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Study ID Status Title Patient Level Data
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
712753/009 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
759346/001 Completed A phase II, open, randomized, controlled study to evaluate the immunogenicity of investigational vaccinationregimens administered as a three dose primary vaccination course at 6, 10 and 14 weeks of age. Study Listed on ClinicalStudyDataRequest.com
759346/002 Completed Assess immune persistence & memory by giving plain PRP,PSA & PSC (10 mths age), & immunogenicity & safety of a Tritanrix™-HBV/Hib-MenAC/ Tritanrix™-HBV/Hib2.5 booster (15-18 mths age) in previously primed subjects Study Listed on ClinicalStudyDataRequest.com
759346/007 Completed Demonstrate non-inferiority of GSK Biologicals’ Tritanrix™-HepB/Hib-MenAC vs Tritanrix™-HepB/Hiberix™ with respect to anti-HBs immune response, when given to healthy infants at 6,10 & 14 weeks age, after a birth dose of hepatitis B vaccine Study Listed on ClinicalStudyDataRequest.com
759346/009 Completed Study to evaluate immunogenicity, reactogenicity and safety of investigational vaccination regimen as compared to GSK Biological’s Hiberix vaccine, extemporaneously mixed with GSK Biological’s Tritanrix-HepB, when administered intramuscularly in infants at 6, 10 and 14 weeks of age Study Listed on ClinicalStudyDataRequest.com
759348/001 Completed A randomised, controlled phase II study to evaluate the safety and immunogenicity of 7 different formulations of GSK Biologicals’ investigational vaccination regimen, when administered as a 3-dose primary immunisation schedule before 6 months of age, followed by a fourth dose during the second year of life Study Listed on ClinicalStudyDataRequest.com
759348/003 Completed A randomized, controlled, phase II study to evaluate the safety and immunogenicity of four different formulations of GlaxoSmithKline (GSK) Biologicals’ investigational vaccination regimen, when administered as a 3-dose primary immunization schedule beginning before 6 months of age. Study Listed on ClinicalStudyDataRequest.com
763674/001 Completed A phase II, open, randomized, controlled study to evaluate an investigational vaccination regimen administered as athree dose primary vaccination course at 2, 3 and 4 months of age. Study Listed on ClinicalStudyDataRequest.com
763674/002 Completed A phase II open, randomized, controlled study to evaluate an investigational vaccination regimen administered as athree dose primary vaccination course at 2, 3 and 4 months of age. Study Listed on ClinicalStudyDataRequest.com
776423/001 Completed A phase III, observer-blinded randomised, multi-centre clinical study of the safety, immunogenicity and consistency of three manufacturing lots of GSK Biologicals' candidate Tdap vaccine as compared to a US-licensed Td vaccine when given as a booster dose to healthy adolescents (10-18 years of age) Study Listed on ClinicalStudyDataRequest.com
792014/001 Completed A phase II, open (partially double-blind), randomised, controlled, multicentre, primary vaccination study to evaluate the immunogenicity (including immune memory), reactogenicity and safety of three different formulations of the GSK Biologicals’ combined Haemophilus influenzae type b-meningococcal serogroups CY conjugate vaccine given concomitantly with Infanrix® penta and Prevenar®, versus ActHIB® and Meningitec® given concomitantly with Infanrix® penta and versus ActHIB® given concomitantly wi Study Listed on ClinicalStudyDataRequest.com
792014/002 Completed A phase II, open, randomized, controlled, multicentre, primary vaccination study to evaluate the immunogenicity, reactogenicity and safety of an investigational vaccination regimen versus ActHIB® and Menjugate® given concomitantly with Infanrix® penta and Prevenar® in infants Study Listed on ClinicalStudyDataRequest.com
792014/003 Completed A phase II, open (partially double-blind), randomised, controlled, multicentre, primary vaccination study to evaluate the immunogenicity, reactogenicity and safety of three different formulations of GSK Biologicals’ combined Haemophilus influenzae type b-meningococcal serogroups C and Y- conjugate vaccine and one formulation of GSK Biologicals’ Haemophilus influenzae type b-meningococcal serogroup C conjugate vaccine each given concomitantly with InfanrixTM penta, versus MeningitecTM, given conc Study Listed on ClinicalStudyDataRequest.com
797620/001 Completed A dose proportionality study with a combination tablet formulation of rosiglitazone and glimepiride (4mg/1mg; or 4mg/2mg; or 4mg/4mg) in healthy subjects. Study Listed on ClinicalStudyDataRequest.com
797620/002 Completed A bioequivalence study with a combination tablet formulation of rosiglitazone and glimepiride (4mg/4mg) compared to concomitant dosing of rosiglitazone 4mg and glimepiride 4mg (4mg + 4mg) commercial tablets in healthy subjects 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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