CLINICAL TRIALS PROFILE FOR OTAMIXABAN

Clinical Trials for Otamixaban

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT00133731 ↗	The SEPIA-PCI Trial: Otamixaban in Comparison to Heparin in Subjects Undergoing Non-Urgent Percutaneous Coronary Intervention	Completed	Sanofi	Phase 2	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), safety/tolerability, clinical efficacy and pharmacokinetics.
NCT00317395 ↗	Study of Otamixaban Versus Unfractionated Heparin (UFH) and Eptifibatide in Non-ST Elevation Acute Coronary Syndrome	Completed	Sanofi	Phase 2	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).
NCT01076764 ↗	Effect of Otamixaban Versus Unfractionated Heparin + Eptifibatide in Patients With Unstable Angina/Non ST Elevation Myocardial Infarction Undergoing Early Invasive Strategy	Completed	Sanofi	Phase 3	Primary Objective: - To demonstrate the superior efficacy (composite of all-cause death + Myocardial Infarction (MI)) of Otamixaban to Unfractionated Heparin (UFH) + Eptifibatide Secondary Objectives: - To demonstrate the superior efficacy (composite of all-cause death + MI + any stroke) of Otamixaban as compared to UFH + Eptifibatide - To document the effect of Otamixaban on rehospitalization or prolongation of hospitalization due to a new episode of myocardial ischemia/myocardial infarction as compared to UFH + eptifibatide - To document the effect on mortality (all cause death) of Otamixaban as compared to UFH + eptifibatide - To document the safety of Otamixaban as compared to UFH + eptifibatide - To document the effect of Otamixaban on thrombotic procedural complications during the index Percutaneous Coronary Intervention (PCI) as compared to UFH + eptifibatide
NCT01120314 ↗	Pharmacokinetic, Pharmacodynamic and Tolerability Study of Otamixaban in Patients With Mild, Moderate and Severe Renal Impairment	Completed	Sanofi	Phase 1	Primary Objective: - To study effect of mild, moderate and severe renal impairment on the pharmacokinetics of Otamixaban. Secondary Objective: - To assess the pharmacodynamic effects of Otamixaban on subjects with mild, moderate and severe renal impairment and in matched subjects with normal renal function.
NCT01126086 ↗	Pharmacokinetic, Pharmacodynamic and Tolerability Study of Otamixaban in Patients With Mild and Moderate Hepatic Impairment	Completed	Sanofi	Phase 1	Primary Objective: - To study effect of mild and moderate hepatic impairment on the pharmacokinetics of otamixaban. Secondary Objective: - To assess the pharmacodynamic effects of otamixaban on subjects with mild and moderate hepatic impairment and in matched subjects with normal hepatic function.

Clinical Trial Conditions for Otamixaban

Condition Name

Condition Name
Intervention	Trials
Coronary Disease	1
Hepatic Impairment	1
Renal Impairment	1
Acute Coronary Syndrome	1

Condition MeSH

Condition MeSH
Intervention	Trials
Acute Coronary Syndrome	2
Coronary Disease	1
Coronary Artery Disease	1
Liver Diseases	1

Clinical Trial Locations for Otamixaban

Trials by Country

Trials by Country
Location	Trials
United States	59
Canada	6
France	4
Slovakia	3
Czech Republic	3

Trials by US State

Trials by US State
Location	Trials
Florida	4
Minnesota	3
Tennessee	3
Wisconsin	2
Virginia	2

Clinical Trial Progress for Otamixaban

Clinical Trial Phase

Clinical Trial Phase
Clinical Trial Phase	Trials
Phase 3	1
Phase 2	2
Phase 1	2

Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase	Trials
Completed	5

Clinical Trial Sponsors for Otamixaban

Sponsor Name

Sponsor Name
Sponsor	Trials
Sanofi	5

Sponsor Type

Sponsor Type
Sponsor	Trials
Industry	5