Trial record 1 of 7 for:    pallas
Previous Study | Return to List | Next Study

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

June 22, 2010
October 23, 2012
July 2010
September 2011   (final data collection date for primary outcome measure)
  • 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.

  • Time from randomization to first occurrence among stroke, systemic arterial embolism, myocardial infarction or cardiovascular death [ Time Frame: Follow-up between 3 months (last patient) and 3 years (first patient) ] [ Designated as safety issue: No ]
    The follow-up is until the common study end date that is a fixed date that will be set by the Steering Committee during the study.
  • Time from randomization to first occurrence of unscheduled cardiovascular hospitalization or death from any cause [ Time Frame: Follow-up between 3 months (last patient) and 3 years (first patient) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01151137 on ClinicalTrials.gov Archive Site
  • 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.

Time from randomization to cardiovascular death [ Time Frame: Follow-up between 3 months (last patient) and 3 years (first patient) ] [ Designated as safety issue: No ]
  • 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.
Not Provided
 
Permanent Atrial fibriLLAtion Outcome Study Using Dronedarone on Top of Standard Therapy
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

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).

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Atrial Fibrillation
  • Drug: Dronedarone

    Film-coated tablet

    Oral administration under fed conditions (during breakfast and dinner)

    Other Names:
    • MULTAQ
    • SR33589
  • Drug: Placebo (for Dronedarone)

    film-coated tablet strictly identical in appearance

    Oral administration under fed conditions (during breakfast and dinner)

  • Experimental: Dronedarone
    Dronedarone 400 mg twice a day until the CSED
    Intervention: Drug: Dronedarone
  • Placebo Comparator: placebo
    Placebo (for Dronedarone) twice a day until the CSED
    Intervention: Drug: Placebo (for Dronedarone)
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-Hermosillo A, Granger CB, Heidbüchel H, Kautzner J, Kim JS, Lanas F, Lewis BS, Merino JL, Morillo C, Murin J, Narasimhan C, Paolasso E, Parkhomenko A, Peters NS, Sim KH, Stiles MK, Tanomsup S, Toivonen L, Tomcsányi J, Torp-Pedersen C, Tse HF, Vardas P, Vinereanu D, Xavier D, Zhu J, Zhu JR, Baret-Cormel L, Weinling E, Staiger C, Yusuf S, Chrolavicius S, Afzal R, Hohnloser SH; PALLAS Investigators. Dronedarone in high-risk permanent atrial fibrillation. N Engl J Med. 2011 Dec 15;365(24):2268-76. doi: 10.1056/NEJMoa1109867. Epub 2011 Nov 14. Erratum in: N Engl J Med. 2012 Feb 16;366(7):672.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
3236
September 2011
September 2011   (final data collection date for primary outcome measure)

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.

Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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
 
NCT01151137
EFC11405, 2010-019791-73, U1111-1116-5566
Yes
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP