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Trial record 2 of 14 for:    pallas

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

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ClinicalTrials.gov Identifier: NCT01151137
Recruitment Status : Terminated (The study was stopped because of safety concerns)
First Posted : June 25, 2010
Results First Posted : October 26, 2012
Last Update Posted : October 26, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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).


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: Dronedarone Drug: Placebo (for Dronedarone) Phase 3

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3236 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : July 2010
Primary Completion Date : September 2011
Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Dronedarone
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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)



Outcome Measures

Primary Outcome Measures :
  1. 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) ]

    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.


  2. 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) ]

    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.


  3. 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) ]

    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 :
  1. Deaths [ Time Frame: From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year) ]
    Deaths were classified according to the primary cause of death.

  2. 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) ]

    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:
  1. Overview of Cardiovascular Events [ Time Frame: From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year) ]
  2. Overview of Adverse Events [AE] [ Time Frame: from first study drug intake up to 10 days after the last study drug intake ]
    AE are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01151137


  Show 37 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01151137     History of Changes
Other Study ID Numbers: EFC11405
2010-019791-73 ( EudraCT Number )
U1111-1116-5566 ( Other Identifier: UTN )
First Posted: June 25, 2010    Key Record Dates
Results First Posted: October 26, 2012
Last Update Posted: October 26, 2012
Last Verified: October 2012

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Amiodarone
Anti-Arrhythmia Agents
Vasodilator Agents
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Sodium Channel Blockers
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 CYP3A Inhibitors