Sweetlove, M. Pharm Med (2012) 26: 253. doi:10.1007/BF03262483
A randomized, double-blind, placebo-controlled study assessing the effect of RO4607381 on cardiovascular mortality and morbidity in clinically stable patients with a recent acute coronary syndrome.
This trial was designed to investigate the efficacy and tolerability of dalcetrapib (RO4607381) in clinically stable patients with a recent acute coronary syndrome. The primary outcome was the time to first occurrence of the composite cardiovascular event (death due to coronary heart disease, major nonfatal coronary event or stroke).
The independent Data Safety Monitoring Board (DSMB) recommended discontinuation of the trial citing a lack of clinically meaningful efficacy, following the results of the second interim analysis. As a result of the recommendation, Roche decided to terminate the dal-OUTCOMES trial and three ongoing phase III dalcetrapib trials in the dal-HEART programme. Although the compound was not efficacious, no new safety signals were reported by the DSMB with regards to the dal-OUTCOMES trial.