurrence
Timepoint [1] 0 0
Secondary outcome [1] 0 0
- AF/AFL related symptoms collected at the time of ECG/TTEM recording,
Timepoint [1] 0 0
Secondary outcome [2] 0 0
- mean ventricular rate during AF/AFL at first recorded AF/AFL recurrence (12-lead ECG or TTEM)
Timepoint [2] 0 0
Secondary outcome [3] 0 0
- time from presumed study drug near steady state defined as D5 midnight to first documented AF/AFL recurrence as indicated by ECG/TTEM recording.
Timepoint [3] 0 0

Eligibility
Key inclusion criteria
- 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.
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2001
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2003
Sample size
Target
Accrual to date
Final
629
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
sanofi-aventis Australia administrative office - Macquarie Park
Recruitment postcode(s) [1] 0 0
- Macquarie Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New Jersey
Country [2] 0 0
Argentina
State/province [2] 0 0
Buenos Aires
Country [3] 0 0
Canada
State/province [3] 0 0
Laval
Country [4] 0 0
South Africa
State/province [4] 0 0
Midrand

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT00259376
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ICD CSD
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00259376