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HARMONY trial on PAF enrolling

Recruitment continues for the HARMONY trial (A Study to Evaluate the Effect of Ranolazine and Dronedarone When Given Alone and in Combination in Patients With Paroxysmal Atrial Fibrillation), a randomised, pacemaker-patient-based trial to examine the efficacy and safety of dronedarone (Multaq,® Sanofi) and ranolazine (Ranexa,® Gilead Sciences) on AF burden.

Roughly 150 patients will be enrolled at 45 sites in North America and Europe, with the study estimated to complete in September 2013.  The HARMONY study is designed to evaluate the effect of ranolazine and low dose dronedarone when given alone and in combination on atrial fibrillation burden (AFB) in patients with paroxysmal atrial fibrillation (PAF) over 12 weeks of treatment.

Gilead spokesperson Nathan Kaiser told BJC Arrhythmia Watch: “Initiation of this proof-of-concept study is an important milestone as Gilead seeks to develop a fixed-dose combination (FDC) of ranolazine and low dose dronedarone for paroxysmal/persistent (non-permanent) AF”.

“Preclinical data published in the Journal of the American College of Cardiology in 2010 suggest the combination of ranolazine and dronedarone has synergistic effects, with greater suppression of AF than either of the two therapies alone”.

“Based on preclinical data and Phase 1 studies conducted to date, Gilead believes a ranolazine-dronedarone FDC has the potential to be safer and more efficacious than dronedarone used alone at a higher dose, providing a much needed alternative therapy for people living with non-permanent AF”.

References

1 Clinicaltrials.gov (http://www.clinicaltrials.gov/ct2/show/NCT01522651?term=ranolazine+and+dronedarone&rank=1)

Published on: April 18, 2012

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ENDORSED BY

  • ArrhythmiaAlliance
  • Stars
  • Anticoagulation Europe
  • Atrial Fibrillation Association
 

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