Who is sponsoring NCT01916720?

NCT01916720 is sponsored by GlaxoSmithKline.

What condition does NCT01916720 study?

NCT01916720 studies Atherosclerosis.

What drugs are being tested in NCT01916720?

Interventions: SB-480848 40 mg, SB-480848 80 mg, Placebo.

What is the status of NCT01916720?

NCT01916720 is currently COMPLETED.

Last reviewed 2016-12-02 · How we verify

A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel-group Study to Investigate the Effect of the Lp-PLA2 Inhibitor SB-480848 (40, 80mg od) on Carotid Plaque Composition in Patients With Carotid Artery Disease and Planned Carotid Endarterectomy, Stratified for Statin Use and Gender, After 14+/-4 Days Treatment

NCT01916720 Phase 2 COMPLETED

The primary objective is to determine Lp-PLA2 activity in atherosclerotic carotid plaques after 14 (+/-4) days treatment with darapladib, compared to placebo. Secondary objectives include determination of the change in Lp-PLA2 activity in blood, Lp-PLA2 mass in blood and plaque, specified biomarkers in blood and plaque and their respective correlation's with Lp-PLA2. In addition, the study aims to characterise the PK/PD of repeat oral doses of SB-480848, and safety and tolerability in this population.

Details

Lead sponsor	GlaxoSmithKline
Phase	Phase 2
Status	COMPLETED
Enrolment	103
Start date	2003-01
Completion	2003-07

Conditions

Atherosclerosis

Interventions

SB-480848 40 mg
SB-480848 80 mg
Placebo

Primary outcomes

Lp-PLA2 activity in the atherosclerotic plaque removed during carotid endarterectomy — 14 +/- 4 days