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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/NCT01151137




Registration number
NCT01151137
Ethics application status
Date submitted
22/06/2010
Date registered
25/06/2010
Date last updated
26/10/2012

Titles & IDs
Public title
Permanent Atrial fibriLLAtion Outcome Study Using Dronedarone on Top of Standard Therapy
Scientific title
A Randomized, Double Blind, Placebo Controlled, Parallel Group Trial for Assessing the Clinical Benefit of Dronedarone 400mg BID on Top of Standard Therapy in Patients With Permanent Atrial Fibrillation and Additional Risk Factors
Secondary ID [1] 0 0
2010-019791-73
Secondary ID [2] 0 0
EFC11405
Universal Trial Number (UTN)
Trial acronym
PALLAS
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
Treatment: Drugs - Placebo (for Dronedarone)

Experimental: Dronedarone - Dronedarone 400 mg twice a day until the CSED

Placebo Comparator: placebo - Placebo (for Dronedarone) twice a day until the CSED


Treatment: Drugs: Dronedarone
Film-coated tablet
Oral administration under fed conditions (during breakfast and dinner)

Treatment: Drugs: Placebo (for Dronedarone)
film-coated tablet strictly identical in appearance
Oral administration under fed conditions (during breakfast and dinner)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overview of the Two Co-primary Outcomes
Timepoint [1] 0 0
From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)
Primary outcome [2] 0 0
Time to First Co-primary Outcome (Cumulative Incidence Function)
Timepoint [2] 0 0
From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)
Primary outcome [3] 0 0
Time to Second Co-primary Outcome (Cumulative Incidence Function)
Timepoint [3] 0 0
From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)
Secondary outcome [1] 0 0
Deaths
Timepoint [1] 0 0
From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)
Secondary outcome [2] 0 0
Time to Cardiovascular Death (Cumulative Incidence Function)
Timepoint [2] 0 0
From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)

Eligibility
Key inclusion criteria
Inclusion criteria:

- Permanent AF defined by the presence of all of the following criteria:

- Availability of one 12-lead ECG not more than 14 days prior to randomization
showing that the patient is in AF or atrial flutter;

- Availability of documentation (including either rhythm strips or medical report
of the rhythm) showing that the patient was in AF or atrial flutter at least 6
months prior to randomization;

- No evidence of sinus rhythm in the period between these two documentations of AF;

- Decision of the patient and physician to allow AF to continue without further
efforts to restore sinus rhythm.

- At least one of the following risk criteria:

- Coronary artery disease;

- Prior stroke or Transient Ischemic Attack [TIA];

- Symptomatic heart failure;

- Left ventricular ejection fraction [LVEF] less or equal to 0.40;

- Peripheral arterial occlusive disease;

- Aged 75 years or older with both hypertension and diabetes mellitus.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

- Paroxysmal AF;

- Persistent AF without a decision to allow AF to continue without further efforts to
restore sinus rhythm;

- Heart failure of New-York Heart Association [NYHA] class IV or recent unstable NYHA
class III.

The above information is not intended to contain all 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 assessing the outcomes
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
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2011
Sample size
Target
Accrual to date
Final
3236
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sanofi-Aventis 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
Austria
State/province [3] 0 0
Vienna
Country [4] 0 0
Belgium
State/province [4] 0 0
Diegem
Country [5] 0 0
Brazil
State/province [5] 0 0
Sao Paulo
Country [6] 0 0
Bulgaria
State/province [6] 0 0
Sofia
Country [7] 0 0
Canada
State/province [7] 0 0
Laval
Country [8] 0 0
Chile
State/province [8] 0 0
Providencia Santiago
Country [9] 0 0
Czech Republic
State/province [9] 0 0
Praha
Country [10] 0 0
Denmark
State/province [10] 0 0
Horsholm
Country [11] 0 0
Finland
State/province [11] 0 0
Helsinki
Country [12] 0 0
France
State/province [12] 0 0
Paris
Country [13] 0 0
Germany
State/province [13] 0 0
Frankfurt
Country [14] 0 0
Greece
State/province [14] 0 0
Kallithea
Country [15] 0 0
Hong Kong
State/province [15] 0 0
Hong Kong
Country [16] 0 0
Hungary
State/province [16] 0 0
Budapest
Country [17] 0 0
Israel
State/province [17] 0 0
Natanya
Country [18] 0 0
Italy
State/province [18] 0 0
Milan
Country [19] 0 0
Korea, Republic of
State/province [19] 0 0
Seoul
Country [20] 0 0
Malaysia
State/province [20] 0 0
Kuala Lumpur
Country [21] 0 0
Mexico
State/province [21] 0 0
Col. Coyoacan
Country [22] 0 0
Netherlands
State/province [22] 0 0
Gouda
Country [23] 0 0
New Zealand
State/province [23] 0 0
Auckland
Country [24] 0 0
Norway
State/province [24] 0 0
Lysaker
Country [25] 0 0
Poland
State/province [25] 0 0
Warsaw
Country [26] 0 0
Romania
State/province [26] 0 0
Bucuresti
Country [27] 0 0
Russian Federation
State/province [27] 0 0
Moscow
Country [28] 0 0
Singapore
State/province [28] 0 0
Singapore
Country [29] 0 0
Slovakia
State/province [29] 0 0
Bratislava
Country [30] 0 0
South Africa
State/province [30] 0 0
Gauteng
Country [31] 0 0
Spain
State/province [31] 0 0
Barcelona
Country [32] 0 0
Sweden
State/province [32] 0 0
Bromma
Country [33] 0 0
Switzerland
State/province [33] 0 0
Geneva
Country [34] 0 0
Taiwan
State/province [34] 0 0
Taipei
Country [35] 0 0
Ukraine
State/province [35] 0 0
Kiev
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Guildford Surrey

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

Ethics approval
Ethics application status

Summary
Brief summary
Primary Objective:

- Demonstrate the efficacy of Dronedarone in preventing major cardiovascular events
(stroke, systemic arterial embolism, myocardial infarction or cardiovascular death) or
unplanned cardiovascular hospitalization or death from any cause in patients with
permanent Atrial Fibrillation [AF] and additional risk factors

Secondary Objective:

- Demonstrate the efficacy of Dronedarone in preventing cardiovascular death

This was an event-driven study where a common study end date [CSED] was to be determined by
Steering Committee based on the number of events (stroke, systemic arterial embolism,
myocardial infarction or cardiovascular death).
Trial website
https://clinicaltrials.gov/ct2/show/NCT01151137
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
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/NCT01151137