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ARIXTRA infusion

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment240

FDA Designations

No designations recorded

Clinical trial landscape

ARIXTRA infusion · 1 trial · 3 indications

Phase 3 1
NCT00328939ARIXTRA Local Study For Registration In China.Thromboembolism
COMPLETED240 Analytics
PHASE3COMPLETED
ARIXTRA Local Study For Registration In China.
ThromboembolismUnlock trial analytics

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 to 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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Frequently asked questions about ARIXTRA infusion

What is ARIXTRA infusion used for?

ARIXTRA infusion is a small molecule drug in Phase 3 clinical development for the treatment of thromboembolism, a condition involving blood clots. It is being studied in patients undergoing knee or hip replacement surgery. The drug is administered as an infusion and is intended to address cardiovascular conditions related to abnormal blood clotting.

Who makes ARIXTRA infusion?

ARIXTRA infusion is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker symbol GSK. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for the treatment of thromboembolism in patients undergoing joint replacement surgery.

What phase is ARIXTRA infusion in?

ARIXTRA infusion is currently in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial, which has been completed, was designed to evaluate the drug's efficacy and safety in patients with thromboembolism undergoing knee or hip replacement surgery.

What clinical trials is ARIXTRA infusion in?

ARIXTRA infusion has one completed Phase 3 clinical trial registered under the identifier NCT00328939. The trial, titled 'ARIXTRA Local Study For Registration In China,' enrolled 240 participants with thromboembolism, knee replacement, or hip replacement conditions. The study was conducted in China and included adults aged 18 years and older.

Is ARIXTRA infusion the same as fondaparinux?

ARIXTRA infusion is a brand name for the drug fondaparinux, an anticoagulant used to prevent and treat blood clots. It is a synthetic small molecule that inhibits factor Xa, a key protein in the blood clotting cascade. The drug is administered as an infusion and is being studied for thromboembolism in patients undergoing knee or hip replacement surgery.