Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00455546
Status:
COMPLETED
Last Update Posted:
2010-02-02
First Post:
2007-03-30
Brief Title:
PLASMA Trial A Dose-Response Study of A-002 In Subjects With Stable Coronary Artery Disease
Sponsor:
Anthera Pharmaceuticals
Organization:
Anthera Pharmaceuticals
Study Overview
Official Title:
PLASMA Trial Phospholipase Levels And Serological Markers of Atherosclerosis A Dose-Response Clinical Pharmacology Study of A-002 In Subjects With Stable Coronary Artery Disease
Status:
COMPLETED
Status Verified Date:
2008-01
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:
PLASMA
Brief Summary:
The study will be conducted at up to 80 centers worldwide and will be a double-blind randomized parallel group placebo controlled study among subjects with stable coronary artery disease CAD Subjects will be randomized to receive either placebo tablets or one of 4 orally active doses of A-002 The duration of study drug therapy will be 8 weeks
Detailed Description:
A-002 represents a novel therapy for the treatment of atherosclerosis and coronary artery disease CAD Through the inhibition of activity A-002 may provide multifunctional activity directed against key facets of the disease process namely a inflammation b atherogenic lipid profiles and c the atherosclerotic process Non-clinical and clinical data from recent studies have demonstrated the benefit of early and aggressive anti-inflammatory therapy to reduce cardiovascular risk Recent clinical studies have provided a strong association between levels and cardiovascular event risk The proposed Phase 2 clinical pharmacology study Study No AN-CVD-2221 will examine the effects of 4 different doses of A-002 compared with placebo on enzyme levels and activity after 8 weeks of treatment In addition the effect of treatment on inflammatory markers of cardiovascular risk C-reactive protein CRP lipid levels and lipoprotein subclasses and other soluble biomarkers eg ICAM-1 VCAM-1 TNF MCP-1 etc will also be assessed
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