News|Articles|March 1, 2003

ANDROMEDA study of dronedarone ends due to potential excess risk of death

Sanofi-Synthélabo has decided to discontinue ANDROMEDA under advisementfrom its steering committee and the independent Data Safety and MonitoringBoard (DSMB) for the study, the company announced recently. ANDROMEDA wasa double-blind, placebo-controlled study in the process of evaluating theuse of dronedarone in high-risk patients with congestive heart failure andventricular dysfunction. A total of 627 of the intended 1,000 patients hadalready been enrolled in the study.

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