Study to Determine the Effect of 14 Days Dosing With Darapladib (SB-480848) on Carotid Plague Composition in Patients With Planned Carotid Endarterectomy
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|ClinicalTrials.gov Identifier: NCT01916720|
Recruitment Status : Completed
First Posted : August 6, 2013
Last Update Posted : December 5, 2016
|Condition or disease||Intervention/treatment||Phase|
|Atherosclerosis||Drug: SB-480848 40 mg Drug: SB-480848 80 mg Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||103 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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|
|Study Start Date :||January 2003|
|Actual Primary Completion Date :||July 2003|
|Actual Study Completion Date :||July 2003|
Experimental: SB-480848 40 mg
SB-480848 40 milligrams (mg) once a day (od) for 14 +/- 4 days followed by carotid endarterectomy. SB-480848 40 mg was administered as 2 SB-480848 20 mg tablets plus 2 placebo tablets.
Drug: SB-480848 40 mg
Study DrugDrug: Placebo
Experimental: SB-480848 80 mg
SB-480848 80 mg od for 14 +/- 4 days followed by carotid endarterectomy.SB-480848 80 mg was administered as 4 20 mg SB-480848 tablets.
Drug: SB-480848 80 mg
Placebo Comparator: Matching Placebo
Placebo for 14 +/- 4 days followed by carotid endarterectomy. Placebo was administered as 4 placebo tablets. Placebo tablets were identical in appearance to the SB-480848 20 mg tablets.
- Lp-PLA2 activity in the atherosclerotic plaque removed during carotid endarterectomy [ Time Frame: 14 +/- 4 days ]
- Lp-PLA2 mass in plaque removed during the carotid endarterectomy [ Time Frame: 14 +/- 4 days ]
- Lp-PLA2 mass and activity in blood [ Time Frame: 14 +/- days ]
- Lipid and Non-Lipid Biomarkers in Plasma [ Time Frame: 14 +/- days ]Lipids: total cholesterol, HDL, LDL, and triglycerides Non-Lipids: hsCRP, CD40L, ICAM-1, E-selectin, PAI-1 antibody, PAI-1 antigen, and MMP-9
- Oxidised Lipids and Their Metabolites, and Biomarkers in Plaque [ Time Frame: 14 +/- 4 days ]Oxidised Lipids and Their Metabolites: total lyso-PC, total phospholipid, and total phosphatidylcholine Biomarkers: CD68 (macrophages), CD3 (T cells), CD20 or CD22 (B cells), alpha-actin (smooth muscle cells), CD40L, MMP-2, MMP-9, PAI-1, ICAM-1, IL-6, and Lp-PLA2 (mRNA expression)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01916720
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|