Press Release: Phase III Tracleer (bosentan) study in chronic heart failure does not meet primary efficacy objective.

Actelion Ltd and Genentech Inc have announced that the Phase III ENABLE program evaluating endothelin receptor antagonist Tracleer (bosentan) in 1613 patients with severe chronic heart failure did not reach statistical significance in the two pre-defined primary endpoints: risk reduction in time to death or hospitalisation due to CHR, and improvement in clinical status at nine months of treatment. Although efficacy in CHF for Tracleer was not observed, the trial did generate long-term data about safety in patients receiving Tracleer for up to 30 months, confirming the same safety profile as observed in earlier clinical trials. The companies will …