Result Summaries: fondaparinux

Result Summaries for fondaparinux
GSK
Study ID
Phase Title Summary (Download)
63102 Phase 1 A single, rising dose study of the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous Org31540/SR90107A in healthy male and female elderly volunteers (0 citation(s)) Click here to download result summary.
63103 Phase 1 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 (4 citation(s)) Click here to download result summary.
63105 Phase 1 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 (2 citation(s)) Click here to download result summary.
63106 Phase 1 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 (1 citation(s)) Click here to download result summary.
63107 Phase 1 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 (2 citation(s)) Click here to download result summary.
63108 Phase 1 An interaction study with subcutaneously administered Org31540/SR90107A and oral warfarin in healthy male volunteers (Protocol 63108) (3 citation(s)) Click here to download result summary.
63113 Phase 2 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 (0 citation(s)) Click here to download result summary.
63118 Phase 3 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 replacem ... (8 citation(s)) Click here to download result summary.
63119 Phase 2 A double blind, randomized, controlled, dose ranging study of Org31540/SR90107A in patients with unstable angina pectoris: PENTUA (1 citation(s)) Click here to download result summary.
63123 Phase 3 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) (18 citation(s)) Click here to download result summary.
63128 Phase 1 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. (1 citation(s)) Click here to download result summary.
63132 Phase 1 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 (0 citation(s)) Click here to download result summary.
95001 Phase 2 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). (1 citation(s)) Click here to download result summary.
DRI2440 – Rembrandt Phase 2 A Multicentre, Randomized, Double-Blind, Dose Ranging Study of Org31540/SR90107A in the Initial Treatment of Symptomatic Proximal Deep Vein Thrombosis (DVT) (1 citation(s)) Click here to download result summary.

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