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SR123781A

Phase 2

Venous Thromboembolism | Small molecule | Cardiovascular |Sanofi|Last Updated: Dec 10, 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment1,090

FDA Designations

No designations recorded

Clinical trial landscape

SR123781A · 1 trial · 1 indication

Phase 2 1
NCT00338897Dose Ranging Study in Elective Total Hip Replacement SurgeryVenous Thromboembolism
COMPLETED1,090 Analytics
PHASE2COMPLETED
Dose Ranging Study in Elective Total Hip Replacement Surgery
Venous Thromboembolism
NCT003388971,090
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Study Endpoints

Primary Endpoints

The primary efficacy endpoint is a composite of total venous thromboembolic events (VTE) including VTE related deaths during the treatment period.

Secondary Endpoints

Secondary efficacy endpoints will include all deep vein thrombosis events [DVTs] (proximal or distal) and all symptomatic VTEs (pulmonary embolisms [PEs] or DVTs)
The main safety criterion is the incidence of major bleedings occurring from the first study drug administration to 3 calendar days after the last study drug administration.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Interventions

NameTypeDescription
SR123781ADRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites14

Inclusion Criteria: * Patients scheduled to undergo elective total hip replacement surgery or a revision of at least one component of a total hip replacement performed \> 6 months prior to study entry Exclusion Criteria: * Pregnant or nursing women, or women of childbearing potential who are not ...

Countries:ArgentinaBulgariaChileColombiaCzechiaDenmarkFinlandMexicoNorwayPolandRomaniaRussiaSwedenTurkey (Türkiye)
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Frequently asked questions about SR123781A

What is SR123781A used for?

SR123781A is an investigational small molecule being developed for venous thromboembolism, a condition involving blood clots in veins. It has been studied in a Phase 2 clinical trial for this indication. The drug is not approved and remains in clinical development.

Who makes SR123781A?

SR123781A is being developed by Sanofi, a multinational pharmaceutical company traded on the stock exchange under the ticker SNY. The drug is currently in Phase 2 clinical development for venous thromboembolism.

What phase is SR123781A in?

SR123781A is in Phase 2 clinical development. It has completed one Phase 2 trial, which was a dose-ranging study in elective total hip replacement surgery. The drug is investigational and has not been approved for any use.

What clinical trials is SR123781A in?

SR123781A has been studied in one completed Phase 2 clinical trial, identified as NCT00338897. This was a dose-ranging study in elective total hip replacement surgery, enrolling 1090 participants across multiple countries including Argentina, Bulgaria, Chile, and others.

Is SR123781A the same as any other drug?

SR123781A is the primary name for this investigational drug. No alternative names have been reported for this compound. It is being developed by Sanofi for venous thromboembolism and is currently in Phase 2 clinical development.