Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00133731
Status:
COMPLETED
Last Update Posted:
2008-07-02
First Post:
2005-08-23
Brief Title:
The SEPIA-PCI Trial Otamixaban in Comparison to Heparin in Subjects Undergoing Non-Urgent Percutaneous Coronary Intervention
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Multinational Randomized Double-Blind Double-Dummy Exploratory Parallel Group Dose-Ranging Phase II Study to Evaluate Pharmacodynamics Safety and Tolerability and Pharmacokinetics of Several Intravenous Regimens of Factor Xa Inhibitor Otamixaban XRP0673 in Comparison to Intravenous Unfractionated Heparin in Subjects Undergoing Non-Urgent Percutaneous Coronary Intervention
Status:
COMPLETED
Status Verified Date:
2008-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SEPIA-PCI
Brief Summary:
The objective of this dose-ranging study is to determine the effects of several intravenous IV regimens of otamixaban on pharmacodynamic markers including markers of thrombosis and coagulation markers safetytolerability clinical efficacy and pharmacokinetics
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| XRP0673 | None | None | None |