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Permanent Atrial fibriLLAtion Outcome Study Using Dronedarone on Top of Standard Therapy (PALLAS)

This study has been terminated.
(The study was stopped because of safety concerns)
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01151137
First received: June 22, 2010
Last updated: October 23, 2012
Last verified: October 2012
  Purpose

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).


Condition Intervention Phase
Atrial Fibrillation
Drug: Dronedarone
Drug: Placebo (for Dronedarone)
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Overview of the Two Co-primary Outcomes [ Time Frame: From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year) ] [ Designated as safety issue: No ]

    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.


  • Time to First Co-primary Outcome (Cumulative Incidence Function) [ Time Frame: From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year) ] [ Designated as safety issue: No ]

    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.


  • Time to Second Co-primary Outcome (Cumulative Incidence Function) [ Time Frame: From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year) ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Deaths [ Time Frame: From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year) ] [ Designated as safety issue: No ]
    Deaths were classified according to the primary cause of death.

  • Time to Cardiovascular Death (Cumulative Incidence Function) [ Time Frame: From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year) ] [ Designated as safety issue: No ]

    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.



Other Outcome Measures:
  • Overview of Cardiovascular Events [ Time Frame: From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year) ] [ Designated as safety issue: No ]
  • Overview of Adverse Events [AE] [ Time Frame: from first study drug intake up to 10 days after the last study drug intake ] [ Designated as safety issue: Yes ]
    AE are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.


Enrollment: 3236
Study Start Date: July 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dronedarone
Dronedarone 400 mg twice a day until the CSED
Drug: Dronedarone

Film-coated tablet

Oral administration under fed conditions (during breakfast and dinner)

Other Names:
  • MULTAQ
  • SR33589
Placebo Comparator: placebo
Placebo (for Dronedarone) twice a day until the CSED
Drug: Placebo (for Dronedarone)

film-coated tablet strictly identical in appearance

Oral administration under fed conditions (during breakfast and dinner)


Detailed 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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01151137

  Hide Study Locations
Locations
United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Argentina
Sanofi-Aventis Administrative Office
Buenos Aires, Argentina
Australia
Sanofi-Aventis Administrative Office
Macquarie Park, Australia
Austria
Sanofi-Aventis Administrative Office
Vienna, Austria
Belgium
Sanofi-Aventis Administrative Office
Diegem, Belgium
Brazil
Sanofi-Aventis Administrative Office
Sao Paulo, Brazil
Bulgaria
Sanofi-Aventis Administrative Office
Sofia, Bulgaria
Canada
Sanofi-Aventis Administrative Office
Laval, Canada
Chile
Sanofi-Aventis Administrative Office
Providencia Santiago, Chile
Czech Republic
Sanofi-Aventis Administrative Office
Praha, Czech Republic
Denmark
Sanofi-Aventis Administrative Office
Horsholm, Denmark
Finland
Sanofi-Aventis Administrative Office
Helsinki, Finland
France
Sanofi-Aventis Administrative Office
Paris, France
Germany
Sanofi-Aventis Administrative Office
Frankfurt, Germany
Greece
Sanofi-Aventis Administrative Office
Kallithea, Greece
Hong Kong
Sanofi-Aventis Administrative Office
Hong Kong, Hong Kong
Hungary
Sanofi-Aventis Administrative Office
Budapest, Hungary
Israel
Sanofi-Aventis Administrative Office
Natanya, Israel
Italy
Sanofi-Aventis Administrative Office
Milan, Italy
Korea, Republic of
Sanofi-Aventis Administrative Office
Seoul, Korea, Republic of
Malaysia
Sanofi-Aventis Administrative Office
Kuala Lumpur, Malaysia
Mexico
Sanofi-Aventis Administrative Office
Col. Coyoacan, Mexico
Netherlands
Sanofi-Aventis Administrative Office
Gouda, Netherlands
New Zealand
Sanofi-Aventis Administrative Office
Auckland, New Zealand
Norway
Sanofi-Aventis Administrative Office
Lysaker, Norway
Poland
Sanofi-Aventis Administrative Office
Warsaw, Poland
Romania
Sanofi-Aventis Administrative Office
Bucuresti, Romania
Russian Federation
Sanofi-Aventis Administrative Office
Moscow, Russian Federation
Singapore
Sanofi-Aventis Administrative Office
Singapore, Singapore
Slovakia
Sanofi-Aventis Administrative Office
Bratislava, Slovakia
South Africa
Sanofi-Aventis Administrative Office
Gauteng, South Africa
Spain
Sanofi-Aventis Administrative Office
Barcelona, Spain
Sweden
Sanofi-Aventis Administrative Office
Bromma, Sweden
Switzerland
Sanofi-Aventis Administrative Office
Geneva, Switzerland
Taiwan
Sanofi-Aventis Administrative Office
Taipei, Taiwan
Ukraine
Sanofi-Aventis Administrative Office
Kiev, Ukraine
United Kingdom
Sanofi-Aventis Administrative Office
Guildford Surrey, United Kingdom
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Publications:
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01151137     History of Changes
Other Study ID Numbers: EFC11405, 2010-019791-73, U1111-1116-5566
Study First Received: June 22, 2010
Results First Received: September 14, 2012
Last Updated: October 23, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes
Amiodarone
Anti-Arrhythmia Agents
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on October 23, 2014