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)) Click here to download result summary.
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)) Click here to download result summary.
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)) Click here to download result summary.
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)) Click here to download result summary.
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)) Click here to download result summary.
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)) Click here to download result summary.
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)) Click here to download result summary.
106206 phase 3 Clinical Evaluation of GSK576428 (Fondaparinux Sodium) in the Treatment of Acute Pulmonary Thromboembolism (PE) (0 citation(s)) Click here to download result summary.
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)) Click here to download result summary.
110147 Phase 4 ARIANE study: Arixtra and Platelet Monitoring (0 citation(s)) Click here to download result summary.
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)) Click here to download result summary.
111436 phase 3 Clinical Evaluation of GSK576428 (Fondaparinux Sodium) in the Treatment of Acute Deep Vein Thrombosis (DVT) (0 citation(s)) Click here to download result summary.
63109_B Phase 1 Interaction study with Org31540/SR90107A and piroxicam in healthy male volunteers (4 citation(s)) Click here to download result summary.
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)) Click here to download result summary.
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)) Click here to download result summary.
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)) Click here to download result summary.
AR3106116 Phase 3 Clinical Evaluation of GSK576428 (Fondaparinux Sodium) in Prevention of Venous Thromboembolism (VTE) after Abdominal Surgery (0 citation(s)) Click here to download result summary.
AR3106333 Phase 3 Clinical Evaluation of GSK576428 (Fondaparinux Sodium) in Prevention of Venous Thromboembolism after Elective Total Hip Replacement Surgery (0 citation(s)) Click here to download result summary.
AR3106335 Phase 3 Clinical Evaluation of GSK576428 (Fondaparinux Sodium) in Prevention of Venous Thromboembolism after Hip Fracture Surgery (0 citation(s)) Click here to download result summary.
ART108053 phase 3 See Detailed Description (0 citation(s)) Click here to download result summary.
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)) Click here to download result summary.
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)) Click here to download result summary.
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)) Click here to download result summary.
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)) Click here to download result summary.
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)) Click here to download result summary.
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)) Click here to download result summary.
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)) Click here to download result summary.
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)) Click here to download result summary.
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)) Click here to download result summary.
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)) Click here to download result summary.
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)) Click here to download result summary.
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)) Click here to download result summary.
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)) Click here to download result summary.
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)) Click here to download result summary.
INT3933 Phase 1 Assessment of pharmacokinetic and pharmacodynamic drug interactions between ORG31540/SR90107A and digoxin in healthy male subjects (3 citation(s)) Click here to download result summary.
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)) Click here to download result summary.
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)) Click here to download result summary.
L8518 Phase 4 Flexibility in administration of Arixtra for prevention of symptomatic venous thromboembolism in orthopedic surgery (4 citation(s)) Click here to download result summary.
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)) Click here to download result summary.
L-8635 Phase 3 Fondaparinux compared with enoxaparin in the prevention of venous thromboembolism in Taiwanese patients undergoing elective knee replacement. (0 citation(s)) Click here to download result summary.
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)) Click here to download result summary.
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)) Click here to download result summary.
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)) Click here to download result summary.
TDR3088 Phase 1 Safety, pharmacokinetics and pharmacodynamics (PD) of Org31540/SR90107A after repeated intravenous injection in healthy male volunteers (0 citation(s)) Click here to download result summary.
TDU3085 Phase 1 Safety and pharmacokinetics of ORG31540/SR90107A after a single intravenous injection in healthy male volunteers (0 citation(s)) Click here to download result summary.
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)) Click here to download result summary.
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)) Click here to download result summary.
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)) Click here to download result summary.

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