Otamixaban drug pipeline management - clinical trial progress for drugs in development

Clinical Trials for Otamixaban

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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.
Trial ID	Title	Status	Sponsor	Phase	Summary