The primary objective of the PALLAS trial is to demonstrate a reduction in either or both of two composite outcomes which are 1. major cardiovascular events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death) or 2. cardiovascular hospitalization or death from any cause among patients with permanent atrial fibrillation and additional risk factors. The secondary objectives are to evaluate the efficacy of Multaq(R) in preventing cardiovascular death and whether the drug is well-tolerated in this patient population.
"The initiation of the PALLAS trial signals our strong belief in Multaq(R) and our commitment to improve AF patient well-being and overall cardiovascular health," said Marc Cluzel, MD, Executive Vice President, Research and Development, sanofi-aventis. "We are looking forward to first patient enrolment of PALLAS in Q3 2010."
SOURCE Sanofi-aventis