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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00233441




Registration number
NCT00233441
Ethics application status
Date submitted
4/10/2005
Date registered
5/10/2005
Date last updated
8/05/2012

Titles & IDs
Public title
Placebo Controlled Double-blind Dose Ranging Study of the Efficacy and Safety of SSR149744C 50, 100, 200 or 300 mg OD With Amiodarone as Calibrator for the Maintenance of Sinus Rhythm in Patients With Recent Atrial Fibrillation/Flutter
Scientific title
Placebo Controlled Double Blind Dose Ranging Study of the Efficacy and Safety of SSR149744C 50, 100, 200, or 300 mg OD, With Amiodarone as Calibrator for the Maintenance of Sinus Rhythm in Patients With Recent Atrial Fibrillation/Flutter
Secondary ID [1] 0 0
DRI5165
Universal Trial Number (UTN)
Trial acronym
MAIA
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 - CELIVARONE (SSR149744C)

Treatment: Drugs: CELIVARONE (SSR149744C)


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

Outcomes
Primary outcome [1] 0 0
The primary endpoint is the time from randomization to first documented AF/AFL recurrence indicated by 12-lead ECG or trans-telephonic ECG monitoring tracings showing AF/AFL.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
The secondary endpoints will be the following:time from randomization to first symptomatic AF/AFL recurrence - mean ventricular rate during AF/AFL at first recorded AF/AFL recurrence.
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
- Patients aged 21 years or more of either sex with documented sinus rhythm for at least
1 hour at the time of randomization with at least one ECG-documented AF/AFL episode in
the last 3 months.
Minimum age
21 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- MAIN CRITERIA (non-exhaustive list):Women of childbearing potential without adequate
birthcontrol, Pregnant Women, Breastfeeding women, contraindications to amiodarone,
conditions which increase the risk of severe antiarrhythmic drug side effects, severe
left ventricular dysfunction, 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 2/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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
sanofi-aventis Australia & New Zealand 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
Chile
State/province [4] 0 0
Santiago
Country [5] 0 0
Denmark
State/province [5] 0 0
Horsholm
Country [6] 0 0
France
State/province [6] 0 0
Paris
Country [7] 0 0
Germany
State/province [7] 0 0
Berlin
Country [8] 0 0
Hungary
State/province [8] 0 0
Budapest
Country [9] 0 0
Italy
State/province [9] 0 0
Milano
Country [10] 0 0
Japan
State/province [10] 0 0
Tokyo
Country [11] 0 0
Netherlands
State/province [11] 0 0
Gouda
Country [12] 0 0
Poland
State/province [12] 0 0
Warszawa
Country [13] 0 0
Russian Federation
State/province [13] 0 0
Moscow
Country [14] 0 0
Spain
State/province [14] 0 0
Barcelona
Country [15] 0 0
Sweden
State/province [15] 0 0
Bromma
Country [16] 0 0
Switzerland
State/province [16] 0 0
Geneva

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

Ethics approval
Ethics application status

Summary
Brief summary
Double blind study to evaluate the efficacy and tolerability of SSR149744C and select a dose
to be further investigated in the maintenance of sinus rhythm after electrical,
pharmacological or spontaneous conversion of AF/AFL.
Trial website
https://clinicaltrials.gov/show/NCT00233441
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
Other publications