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Study ID Status Title Patient Level Data
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
712753/004 Completed An open-label trial to evaluate the safety and efficacy of fixed dose rosiglitazone/metformin combination therapy in poorly-controlled subjects with type 2 diabetes mellitus Study Listed on ClinicalStudyDataRequest.com
712753/007 Completed A randomized, double-blind trial to evaluate the efficacy and safety of fixed dose rosiglitazone/metformin combination therapy compared to both rosiglitazone and metformin monotherapies in drug naive type 2 diabetes mellitus subjects Study Listed on ClinicalStudyDataRequest.com
712753/008 Completed AVANDAMET Compared to Metformin Evaluation Trial (ACME): A 48-week Randomized, Open-label, multicenter study to compare the efficacy and tolerability of AVANDAMET to metformin monotherapy in subjects with Type 2 Diabetes Mellitus who are not achieving glycemic control on submaximal metformin.
712753/009 Completed A 24 week, randomised, double blind, parallel study to compare the change in HbA1c with AVANDAMET® (8.0mg / 2.0g) plus insulin to placebo plus insulin, in subjects with type 2 diabetes starting insulin therapy Study Listed on ClinicalStudyDataRequest.com
712753/011 Completed A study to assess the effect of food and time of dosing on the pharmacokinetics of Avandamet™ (rosiglitazone maleate 8 mg/metformin HCl 1000 mg administered as 2 × 4/500) Glucophage XR 1000 mg (given as metformin HCl 2 × 500 mg) and Avandia™ (rosiglitazone maleate 8 mg) in healthy adult subjects. Study Listed on ClinicalStudyDataRequest.com
712753/012 Completed A study to estimate the pharmacokinetics of six extended release formulations of AVANDAMET (rosiglitazone maleate 4mg / metformin HCl 1000mg), compared to the commercial formulation of AVANDAMET (rosiglitazone maleate 2mg / metformin HCl 500mg, q12h), and concomitant dosing of Glucophage XR (metformin HCl 2 × 500mg) with AVANDIA (rosiglitazone maleate 4mg) Study Listed on ClinicalStudyDataRequest.com
712753/014 Completed A study to assess the steady state pharmacokinetics of repeat oral doses of AVANDAMET XR (combination formulation of rosiglitazone 8mg/metformin 1000mg) and AVANDAMET IR (rosiglitazone 4mg/metformin 500mg) in healthy subjects Study Listed on ClinicalStudyDataRequest.com
719125/002 Completed A multicenter Phase I open-label dose-escalation vaccine trial of dHER2 protein with AS15 adjuvant in HER2-overexpressing patients with high-risk breast cancer

 

 

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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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