Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00269048
Status:
COMPLETED
Last Update Posted:
2016-08-08
First Post:
2005-12-21
Brief Title:
SB-480848 In Subjects With Coronary Heart Disease
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Multicenter Randomized Double-blind Placebo-controlled Parallel-group Dose-ranging Study of SB-480848 an Oral Lipoprotein-associated Phospholipase A2 Lp-PLA2 Inhibitor in Subjects With Stable Coronary Heart Disease CHD or CHD-risk Equivalent to Examine Chronic Inhibition of Lp-PLA2 Effects on Circulating Biomarkers Associated With Cardiovascular Risk Safety and Tolerability Over 12 Weeks
Status:
COMPLETED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This trial of SB-480848 in approximately 920 subjects with Coronary Heart Disease CHD or CHD-risk equivalent will examine whether SB-480848 produces sustained inhibition of plasma Lp-PLA2 activity explore the effects of SB-480848 on other circulating biomarkers associated with cardiovascular risk and evaluate the pharmacokinetics safety and tolerability of SB-480848 over 12 weeks of once-daily oral dosing Subjects will first be randomized 11 to double-blind atorvastatin 20 mg or 80 mg once daily for a minimum of 3 weeks Subjects will then be randomized 1111 to oral doses of SB-480848 40 mg 80 mg 160 mg or placebo once daily for 12 weeks Blood samples will be collected at various timepoints Vital signs electrocardiograms clinical laboratory safety tests and adverse event assessments will be performed to evaluate the safety and tolerability of SB-480848
Detailed Description:
A multicenter randomized double-blind placebo-controlled parallel-group dose-ranging study of SB-480848 an oral lipoprotein-associated phospholipase A2 Lp-PLA2 inhibitor in subjects with stable coronary heart disease CHD or CHD-risk equivalent to examine chronic inhibition of Lp-PLA2 effects on circulating biomarkers associated with cardiovascular risk safety and tolerability over 12 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None