Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00312052
Status:
COMPLETED
Last Update Posted:
2016-12-05
First Post:
2006-04-05
Brief Title:
Safety and Tolerability of E5555 and Its Effects on Markers of Intravascular Inflammation in Subjects With Coronary Artery Disease
Sponsor:
Eisai Inc
Organization:
Eisai Inc
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Study of the Safety and Tolerability of E5555 and Its Effects on Markers of Intravascular Inflammation in Subjects With Coronary Artery Disease
Status:
COMPLETED
Status Verified Date:
2016-11
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:
The primary purpose of this study is to assess the safety and tolerability of E5555 in subjects with coronary artery disease
Detailed Description:
This was a multicenter randomized double-blind placebo-controlled trial of E5555 a PAR-1 inhibitor The total duration of individual study participation was 28 weeks 196 days This included a treatment period of 24 weeks 168 days and a follow-up period of 4 weeks 28 days
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2005-006029-94 | EUDRACT_NUMBER | None | None |