Ignite Creation Date:
2025-12-24 @ 2:20 PM
Ignite Modification Date:
2025-12-26 @ 1:26 PM
Study NCT ID:
NCT00317395
Status:
COMPLETED
Last Update Posted:
2014-12-03
First Post:
2006-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Otamixaban Versus Unfractionated Heparin (UFH) and Eptifibatide in Non-ST Elevation Acute Coronary Syndrome
Sponsor:
Sanofi
Organization:
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:
True
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?: