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fondaparinux sodium
Result Summaries: fondaparinux sodium
Result Summaries for fondaparinux sodium
GSK
Study ID
Phase
Title
Summary (Download)
095-002
Phase 3
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). (1 citation(s))
103413
Phase 3
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. (1 citation(s))
103414
Phase 3
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 ... (0 citation(s))
103420
Phase 3
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 (2 citation(s))
104326
Phase 4
ARISTOTE Study: French cohort Study conducted to determine how ARIXTRA® 2.5 mg is used in every day practice, and to document the incidence of Venous Thromboembolic Events (VTEs) and major bleeding after orthopaedic surgery (0 citation(s))
104574
Phase 2
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) (1 citation(s))
104619
Phase 3
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). (9 citation(s))
106206
phase 3
Clinical Evaluation of GSK576428 (Fondaparinux Sodium) in the Treatment of Acute Pulmonary Thromboembolism (PE) (0 citation(s))
108034
Phase 4
A post marketing survailance to monitor the safety of Arixtra administered in Korean subjects according to the prescription information (0 citation(s))
110147
Phase 4
ARIANE study: Arixtra and Platelet Monitoring (0 citation(s))
111271
Phase 4
Arixtra observational study; A multi-centre, prospective observational study to evaluate the incidence of venous thromboembolism(VTE) in Korean patients with Arixtra™ therapy in real world setting (0 citation(s))
111436
phase 3
Clinical Evaluation of GSK576428 (Fondaparinux Sodium) in the Treatment of Acute Deep Vein Thrombosis (DVT) (0 citation(s))
63109_B
Phase 1
Interaction study with Org31540/SR90107A and piroxicam in healthy male volunteers (4 citation(s))
ACT1840
Phase 2
A multicentre pilot study of natural pentasaccharide (SR90107A /Org31540) for the prevention of deep venous thrombosis after total hip replacement. (0 citation(s))
ACT2445
Phase 2
Pilot efficacy study of a single I.V. injection of Pentasaccharide (SR90107A/ORG 31540) in patients undergoing coronary angioplasty (2 citation(s))
ACT2545
Phase 2
A multicentre dose finding study of once daily injection of Natural Pentasaccharide for the prevention of deep vein thrombosis after total hip replacement. (1 citation(s))
AR3106116
Phase 3
Clinical Evaluation of GSK576428 (Fondaparinux Sodium) in Prevention of Venous Thromboembolism (VTE) after Abdominal Surgery (0 citation(s))
AR3106333
Phase 3
Clinical Evaluation of GSK576428 (Fondaparinux Sodium) in Prevention of Venous Thromboembolism after Elective Total Hip Replacement Surgery (0 citation(s))
AR3106335
Phase 3
Clinical Evaluation of GSK576428 (Fondaparinux Sodium) in Prevention of Venous Thromboembolism after Hip Fracture Surgery (0 citation(s))
ART108053
phase 3
See Detailed Description (0 citation(s))
BDR3780
Phase 1
A single dose bioequivalence study comparing a new formulation of Org31540/SR90107A and the reference formulation in healthy male subjects (4 citation(s))
BDR4979
Phase 1
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 (0 citation(s))
C8843
Phase 3
Multinational/multicentre, non-randomized, open label study to assess efficacy and safety of fondaparinux sodium (ARIXTRA.) use in daily practice in subjects undergoing major orthopedic surgery of the lower limbs (0 citation(s))
DRI2643
Phase 2
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). (1 citation(s))
DRI3196
Phase 2
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) (2 citation(s))
DRI4090
Phase 3
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. (0 citation(s))
DRI4757
Phase 3
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. (0 citation(s))
EFC2441
Phase 3
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) (9 citation(s))
EFC2442
Phase 3
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 (1 citation(s))
EFC2698
Phase 3
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) (6 citation(s))
EFC3557
Phase 3
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) (6 citation(s))
EFC4582
Phase 3
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) (21 citation(s))
INT 2767
Phase 1
Interaction Study of 975mg Aspirin Given at Steady State of 10mg/sc SR90107A/Org31540 in Healthy Male Subjects (3 citation(s))
INT 3012
Phase 2
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 (1 citation(s))
INT3933
Phase 1
Assessment of pharmacokinetic and pharmacodynamic drug interactions between ORG31540/SR90107A and digoxin in healthy male subjects (3 citation(s))
L_8598
Phase 4
Fondaparinux sodium in ORthopaedic SurgEry (FORSE): A Prospective Evaluation of ArixtraTM for the Prevention of Symptomatic Venous Thromboembolism in Orthopaedic Surgery (0 citation(s))
L8405
Phase 3
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 (0 citation(s))
L8518
Phase 4
Flexibility in administration of Arixtra for prevention of symptomatic venous thromboembolism in orthopedic surgery (4 citation(s))
L-8541
Phase 3
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. (0 citation(s))
L-8635
Phase 3
Fondaparinux compared with enoxaparin in the prevention of venous thromboembolism in Taiwanese patients undergoing elective knee replacement. (0 citation(s))
P1653
Phase 1
A single rising dose study of the safety, tolerability, pharmacokinetics & pharmacodynamics of subcutaneous SR90107A/ORG31540 natural pentasaccaride in healthy male volunteers (1 citation(s))
PKM5053
Phase 1
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 (0 citation(s))
POP5108
Phase 1
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) (0 citation(s))
TDR3088
Phase 1
Safety, pharmacokinetics and pharmacodynamics (PD) of Org31540/SR90107A after repeated intravenous injection in healthy male volunteers (0 citation(s))
TDU3085
Phase 1
Safety and pharmacokinetics of ORG31540/SR90107A after a single intravenous injection in healthy male volunteers (0 citation(s))
TDU3166
Phase 1
A study to investigate the safety, pharmacokinetics and pharmacodynamics (PD) of ORG31540/SR90107A administered as a single intravenous drip to healthy male volunteers (0 citation(s))
TDU4089
Phase 1
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. (0 citation(s))
TDU4289
Phase 1
A safety and pharmacokinetics study after single dose subcutaneous administration of Org31540/SR90107A 2.5mg in elderly Japanese healthy male volunteers. (0 citation(s))
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