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Last Updated: February 12, 2025

CLINICAL TRIALS PROFILE FOR ARIXTRA


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All Clinical Trials for Arixtra

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00060554 ↗ A Safety and Efficacy Trial Evaluating the Use of Fondaparinux in Percutaneous Coronary Intervention (PCI)(63133)(WITHDRAWN) Withdrawn Schering-Plough Phase 2 2003-04-01 The purpose of this research study is to obtain experience in the use of fondaparinux (Arixtra) as compared to heparin when administered to patients who undergo percutaneous coronary intervention (PCI). PCI is a mechanical procedure used to widen the narrowing in a coronary artery in patients with symptomatic coronary artery disease. Fondaparinux and heparin are drugs that inhibit blood clotting.
NCT00256100 ↗ Fondaparinux as an Anticoagulant in Haemofiltration in Patients With Acute Kidney Failure. Terminated Melbourne Health N/A 2004-06-01 The purpose of this project is to assess the safety and effectiveness of fondaparinux, a new drug to prevent blood clotting in the continuous dialysis machine used in intensive care patients who have kidney failure.
NCT00328939 ↗ ARIXTRA Local Study For Registration In China. Completed GlaxoSmithKline Phase 3 2004-05-01 This is a local registration study in China to compare the safety and efficacy of ARIXTRA to Enoxaparine in patients undergoing elective major hip or knee replacement or a revision of components.
NCT00412464 ↗ Pilot Dose Finding and Pharmacokinetic Study of Fondaparinux in Children With Thrombosis Completed Children's Hospital Los Angeles Phase 1 2006-09-01 This study will evaluate the use of a blood thinner, fondaparinux, which is approved for use in adults (not in children) in a children aged 1-18 years. Subject with a blood clot (thrombosis) or heparin-induced thrombocytopenia who need to be on a blood thinner will be eligible to participate. Subjects will receive a once daily dose of fondaparinux followed by blood tests at 2, 4, 12, and 24 hours after the first dose in order to determine the proper dose for this age group. The hypothesis is that children receiving fondaparinux will be able to receive a once daily dose. The currently available alternative agent, enoxaparin, needs to be given twice daily. In addition, an evaluation of the safety of this medication will be made by assessing for side effects, especially bleeding.
NCT00423683 ↗ Anticoagulation and Inferior Vena Cava Filters in Cancer Patients With a Venous Thromboembolism Terminated GlaxoSmithKline Phase 3 2007-01-01 The development of clots is a potentially deadly complication in many cancer patients. The current optimal treatment is unknown. Evidence supporting the effectiveness of the use of Inferior Vena Caval Filters is lacking. This study will compare the two standard of care treatment options: anticoagulation with or without a inferior vena cava filter. The anticoagulation medication chosen will be Arixtra and it will be given once a day as an injection. Patients will be called at various intervals to monitor their signs and symptoms of new thromboembolisms.
NCT00423683 ↗ Anticoagulation and Inferior Vena Cava Filters in Cancer Patients With a Venous Thromboembolism Terminated Northwell Health Phase 3 2007-01-01 The development of clots is a potentially deadly complication in many cancer patients. The current optimal treatment is unknown. Evidence supporting the effectiveness of the use of Inferior Vena Caval Filters is lacking. This study will compare the two standard of care treatment options: anticoagulation with or without a inferior vena cava filter. The anticoagulation medication chosen will be Arixtra and it will be given once a day as an injection. Patients will be called at various intervals to monitor their signs and symptoms of new thromboembolisms.
NCT00424281 ↗ Effectiveness of Blood Clot Medication With Concomitant Blood Pressure Medication Unknown status GlaxoSmithKline 2007-02-01 Patients in intensive care units have higher risks for developing blood clots. Arixtra inhibits blood clot formation by binding with the blood clotting factor, Xa. Critical illnesses and, specifically, medications given in the ICU to increase arterial blood pressure (vasopressors) may impair the absorption of drugs like Arixtra that are given subcutaneously. The study will measure the levels of Arixtra in blood comparing those subjects who are and those subjects who are not on blood pressure medication.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Arixtra

Condition Name

Condition Name for Arixtra
Intervention Trials
Venous Thromboembolism 6
Pulmonary Embolism 4
Heparin-Induced Thrombocytopenia 3
Thrombosis, Venous 3
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Condition MeSH

Condition MeSH for Arixtra
Intervention Trials
Thromboembolism 12
Venous Thromboembolism 12
Thrombosis 12
Venous Thrombosis 10
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Clinical Trial Locations for Arixtra

Trials by Country

Trials by Country for Arixtra
Location Trials
United States 62
Germany 26
Italy 10
Canada 7
China 7
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Trials by US State

Trials by US State for Arixtra
Location Trials
New York 5
Michigan 4
North Carolina 4
California 4
Massachusetts 3
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Clinical Trial Progress for Arixtra

Clinical Trial Phase

Clinical Trial Phase for Arixtra
Clinical Trial Phase Trials
Phase 4 7
Phase 3 7
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Arixtra
Clinical Trial Phase Trials
Completed 24
Terminated 8
Withdrawn 4
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Clinical Trial Sponsors for Arixtra

Sponsor Name

Sponsor Name for Arixtra
Sponsor Trials
GlaxoSmithKline 23
Wayne State University 2
James Graham Brown Cancer Center 2
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Sponsor Type

Sponsor Type for Arixtra
Sponsor Trials
Other 37
Industry 26
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ARIXTRA: Clinical Trials, Market Analysis, and Projections

Introduction to ARIXTRA

ARIXTRA, also known as fondaparinux sodium, is an anticoagulant medication used to prevent and treat venous thromboembolic (VTE) events, including deep vein thrombosis (DVT) and pulmonary embolism (PE). It is also investigated for its efficacy in acute coronary syndromes (ACS).

Clinical Trials Overview

Venous Thromboembolism Prevention

ARIXTRA has been extensively studied in various clinical trials for the prevention of VTE in surgical patients. In a randomized, double-blind trial involving patients undergoing knee replacement surgery, ARIXTRA demonstrated a significant reduction in VTE rates compared to enoxaparin sodium. The trial showed a VTE rate of 12.5% for ARIXTRA versus 27.8% for enoxaparin sodium, resulting in a relative risk reduction of 55%[1].

In another study, ARIXTRA was compared to enoxaparin sodium in patients with acute symptomatic DVT without pulmonary embolism. The results indicated that ARIXTRA had a VTE rate of 8.3% compared to 19.1% for enoxaparin sodium[1].

Acute Coronary Syndromes

ARIXTRA has also been evaluated in the treatment of acute coronary syndromes. The OASIS 5 and OASIS 6 trials, which involved over 20,000 patients, compared ARIXTRA to enoxaparin and standard therapies, respectively. These trials showed that ARIXTRA reduced the risk of death or another heart attack by 14% after 30 days in patients with ST-segment elevation myocardial infarction (STEMI)[3][4].

Market Analysis

Global Market Overview

The global ARIXTRA market has been analyzed in terms of consumption volume, value, and growth rate. The market research report from 2013 to 2025 provides insights into the market dynamics, including mergers, acquisitions, and new investments. The report segments the market by types, applications, and regions, offering a comprehensive view of the global ARIXTRA market[2].

Regional Market Analysis

  • United States: The U.S. market for ARIXTRA has seen significant consumption and revenue growth. The report details sales volume by competitive vendors and consumption structure by applications[2].
  • Europe: European markets, including Germany, the UK, France, Italy, Spain, Poland, and Russia, have also shown substantial consumption volumes. The report provides detailed analysis by types and applications[2].
  • Asia-Pacific: Countries like China, Japan, and Southeast Asian nations have contributed to the global market growth. The report highlights consumption volumes and value analysis for these regions[2].

Market Dynamics and Development

The market is driven by several factors, including the increasing incidence of VTE and ACS, advancements in anticoagulant therapies, and expanding healthcare infrastructure. However, limitations such as high costs and potential bleeding risks also influence market dynamics[2].

Market Projections

Global Consumption and Value Forecast

The global ARIXTRA market is projected to grow significantly from 2018 to 2025. The forecast includes consumption volume, value, and growth rate by regions and types. The report predicts continued demand driven by the need for effective anticoagulant therapies in various clinical settings[2].

Price and Trend Forecast

The price trends for ARIXTRA are expected to stabilize with minor fluctuations, influenced by market competition and regulatory environments. The forecast also includes revenue and price projections by type and application[2].

Competitive Landscape

The global ARIXTRA market is competitive, with GlaxoSmithKline (GSK) being the primary manufacturer. Other anticoagulant drugs like enoxaparin sodium and dalteparin also compete in the market. The competitive landscape is shaped by ongoing research, new product approvals, and strategic partnerships[2][3].

Key Applications and Indications

  • Prevention of VTE: ARIXTRA is approved for the prevention of VTE in patients undergoing surgery for hip fracture, knee replacement, hip replacement, and abdominal surgery[3].
  • Treatment of DVT and PE: It is indicated for the treatment of acute DVT and PE when administered in conjunction with warfarin sodium[3].
  • Acute Coronary Syndromes: Although not currently approved for ACS, positive results from Phase III trials suggest potential future indications[3].

Safety and Efficacy

ARIXTRA has demonstrated efficacy in reducing VTE rates and improving outcomes in ACS patients. However, it also carries risks such as major bleeding episodes, which occurred in 2.1% of ARIXTRA patients in some studies[1][4].

"ARIXTRA is at least as effective as the comparator in preventing thrombotic events," - European Medicines Agency[4].

Conclusion

ARIXTRA is a significant player in the anticoagulant market, backed by robust clinical trials and a strong market presence. Its efficacy in preventing VTE and potential benefits in ACS make it a valuable treatment option. As the market continues to grow, ARIXTRA is expected to remain a key drug in the management of thromboembolic events.

Key Takeaways

  • ARIXTRA has shown superior efficacy in preventing VTE compared to other anticoagulants in several clinical trials.
  • The drug has potential benefits in treating acute coronary syndromes, as indicated by Phase III trials.
  • The global market for ARIXTRA is projected to grow, driven by increasing demand for effective anticoagulant therapies.
  • ARIXTRA is approved for various indications, including the prevention of VTE in surgical patients and the treatment of DVT and PE.
  • The drug carries risks such as major bleeding episodes, which need to be carefully managed.

Frequently Asked Questions (FAQs)

What is ARIXTRA used for?

ARIXTRA is used for the prevention of venous thromboembolic events (VTE) in surgical patients and the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE).

How does ARIXTRA compare to other anticoagulants?

ARIXTRA has been shown to be more effective than enoxaparin sodium in reducing VTE rates in several clinical trials.

What are the potential risks associated with ARIXTRA?

The potential risks include major bleeding episodes, which occurred in 2.1% of ARIXTRA patients in some studies.

Is ARIXTRA approved for acute coronary syndromes?

No, ARIXTRA is not currently approved for acute coronary syndromes, although it has shown promising results in Phase III trials.

What regions are driving the growth of the ARIXTRA market?

The growth of the ARIXTRA market is driven by regions such as the United States, Europe, China, Japan, and Southeast Asia.

Cited Sources

  1. ARIXTRA® - accessdata.fda.gov
  2. Global Arixtra Consumption Market Research Report 2013-2025 of Major Types, Applications, and Competitive Vendors in Top Regions and Countries - maiaresearch.com
  3. FDA Grants Priority Review For GlaxoSmithKline's ARIXTRA(R) - biospace.com
  4. Arixtra | European Medicines Agency (EMA) - ema.europa.eu

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