Fondaparinux has been approved in the United States and in the European Union and in the Other Countries

Studies listed may include approved and non-approved uses, formulations or treatment regimens. Before prescribing any product mentioned in this Register, healthcare Professionals should consult prescribing information approved in their country (view UK and US information for Healthcare Professionals).

The summaries are in PDF format. If you do not have Adobe® Acrobat® Reader™ installed, you can download it for free.


fondaparinux studies

Select the study ID number to view the trial summary

Study IDPhaseTitle
L_8598 IV Fondaparinux sodium in ORthopaedic SurgEry (FORSE): A Prospective Evaluation of ArixtraTM for the Prevention of Symptomatic Venous Thromboembolism in Orthopaedic Surgery
L8518 IV Flexibility in administration of Arixtra for prevention of symptomatic venous thromboembolism in orthopedic surgery
63118 III European Pentasaccharide Hip Elective Surgery Study (EPHESUS): A multicenter, randomized, double-blind comparison of once daily subcutaneous Org31540/SR90107A with enoxaparin for the prevention of deep vein thrombosis or symptomatic pulmonary embolism in patients undergoing elective hip replacement surgery.
63123 III A multicentre, randomized, open-label study comparing the efficacy and safety of once daily (o.d.) Org31540/SR90107A versus adjusted dose intravenous (i.v.) unfractionated heparin (UFH) in the initial treatment of acute symptomatic pulmonary embolism (PE) (MATISSE-PE)
63129 III A multinational, randomized, double-blind comparison of once daily subcutaneous fondaparinux sodium with placebo for the prevention of venous thromboembolic events in acutely ill medical patients (ARTEMIS).
095-002 III A multicenter, multinational, randomized, double-blind comparison of subcutaneous Org31540/SR90107A with enoxaparin in the prevention of deep vein thrombosis and symptomatic pulmonary embolism after elective major knee surgery or a revision (PENTAMAKS).
AR1103420 III An International, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Fondaparinux versus Enoxaparin in the Acute Treatment of Unstable Angina /Non ST-Segment Elevation MI Acute Coronary Syndromes
AR2103413 III An International Randomized Study Evaluating the Efficacy and Safety of Fondaparinux Sodium Versus Control Therapy in a Broad Range Of Subjects With ST Segment Elevation Acute Myocardial Infarction.
AR3103414 III A multicenter, randomized, double-blind, parallel group trial to demonstrate the efficacy of fondaparinux sodium in association with Intermittent Pneumatic Compression versus Intermittent Pneumatic Compression used alone for the prevention of venous thromboembolic events in subjects at increased risk undergoing major abdominal surgery (APOLLO)
C8843 III Multinational/multicentre, non-randomized, open label study to assess efficacy and safety of fondaparinux sodium (ARIXTRAÒ) use in daily practice in subjects undergoing major orthopedic surgery of the lower limbs
DRI4090 III A multicenter, randomized, double-blind, placebo controlled, parallel group, dose response study of subcutaneous Org31540/SR90107A in the prevention of venous thromboembolism after elective total hip replacement surgery.
DRI4757 III A multicenter, randomized, double-blind, placebo-controlled, parallel group, dose response study of subcutaneous Org31540/SR90107A in the prevention of venous thromboembolism after elective total knee replacement surgery.
EFC2441 III A multicentre, randomized, double-blind study comparing the efficacy and safety of once daily (o.d.) Org31540/SR90107A versus twice daily (b.i.d.) enoxaparin in the initial treatment of acute symptomatic deep vein thrombosis (DVT) (MATISSE-DVT)
EFC2442 III A multicenter, multinational, randomized, double-blind comparison of subcutaneous Org31540/SR90107A with enoxaparin in the prevention of deep vein thrombosis and symptomatic pulmonary embolism after elective hip replacement or a revision. PENTATHLON 2000
EFC2698 III A multicenter, multinational, randomized double-blind comparison study of subcutaneous Org31540/SR90107A versus enoxaparin 40 mg o.d. in the prevention of deep vein thrombosis and symptomatic pulmonary embolism in hip fracture surgery. (PENTHIFRA)
EFC3557 III A multicenter, multinational, randomized, double-blind study to compare the efficacy and safety of fondaparinux sodium (Org31540/SR90107A) with dalteparin (Fragmin) in the prevention of venous thromboembolic events in high-risk abdominal surgery (PEGASUS)
EFC4582 III A multicenter, multinational, randomized, double-blind study of fondaparinux sodium (Org31540/SR90107A) versus placebo for the prolonged prevention of VTE in hip fracture surgery. (PENTIHFRA PLUS)
L8405 III A multi-centre, randomised, open-label, parallel group, comparative study of the efficacy and safety of once daily fondaparinux 2.5mg versus fondaparinux 2.5mg plus graduated compression stockings for the prevention of venous thromboembolism in patients undergoing elective or emergency hip surgery
L-8541 III Arixtra VTE Prevention Study - Fondaparinux compared with enoxaparin in the prevention of venous thromboembolism (VTE) in Chinese patients undergoing elective knee replacement, hip surgery or a revision of components.
L-8635 III Fondaparinux compared with enoxaparin in the prevention of venous thromboembolism in Taiwanese patients undergoing elective knee replacement.
63113 II A randomized, assessor-blind, dose reducing, phase II study to assess the safety and efficacy of 10, 8, 6 and 4 mg Org31540/SR90107A and standard treatment with intravenous fragmin in patients with chronic intermittent haemodialysis
*095001 II A multicenter, concurrent control, randomized, open-label, assessor-blind, dose-ranging study of Org 31540/SR90107A in the prophylaxis of deep vein thrombosis in subjects undergoing total knee replacement surgery (PENTATAK).
ACT1840 II A multicentre pilot study of natural pentasaccharide (SR90107A /Org31540) for the prevention of deep venous thrombosis after total hip replacement.
ACT2445 II Pilot efficacy study of a single I.V. injection of Pentasaccharide (SR90107A/ORG 31540) in patients undergoing coronary angioplasty
ACT2545 II A multicentre dose finding study of once daily injection of Natural Pentasaccharide for the prevention of deep vein thrombosis after total hip replacement.
AR1104574 (63133 – ASPIRE) II A randomized blinded pilot trial of fondaparinux sodium (Arixtra®) versus unfractionated heparin in addition to standard therapy in a broad range of patients undergoing percutaneous coronary intervention (ASPIRE)
Arixtra 63119 II A double blind, randomized, controlled, dose ranging study of Org31540/SR90107A in patients with unstable angina pectoris: PENTUA
DRI2440 – Rembrandt II A Multicentre, Randomized, Double-Blind, Dose Ranging Study of Org31540/SR90107A in the Initial Treatment of Symptomatic Proximal Deep Vein Thrombosis (DVT)
DRI2643 II A multicenter, randomized, parallel, double-blind, dose ranging study of subcutaneous Org31540/SR90107A with an assessor blind, comparative control group of subcutaneous LMWH in the prevention of deep vein thrombosis after elective total hip replacement. Pentathlon
DRI3196 II A multicentre, randomised, dose-ranging study comparing Org31540/SR90107A with heparin as adjunctive therapy to recombinant tissue plasminogen activator and Aspirin in acute myocardial infarction (AMI) (PENTALYSE
INT 3012 II Influence of Forced Diuresis on the Pharmacokinetics of Org31540/SR90107 After a Single Dose of 10 mg s.c. of Org31540/SR90107A in Healthy Male Subjects
63102 I A single, rising dose study of the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous Org31540/SR90107A in healthy male and female elderly volunteers
63103 I A repeated rising-dose, placebo-controlled study of the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous Org31540/SR90107A administered for 7 consecutive days to healthy male and female elderly volunteers
63105 I A study to evaluate safety, tolerability and pharmacokinetics of 2, 4, 6, 12, 16,18, and 20 mg of the pentasaccharide Org31540/SR90107A, administered as a single intravenous bolus injection to healthy elderly subjects
63106 I A four-period cross-over study to assess the absolute bioavailability, safety and tolerability of the pentasaccharide Org31540/SR90107A, after single dose subcutaneous administration of 2, 4 and 8 mg compared with 4 mg intravenous administration to healthy elderly subjects
63107 I Study to Assess the Safety/Tolerability and the Pharmacokinetics/Pharmacodynamics of Org31540/SR90107A Administered As A Single Intravenous Bolus Injection to Healthy Volunteers and Patients with Impaired Renal Function
63108 I An interaction study with subcutaneously administered Org31540/SR90107A and oral warfarin in healthy male volunteers (Protocol 63108)
63128 I A phase I interaction trial to investigate the pharmacodynamics and pharmacokinetics of 10 mg subcutaneous Org31540/SR90107A and intravenous recombinant Factor VIIa, in healthy male volunteers.
63132 I A phase I trial to evaluate and compare the safety, pharmacokinetics and pharmacodynamics of a single dose of 7.5mg subcutaneous Org31540/SR90107A in subjects with moderate hepatic impairment and subjects with normal liver function
63109_B I Interaction study with Org31540/SR90107A and piroxicam in healthy male volunteers
BDR3780 I A single dose bioequivalence study comparing a new formulation of Org31540/SR90107A and the reference formulation in healthy male subjects
BDR4979 I A single dose bioequivalence study comparing a new formulation of fondaparinux sodium at 12.5 mg/mL and the reference formulation at 10 mg/mL, in healthy male subjects. Open, randomized, crossover and single center study
INT 2767 I Interaction Study of 975mg Aspirin Given at Steady State of 10mg/sc SR90107A/Org31540 in Healthy Male Subjects
INT3933 I Assessment of pharmacokinetic and pharmacodynamic drug interactions between ORG31540/SR90107A and digoxin in healthy male subjects
P1653 I A single rising dose study of the safety, tolerability, pharmacokinetics & pharmacodynamics of subcutaneous SR90107A/ORG31540 natural pentasaccaride in healthy male volunteers
PKM5053 I A repeated dose study to assess the pharmacokinetic profiles and the safety of Org31540/SR90107A by subcutaneous administration of 0.75, 1.5, 2.5, and 3.0mg to Japanese healthy elderly subjects
POP5108 I A repeated dose pharmacokinetic study in healthy volunteers to compare 1.5 mg of fondaparinux sodium in subjects with a low (35 to 50 kg) body weight (LBW) to 2.5 mg of fondaparinux sodium in subjects with standard (60 to 100 kg) body weight (SBW)
TDR3088 I Safety, pharmacokinetics and pharmacodynamics (PD) of Org31540/SR90107A after repeated intravenous injection in healthy male volunteers
TDU3085 I Safety and pharmacokinetics of ORG31540/SR90107A after a single intravenous injection in healthy male volunteers
TDU3166 I A study to investigate the safety, pharmacokinetics and pharmacodynamics (PD) of ORG31540/SR90107A administered as a single intravenous drip to healthy male volunteers
TDU4089 I A safety, pharmacokinetics and bioavailability study after single dose subcutaneous administration of Org31540/SR90107A 0.75, 2.5, and 8mg in young adult Japanese healthy male subjects.
TDU4289 I A safety and pharmacokinetics study after single dose subcutaneous administration of Org31540/SR90107A 2.5mg in elderly Japanese healthy male volunteers.