Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00317395
Status:
COMPLETED
Last Update Posted:
2014-12-03
First Post:
2006-04-21
Brief Title:
Study of Otamixaban Versus Unfractionated Heparin UFH and Eptifibatide in Non-ST Elevation Acute Coronary Syndrome
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Randomized Double-blind Triple-dummy Dose-ranging Study Including an Active Control of Unfractionated Heparin and Eptifibatide to Evaluate the Clinical Efficacy and Safety of Otamixaban in Patients With Non-ST Elevation Acute Coronary Syndrome and Planned Early Invasive Strategy
Status:
COMPLETED
Status Verified Date:
2014-11
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:
SEPIA-ACS1
Brief Summary:
Primary objective To demonstrate the clinical efficacy of otamixaban dose effect via 5 intravenous IV regimens in patients with moderate-to-high-risk non-ST elevation acute coronary syndromes ACS and planned early invasive strategy
Secondary objectives To evaluate safety and assess pharmacokinetics PK and pharmacodynamics PD
Secondary objectives To evaluate safety and assess pharmacokinetics PK and pharmacodynamics PD
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 |
|---|---|---|---|
| 2006-000506-22 | EUDRACT_NUMBER | HMR | None |
| XRP0673A2003 | OTHER | None | None |