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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01151137
Other study ID # EFC11405
Secondary ID 2010-019791-73U1
Status Terminated
Phase Phase 3
First received June 22, 2010
Last updated October 23, 2012
Start date July 2010
Est. completion date September 2011

Study information

Verified date October 2012
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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).


Description:

The study period per participant was variable depending on the enrollment in the study.

A final follow-up visit had to occur within 1 month after the CSED.


Recruitment information / eligibility

Status Terminated
Enrollment 3236
Est. completion date September 2011
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender Both
Age group 65 Years and older
Eligibility 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.

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Dronedarone
Film-coated tablet Oral administration under fed conditions (during breakfast and dinner)
Placebo (for Dronedarone)
film-coated tablet strictly identical in appearance Oral administration under fed conditions (during breakfast and dinner)

Locations

Country Name City State
Argentina Sanofi-Aventis Administrative Office Buenos Aires
Australia Sanofi-Aventis Administrative Office Macquarie Park
Austria Sanofi-Aventis Administrative Office Vienna
Belgium Sanofi-Aventis Administrative Office Diegem
Brazil Sanofi-Aventis Administrative Office Sao Paulo
Bulgaria Sanofi-Aventis Administrative Office Sofia
Canada Sanofi-Aventis Administrative Office Laval
Chile Sanofi-Aventis Administrative Office Providencia Santiago
Czech Republic Sanofi-Aventis Administrative Office Praha
Denmark Sanofi-Aventis Administrative Office Horsholm
Finland Sanofi-Aventis Administrative Office Helsinki
France Sanofi-Aventis Administrative Office Paris
Germany Sanofi-Aventis Administrative Office Frankfurt
Greece Sanofi-Aventis Administrative Office Kallithea
Hong Kong Sanofi-Aventis Administrative Office Hong Kong
Hungary Sanofi-Aventis Administrative Office Budapest
Israel Sanofi-Aventis Administrative Office Natanya
Italy Sanofi-Aventis Administrative Office Milan
Korea, Republic of Sanofi-Aventis Administrative Office Seoul
Malaysia Sanofi-Aventis Administrative Office Kuala Lumpur
Mexico Sanofi-Aventis Administrative Office Col. Coyoacan
Netherlands Sanofi-Aventis Administrative Office Gouda
New Zealand Sanofi-Aventis Administrative Office Auckland
Norway Sanofi-Aventis Administrative Office Lysaker
Poland Sanofi-Aventis Administrative Office Warsaw
Romania Sanofi-Aventis Administrative Office Bucuresti
Russian Federation Sanofi-Aventis Administrative Office Moscow
Singapore Sanofi-Aventis Administrative Office Singapore
Slovakia Sanofi-Aventis Administrative Office Bratislava
South Africa Sanofi-Aventis Administrative Office Gauteng
Spain Sanofi-Aventis Administrative Office Barcelona
Sweden Sanofi-Aventis Administrative Office Bromma
Switzerland Sanofi-Aventis Administrative Office Geneva
Taiwan Sanofi-Aventis Administrative Office Taipei
Ukraine Sanofi-Aventis Administrative Office Kiev
United Kingdom Sanofi-Aventis Administrative Office Guildford Surrey
United States Sanofi-Aventis Administrative Office Bridgewater New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  Czech Republic,  Denmark,  Finland,  France,  Germany,  Greece,  Hong Kong,  Hungary,  Israel,  Italy,  Korea, Republic of,  Malaysia,  Mexico,  Netherlands,  New Zealand,  Norway,  Poland,  Romania,  Russian Federation,  Singapore,  Slovakia,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  Ukraine,  United Kingdom, 

References & Publications (1)

Connolly SJ, Camm AJ, Halperin JL, Joyner C, Alings M, Amerena J, Atar D, Avezum Á, Blomström P, Borggrefe M, Budaj A, Chen SA, Ching CK, Commerford P, Dans A, Davy JM, Delacrétaz E, Di Pasquale G, Diaz R, Dorian P, Flaker G, Golitsyn S, Gonzalez-Hermosil — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Overview of Cardiovascular Events From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year) No
Other Overview of Adverse Events [AE] AE are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study. from first study drug intake up to 10 days after the last study drug intake Yes
Primary Overview of the Two Co-primary Outcomes First co-primary outcome was defined as the first event among stroke, systemic arterial embolism, Myocardial Infarctions [MI], or cardiovascular death.
Second co-primary outcome was defined as the first event among unscheduled cardiovascular hospitalization or death from any cause.
Both co-primary outcomes were determined based on the central review and adjudication by a blinded Adjudication Committee of all reported deaths (from any cause), MI, systemic arterial embolisms, strokes, Transient Ischemic Attacks [TIA], Heart Failure hospitalization and unplanned hospitalisations for cardiovascular cause.
From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year) No
Primary Time to First Co-primary Outcome (Cumulative Incidence Function) Time to first co-primary outcome was defined as the time from randomization to the first event among stroke, systemic arterial embolism, MI or cardiovascular death.
Cumulative incidence function in each treatment group was calculated using non-parametric Kaplan-Meier estimate.
95% confidence interval was computed at each time-point using Greenwood's variance estimation.
From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year) No
Primary Time to Second Co-primary Outcome (Cumulative Incidence Function) Time to second co-primary outcome was defined as the time from randomization to the first event among unscheduled cardiovascular hospitalization or death from any cause.
Cumulative incidence function in each treatment group was calculated using non-parametric Kaplan-Meier estimate.
95% confidence interval was computed at each time-point using Greenwood's variance estimation.
From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year) No
Secondary Deaths Deaths were classified according to the primary cause of death. From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year) No
Secondary Time to Cardiovascular Death (Cumulative Incidence Function) Time to cardiovascular death was defined as the time from randomization to the death.
Cumulative incidence function in each treatment group was calculated using non-parametric Kaplan-Meier estimate.
95% confidence interval was computed at each time-point using Greenwood's variance estimation.
From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year) No
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