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Sanofi-aventis commences Phase IIIb study of Multaq in permanent AF.

M2 EUROPHARMA-(C)1999-2010 M2 COMMUNICATIONS

12 May 2010 - French sanofi-aventis (EPA: SAN) said today that it has started a randomised, double-blind Phase IIIb trial, PALLAS, to assess the potential clinical benefit of Multaq (dronedarone) in over 10,000 patients with permanent atrial fibrillation (AF) to reduce major adverse cardiovascular events.

Permanent AF afflicts 50% of patients suffering from AF and these patients are at high risk of major adverse cardiovascular events, the company added.

The trial rationale was based on post-hoc findings from the landmark ATHENA trial, in which a trend towards reduction of CV hospitalisation and death was seen in patients classified as "permanent" (i.e. with AF/AFL at each ECG recording).

The primary objective of the PALLAS trial is to demonstrate a reduction in either or both of two composite outcomes which are major cardiovascular events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death) or cardiovascular hospitalisation 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 in preventing cardiovascular death and whether the drug is well-tolerated in this patient population.

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Publication:M2 Pharma
Date:May 12, 2010
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