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.

Trial Profile

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.

Discontinued
Phase of Trial: Phase III

Latest Information Update: 09 Aug 2017

At a glance

  • Drugs Dronedarone (Primary)
  • Indications Atrial fibrillation; Cardiovascular disorders
  • Focus Biomarker; Pharmacogenomic; Registrational; Therapeutic Use
  • Acronyms PALLAS
  • Sponsors Sanofi
  • Most Recent Events

    • 20 Sep 2011 New source identified and integrated (Clinical Trials Registry- India).
    • 11 Jul 2011 Planned End Date changed from 1 Aug 2013 to 1 Aug 2011 as reported by ClinicalTrials.gov.
    • 07 Jul 2011 Status changed from recruiting to discontinued due to a significant increase in cardiovascular events in the dronedarone arm of the study, according to information in a sanofi-aventis media release.
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