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Last Updated: March 29, 2024

CLINICAL TRIALS PROFILE FOR OTAMIXABAN


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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.
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for Otamixaban

Condition Name

Condition Name for
Intervention Trials
Hepatic Impairment 1
Renal Impairment 1
Acute Coronary Syndrome 1
Angioplasty, Transluminal, Percutaneous Coronary 1
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Condition MeSH

Condition MeSH for
Intervention Trials
Acute Coronary Syndrome 2
Liver Diseases 1
Renal Insufficiency 1
Myocardial Infarction 1
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Clinical Trial Locations for Otamixaban

Trials by Country

Trials by Country for
Location Trials
United States 59
Canada 6
France 4
Germany 3
South Africa 3
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Trials by US State

Trials by US State for
Location Trials
Florida 4
Minnesota 3
Tennessee 3
Ohio 2
Illinois 2
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Clinical Trial Progress for Otamixaban

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 3 1
Phase 2 2
Phase 1 2
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Completed 5
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Clinical Trial Sponsors for Otamixaban

Sponsor Name

Sponsor Name for
Sponsor Trials
Sanofi 5
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Sponsor Type

Sponsor Type for
Sponsor Trials
Industry 5
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