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Study ID Status Title Patient Level Data
63106 Completed 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 Completed 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 Completed An interaction study with subcutaneously administered Org31540/SR90107A and oral warfarin in healthy male volunteers (Protocol 63108)
63109_B Completed Interaction study with Org31540/SR90107A and piroxicam in healthy male volunteers
63113 Completed 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
63118 Completed 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 ...
63119 Completed A double blind, randomized, controlled, dose ranging study of Org31540/SR90107A in patients with unstable angina pectoris: PENTUA
63123 Completed 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)
63128 Completed 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 Completed 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
675187/001 Completed A Phase II, open, randomized, controlled study to evaluate the reactogenicity and safety of an investigational vaccination regimen in healthy toddlers aged 24-30 months. Study Listed on ClinicalStudyDataRequest.com
683699/003 Completed A Randomised, Double-blind, Placebo-controlled, Parallel Group, dose ranging study to investigate the efficacy and safety of three months administration of SB-683699 (150 - 1200mg twice daily) in subjects with relapsing multiple sclerosis
684289/001 Completed A phase IV, open, randomised study in adults aged 18-60 and over 60 years to evaluate the immunogenicity and the reactogenicity of GlaxoSmithKline Biologicals' Fluarix™ vaccine administered using two different routes Study Listed on ClinicalStudyDataRequest.com
701464/005 Completed A phase III, open, controlled, randomised study in adults aged 18-60 and elderly aged over 60 years to confirm the immunogenicity and the reactogenicity of GlaxoSmithKline Biologicals' investigational influenza vaccine Study Listed on ClinicalStudyDataRequest.com
710158/002 Completed A primary vaccination study to evaluate immunogenicity, safety and reactogenicity of 3 doses of GSK Biologicals/Finlay’s meningococcal B candidate vaccine given intramuscularly using either 0-2-4 month or 0-1-6 month schedule to healthy subjects aged 12-18 years Study Listed on ClinicalStudyDataRequest.com
711202/001 Completed Evaluate immunogenicity, reactogenicity, safety of GSK Biologicals’ MenC-TT vaccine (2 formulations) given with Infanrix hexa® + GSK Biologicals’ Hib MenC-TT vaccine (2 formulations) given with Infanrix penta® to infants in mths 3,4,5 of life Study Listed on ClinicalStudyDataRequest.com
711202/008 Completed Evaluate the persistence and immune memory induced by a primary vaccination course with GSK Biologicals’ MenC-TT (1 formulation) & GSK Biologicals’ Hib-MenC-TT (2 formulations) or Meningitec™ in healthy toddlers aged 12-15 months primed in study 711202/001 Study Listed on ClinicalStudyDataRequest.com
711866/001 Completed A study to assess the lot-to-lot consistency of GSK Biologicals dTpa-IPV vaccine administered to healthy children 4 to 8 years of age, previously vaccinated with four doses of DTPa or DTPa-based combination vaccines and at least 3 doses of OPV or IPV Study Listed on ClinicalStudyDataRequest.com
711866/002 Completed Open, randomised, multicenter, Phase II clinical trial to assess the immunogenicity and reactogenicity of GlaxoSmithKline (GSK) Biologicals' dTpa-IPV vaccine compared to GSK Biologicals' dTpa (Boostrix™) and Aventis Pasteur Merck Sharp Dohme’s (MSD) IPV (Imovax Polio®) vaccines administered separately, and to assess immunogenicity and reactogenicity of GSK Biologicals' DTPa-IPV vaccine (Infanrix-IPV™), when administered to healthy adolescents aged 10-14 years. Study Listed on ClinicalStudyDataRequest.com
711866/003 Completed Assess immunogenicity, reactogenicity of GSK Biologicals’-dTpa-IPV vaccine versus dTpa & IPV vaccines administered separately & compared with Aventis Pasteur MSD’s Td-IPV vaccine when administered to healthy adolescents & adults Study Listed on ClinicalStudyDataRequest.com
711866/005 Completed Open, 1-year, phase III, immunogenicity follow-up of subjects who previously received GSK Biologicals’ dTpa-IPV vaccine or GSK Biologicals’ dTpa (BoostrixTM) and Pasteur Mérieux’s IPV vaccine (IPV Mérieux() administered separately, at 4 to 8 years of age in study 711866/001 (dTpa-IPV-001)
711866/006 Completed A phase III, open study to evaluate the immunogenicity, safety and reactogenicity of GSK Bios’ dTpa-IPV vaccine when administered as a booster vaccination to healthy children (6-8 Y) and previously vaccinated with 4 doses of DTPw and at least 3 doses of OPV/ IPV vaccines
712753/001 Completed A Bioequivalence Study with a Combination Tablet Formulation of Rosiglitazone and Metformin (4mg/1000mg) Compared to the Commercial Tablet Formulation of AVANDAMET (2mg rosiglitazone/500mg metformin) and a Dose Proportionality Study Comparing the Combination Tablet Formulations of Rosiglitazone and Metformin (4mg/1000mg & 2mg/1000mg). Study Listed on ClinicalStudyDataRequest.com
712753/002 Completed A phase III, 24 week, multi-centre, randomised, double-blind, parallel group, dose escalation study of Avandamet (rosiglitazone/metformin) and high dose metformin monotherapy in subjects with poorly controlled type 2 diabetes mellitus Study Listed on ClinicalStudyDataRequest.com
712753/003 Completed A Phase III Multi-Centre, Double-Blind, Randomised, Parallel-Group, Dose Escalation Study Comparing the Effects of 32 Weeks Administration of Avandamet and Metformin on Hba1c Targets in Subjects With Mild Type 2 Diabetes Mellitus Study Listed on ClinicalStudyDataRequest.com

 

 

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GSK-sponsored clinical studies are those for which GSK is ultimately responsible for all aspects of the study even if some or all of these activities are transferred to another party.
GSK-sponsored clinical trials are those for which GSK is ultimately responsible for all aspects of the study even if some or all of these activities are transferred to another party.

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