Sanofi-aventis has initiated PALLAS, a double-blind, multinational, randomised phase-IIIb trial to assess the clinical benefit of Multaq in over 10,000 patients with permanent atrial fibrillation (AF).
The PALLAS trial aims to demonstrate a reduction in major cardiovascular events, cardiovascular hospitalisation or death among patients with AF and additional risk factors.
The secondary objective is to study the efficacy of the drug in preventing cardiovascular death and the drug tolerance in the patient population.
About 10,800 patients are expected to be enrolled at 700 sites in 43 countries.
First patient enrolment is expected in the third quarter of 2010.