Paris, France - Sanofi-Synthelabo announced on Friday that the company discontinued the Antiarrhythmic Trial with Dronedarone in Moderate to Severe CHF Evaluating Morbidity Decrease (ANDROMEDA) study, after considering the recommendations of the study's steering committee and independent data safety and monitoring board (DSMB). ANDROMEDA is a double-blind, placebo-controlled study evaluating dronedarone in high-risk patients with congestive heart failure and ventricular dysfunction. The study was conducted in Denmark, Hungary, Norway, Poland, Sweden, and the Netherlands. A total of 627 patients, out of the 1000 planned, were already enrolled in the study.

On January 16, 2003, following an interim safety analysis, the DSMB raised the issue of a potential excess risk of death in patients on active treatment.

Dronedarone is a compound that is currently assessed as a potential antiarrhythmic drug. Two phase 3 pivotal trials of dronedarone for the maintenance of sinus rhythm in patients with atrial fibrillation are continuing. These trials are EURIDIS (in Europe) and ADONIS (in North America, South America, Australia, and South Africa). Recruitment in these trials has been completed.