GSK initiates large-scale darapladib CHD trial

UK drug major GlaxoSmithKline has initiated the pivotal Phase III STABILITY study to evaluate the efficacy of long-term treatment with the  investigational Lp-PLA2 inhibitor, darapladib, in chronic coronary heart  disease.

STABILITY is a randomized, placebo-controlled, double-blind,  parallel-group, multicenter, event-driven trial in men and women with  chronic CHD. The study will evaluate the clinical efficacy of long-term  treatment with darapladib compared with placebo on the incidence of  first occurrence of major adverse cardiovascular events, including CV  death, non-fatal heart attack and non-fatal stroke.

Patients will be randomized 1:1 to once-daily treatment with darapladib  or placebo. The duration of the study will be determined by the rate of  first occurrence of events that comprise the primary endpoint of MACE.  The study will be stopped when approximately 1,500 reports of first  occurrence of MACE have occurred - estimated to be approximately three  years - with interim independent analyses planned.