A Phase II Clinical Study of SB-480848 in Dyslipidemic Patients

Summary

The primary objective of this study is to examine the effects of SB-480848 on plasma lipoprotein associated phospholipase A2 (Lp-PLA2) activity in dyslipidemic patients during a 4-week treatment with SB-480848.

Timeline

Start

2008-08-26

Primary completion

2009-01-16

Completion

2009-01-16

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs SB-480848 40 mg; p <.001; Ratio 0.514 (95% CI 0.449 to 0.590); ANCOVA NCT00734032 ↗

registry analysis (superiority test); Placebo vs SB-480848 80 mg; p <.001; Ratio 0.421 (95% CI 0.367 to 0.483); ANCOVA NCT00734032 ↗

registry analysis (superiority test); Placebo vs SB-480848 160 mg; p <.001; Ratio 0.326 (95% CI 0.284 to 0.375); ANCOVA NCT00734032 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Darapladib	Small molecule	40 mg	—
Subject	Darapladib	Small molecule	80 mg	—
Subject	Darapladib	Small molecule	160 mg	—

Indications