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Rivaroxaban Xarelto, BAY59-7939

Phase 1

Thrombosis | Small molecule | Cardiovascular |Bayer AG|Last Updated: Apr 16, 2019

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment47

FDA Designations

No designations recorded

Clinical trial landscape

Rivaroxaban Xarelto, BAY59-7939 · 1 trial · 1 indication

Phase 1 1
NCT02497716Phase I Study on Rivaroxaban Granules for Oral Suspension Formulation in ChildrenThrombosis
COMPLETED47 Analytics
PHASE1COMPLETED
Phase I Study on Rivaroxaban Granules for Oral Suspension Formulation in Children
Thrombosis
NCT0249771647
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Study Endpoints

Primary Endpoints

AUC (area under the curve)
4x within 8 hrs post study drug administrationh and 1x between 24-28h after administration

Only PK will be tested in central lab

Cmax (maximum observed drug concentration)
4x within 8 hrs post study drug administrationh and 1x between 24-28h after administration

Only PK will be tested in central lab

Secondary Endpoints

Prothrombin time (PT)
Pre-administration, if not done within the past 10 days, and then 24-28 hours after drug administration
Activated partial thromboplastin time (aPTT)
Pre-administration, if not done within the past 10 days, and then 24-28 hours after drug administration
Composite of major bleeding and clinically relevant non-major bleeding
From dose administration until follow up call on day 8+3
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER

Treatment Arms

ArmTypeDescription
RivaroxabanEXPERIMENTALSingle arm, open label study

Interventions

NameTypeDescription
Rivaroxaban (Xarelto, BAY59-7939DRUGSingle dose of reconstituted rivaroxaban granules
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Eligibility Criteria

Age Range2 Months to 12 Years
SexALL
Healthy VolunteersNo
Study Sites21

Inclusion Criteria: * Children with an age ≥2 months and weight between 3 and \<12 kg, who have completed anticoagulant treatment at least 10 days prior to the planned study drug administration. * Gestational age at birth of at least 37 weeks * Oral feeding/ nasogastric/ gastric feeding for at...

Countries:United StatesBelgiumCanadaFinlandFranceHungaryItalySpain
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Competitive Landscape -Thrombosis and Embolism 22 trials (matched to "Thrombosis")

CompanyTickerTrialsLead PhaseDrugs
Regeneron Pharmaceuticals, Inc.REGN3PHASE3REGN7508, Apixaban, Enoxaparin
Merit Medical Systems, Inc.MMSI4 - Undisclosed
AtriCure, Inc.ATRC1N/AUndisclosed
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE2Thrombate infusion
Penumbra, Inc.PEN1N/AUndisclosed
LeMaitre Vascular, Inc.LMAT2N/AUndisclosed
Abbott LaboratoriesABT1 - Undisclosed
Novo Nordisk A/S Sponsored ADR Class BNVO1 - Undisclosed
Boston Scientific CorporationBSX1N/AUndisclosed
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Frequently asked questions about Rivaroxaban Xarelto, BAY59-7939

What is Rivaroxaban Xarelto used for?

Rivaroxaban Xarelto, also known as BAY59-7939, is a small molecule being developed for the treatment of thrombosis, a condition involving blood clot formation. It is being studied in the cardiovascular therapeutic area. The drug is currently in clinical development for this indication.

Who makes Rivaroxaban Xarelto?

Rivaroxaban Xarelto is being developed by Bayer AG, a pharmaceutical company. Bayer AG is publicly traded under the ticker symbol BAYRY. The company is conducting clinical research on this drug for the treatment of thrombosis.

What phase is Rivaroxaban Xarelto in?

Rivaroxaban Xarelto is currently in Phase 1 clinical development. It is an investigational drug being studied for the treatment of thrombosis. The drug has not yet completed the full clinical development process required for regulatory approval.

What clinical trials is Rivaroxaban Xarelto in?

Rivaroxaban Xarelto has been studied in a completed Phase 1 clinical trial with the identifier NCT02497716. This trial investigated the drug in a granule formulation for oral suspension in children with thrombosis. The study enrolled 47 participants across multiple countries including the United States, Belgium, Canada, Finland, France, Hungary, Italy, and Spain.

Is Rivaroxaban Xarelto the same as BAY59-7939?

Yes, Rivaroxaban Xarelto is also known as BAY59-7939. These names refer to the same drug substance. The drug is being developed by Bayer AG for the treatment of thrombosis and is currently in Phase 1 clinical development.