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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/NCT00489736




Registration number
NCT00489736
Ethics application status
Date submitted
20/06/2007
Date registered
21/06/2007
Date last updated
18/02/2010

Titles & IDs
Public title
Efficacy & Safety of Dronedarone Versus Amiodarone for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation
Scientific title
Randomized Double Blind Trial to Evaluate the Efficacy and Safety of Dronedarone (400mg BID) Versus Amiodarone (600mg Daily for 28 Days, Then 200mg Daily Thereafter) for at Least 6 Months for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation (AF)
Secondary ID [1] 0 0
EFC4968
Universal Trial Number (UTN)
Trial acronym
DIONYSOS
Linked study record

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

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

Experimental: Dronedarone 400mg bid - dronedarone 400mg tablets administered twice a day (bid) and matching over-encapsulated tablets of placebo of amiodarone 200mg

Active Comparator: Amiodarone 600mg/200mg od - over-encapsulated tablets of amiodarone 200mg (600mg daily for 28 days then 200mg daily) administered once daily (od) and matching placebo of dronedarone 400mg tablets


Treatment: Drugs: dronedarone (SR33589)
oral administration

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

Outcomes
Primary outcome [1] 0 0
Treatment Failure
Timepoint [1] 0 0
minimum study duration is 6 months (+10 days); maximum is 15 months
Secondary outcome [1] 0 0
Occurrence of the Main Safety Endpoint (MSE) Defined as Thyroid, Hepatic, Pulmonary, Neurological, Skin, Eye, or Gastrointestinal Specific Treatment Emergent Events or Premature Study Drug Discontinuation Following Any Adverse Event
Timepoint [1] 0 0
minimum study duration is 6 months (+10 days); maximum is 15 months

Eligibility
Key inclusion criteria
- Patients with documented atrial fibrillation for more than 72 hours for whom
cardioversion and antiarrhythmic treatment is indicated in the opinion of the
investigator and under oral anticoagulation
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Contraindication to oral anticoagulation

- Patient having received amiodarone in the past whatever the date (more than a total of
twenty 200 mg tablets or more than 5 days intravenous)

- Patients known to have chronic AF, patients with atrial flutter or paroxysmal atrial
fibrillation

- Severe congestive heart failure with New-York Heart Association (NYHA) class III or
IV, severe bradycardia, high degree atrio-ventricular block, ongoing potentially
dangerous symptoms when in AF such as angina pectoris, transient ischemic attacks,
stroke, syncope, as judged by the investigator, first degree family history of sudden
cardiac death below age 50 years in the absence of coronary heart disease, significant
sinus node disease without a permanent pacemaker implanted

- History of torsades de pointes or long QT syndrome or QT- or QTc-interval =500 msecs
before randomization

- Treatment with other class I or III antiarrhythmic drugs which cannot be discontinued

- Dysthyroidism or other contraindication to amiodarone

The above information are not intended to contain all the considerations relevant to a
patient's potential participation in a clinical trial.

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 administering 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
1/06/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2008
Sample size
Target
Accrual to date
Final
504
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sanofi-Aventis Administrative Office - Cove
Recruitment postcode(s) [1] 0 0
- Cove
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
Austria
State/province [3] 0 0
Vienna
Country [4] 0 0
Belgium
State/province [4] 0 0
Diegem
Country [5] 0 0
Canada
State/province [5] 0 0
Laval
Country [6] 0 0
Chile
State/province [6] 0 0
Santiago
Country [7] 0 0
China
State/province [7] 0 0
Shangaï
Country [8] 0 0
Czech Republic
State/province [8] 0 0
Praha
Country [9] 0 0
Estonia
State/province [9] 0 0
Tallinn
Country [10] 0 0
Finland
State/province [10] 0 0
Helsinki
Country [11] 0 0
France
State/province [11] 0 0
Paris
Country [12] 0 0
Germany
State/province [12] 0 0
Berlin
Country [13] 0 0
Italy
State/province [13] 0 0
Milan
Country [14] 0 0
Korea, Republic of
State/province [14] 0 0
Seoul
Country [15] 0 0
Mexico
State/province [15] 0 0
Mexico
Country [16] 0 0
Morocco
State/province [16] 0 0
Casablanca
Country [17] 0 0
Netherlands
State/province [17] 0 0
Gouda
Country [18] 0 0
Poland
State/province [18] 0 0
Warszawa
Country [19] 0 0
Russian Federation
State/province [19] 0 0
Moscow
Country [20] 0 0
Sweden
State/province [20] 0 0
Bromma
Country [21] 0 0
Tunisia
State/province [21] 0 0
Megrine
Country [22] 0 0
Turkey
State/province [22] 0 0
Istanbul

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

Ethics approval
Ethics application status

Summary
Brief summary
The objective of this study is to compare the efficacy and safety of dronedarone to that of
amiodarone for the treatment of patients with atrial fibrillation.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00489736
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
International Clinical Development
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/NCT00489736