Ignite Creation Date:
2024-05-06 @ 12:08 AM
Last Modification Date:
2024-10-26 @ 10:45 AM
Study NCT ID:
NCT01499420
Status:
COMPLETED
Last Update Posted:
2014-02-06
First Post:
2011-12-19
Brief Title:
A Single Ascending Dose Study Examining the Safety and Pharmacokinetic Profile of Reconstituted High Density Lipoprotein CSL112 Administered to Patients
Sponsor:
CSL Limited
Organization:
CSL Limited
Study Overview
Official Title:
A Phase 2a Multi-center Randomized Double-blind Placebo-controlled Single Ascending Dose Study to Investigate the Safety Tolerability and Pharmacokinetics of a Single Intravenous Infusion of CSL112 in Patients With Stable Atherothrombotic Disease
Status:
COMPLETED
Status Verified Date:
2014-01
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:
None
Brief Summary:
Reconstituted high density lipoprotein used in patients with acute coronary syndrome ACS may reduce atherosclerotic plaque burden thereby reducing the risk of recurrent cardiovascular events This study is a multi-center randomized placebo-controlled single ascending dose study in patients with stable atherothrombotic disease in whom the safety and pharmacokinetic profile of CSL112 will be assessed
Detailed Description:
None
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