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ARIXTRA infusion

Phase 3

Thromboembolism | Small molecule | Other |GSK plc|Last Updated: Jun 4, 2012

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedUNCONTROLLED
Total Trials1
Total Enrollment240
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00328939ARIXTRA Local Study For Registration In China.PHASE3 COMPLETED 240May 1, 2004 -Jun 4, 20127 China
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Study Endpoints
Primary Endpoints
Occurrence of overall DVT (deep vein thrombosis) events confirmed by ultrasound result within day 5-11 post operation.
Secondary Endpoints
Occurrence of DVT with symptom and non-fatal PE (pulmonary embolism). Occurrence of fatal PE.
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION
Interventions
NameTypeDescription
ARIXTRA infusionDRUG -
Enoxaparine infusionDRUG -
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion criteria: * Patients undergoing either an elective major hip or knee replacement or revision. * Signed written informed consent. Men or women of non-child bearing potential(i.e., post menopausal or with hysterectomy of bilateral tubule ligation) or women of childbearing potential without ...

Countries:China
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