Integrated Biomarker And Imaging Study - 2

Summary

IBIS-2 is a study using SB-480848 versus placebo in subjects with angiographically documented coronary heart disease. Endpoints include coronary imaging, endothelial function, biomarkers, safety and tolerability.

Timeline

Start

2005-11-10

Primary completion

2007-08-28

Completion

2007-08-28

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Placebo vs Darapladib 160 mg EC Tablet; p = 0.348; Adjusted percentage change -11.717 (95% CI -31.995 to 14.607); ANCOVA NCT00268996 ↗

registry analysis (superiority or other test); Placebo vs Darapladib 160 mg EC Tablet; p = 0.220; Adjusted Treatment Difference -0.082 (95% CI -0.214 to 0.049); ANCOVA NCT00268996 ↗

Publications

• Background Serruys PW, Garcia-Garcia HM, Buszman P, Erne P, Verheye S, Aschermann M, Duckers H, Bleie O, Dudek D, Botker HE, von Birgelen C, D'Amico D, Hutchinson T, Zambanini A, Mastik F, van Es GA, van der Steen AF, Vince DG, Ganz P, Hamm CW, Wijns W, Zalewski A; Integrated Biomarker and Imaging Study-2 Investigators. Effects of the direct lipoprotein-associated phospholipase A(2) inhibitor darapladib on human coronary atherosclerotic plaque. Circulation. 2008 Sep 9;118(11):1172-82. doi: 10.1161/CIRCULATIONAHA.108.771899. Epub 2008 Sep 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Darapladib	Small molecule	160 mg	—

Indications