Zoekresultaten - Portaal voor medische datamodellen (MDM-portaal)

Study End/ Follow Up GSK Rosiglitazone Alzheimer's disease 100468

- 25.07.17 - 1 Formulier, 9 Itemgroepen, 14 Data-elementen, 1 Taal

Itemgroepen: Central Laboratory Instructions, Visit Information, Investigator Instructions, Vital Signs, Central Laboratory, Concomitant Medication, Adverse Event, Physical Examination, Pedal Oedema

Study ID: 100468 Clinical Study ID: AVA100468 Study Title: An open-label extension to study AVA100193, to assess the long-term safety and efficacy of rosiglitazone (extended release tablets) in subjects with mild to moderate Alzheimer's disease Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Avandia XR,Rosiglitazone XR,Avandia Study Indication: Alzheimer's Disease Study End/ Follow Up

M.Alzheimer GSK - Study End/Follow-up NCT00334568/ GSK-AVA100193 - NCT00334568/ GSK-AVA100193: M.Alzheimer GSK - Study End/Follow-up

- 05.12.16 - 1 Formulier, 8 Itemgroepen, 15 Data-elementen, 1 Taal

Itemgroepen: General Information, Instructions, Vital signs, Central Laboratory (Non Fasting Samples), Concomitant Medications, Adverse Events, Physical Examination, Pedal Oedema

NCT00334568/ GSK-AVA100193: M.Alzheimer GSK A 24 week double-blind, randomized, placebo-controlled, parallel-group dose-raging study to investigate the effects of rosiglitazone (extended release tablets) on cognition in subjects with mild to moderate Alzheimer´s disease. Medicine: rosiglitazone, Condition: Alzheimer´s Disease, Phase: 2, Clinical Study ID: AVA 100193, Sponsor: GSK. This ODM contains the Study End/Follow-up

Radium-223 Dichloride (Alpharadin) DRKS00006460 NCT01618370 in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases (Survival Follow-up) - Radium 223 Dichloride (Alpharadin) - Survival Follow-up

- 30.03.17 - 1 Formulier, 2 Itemgroepen, 7 Data-elementen, 1 Taal

Itemgroepen: Survival Assessment, End of Survival Follow-up

This study is a prospective, interventional, open-label, multi-center early access program for the use of Ra-223 Cl2 in HRPC/CRPC (Hormone refractory prostate cancer / Castrate resistant prostate cancer) patients diagnosed with bone metastasis and to collect additional short and long term safety data on the product. NCT01618370

Efficacy and Safety of Single Dose Intranasal GSK1004723 in an Allergen Challenge Chamber NCT00824356 - Follow-Up - Pregnancy Information; Status of Treatment Blind, Study Conclusion

- 02.03.21 - 1 Formulier, 3 Itemgroepen, 9 Data-elementen, 1 Taal

Itemgroepen: Pregnancy Information, Status of Treatment Blind, Study Conclusion

Study ID: 110159 Clinical Study ID: 110159 Study Title: A Randomised, Double-Blind, Placebo-Controlled, 3-Period Crossover Study to Assess the Efficacy and Safety of Single Dose Intranasal GSK1004723 Compared With Placebo in an Allergen Challenge Chamber in Male Subjects With Seasonal Allergic Rhinitis Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00824356 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Placebo, GSK1004723 (200mg), GSK1004723 (1000mg) Study Indication: Allergic Rhinitis

Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673 - Follow-Up - ECG; Vital Signs; Pulmonary Function Test; Pregnancy Information; Status of treatment blind; Study conclusion

- 05.12.20 - 1 Formulier, 9 Itemgroepen, 36 Data-elementen, 1 Taal

Itemgroepen: Date of visit/assessment, ECG, Vital Signs - Follow-up 1, Vital Signs - Follow-up 2, Vital Signs - Follow-up 3, Pulmonary Function Tests, Pregnancy Information, Status of Treatment Blind, Study Conclusion

Study ID: 110106 Clinical Study ID: 110106 Study Title: A single centre, randomized, double-blind, dose ascending, placebo-controlled study, in two parts, to evaluate the safety, tolerability and pharmacokinetics of escalating single and repeat inhaled doses of GSK573719 and placebo formulated with the excipient magnesium stearate, in healthy subjects and in a healthy population of Cytochrome P450 Isoenzyme 2D6 poor metabolisers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00803673 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK573719, Placebo Study Indication: Pulmonary Disease, Chronic Obstructive

Effects of Esomeprazole on Lapatinib in Subjects with Breast Cancer; 109275 - Follow-up

- 25.06.20 - 1 Formulier, 10 Itemgroepen, 187 Data-elementen, 1 Taal

Itemgroepen: Date of visit, Vital signs, 12 lead ECG, 12 lead ECG, Abnormality, Experimental drug, Continuation status, Laboratory Procedures, Chemistry, Clinical, Laboratory Procedures, Hematology finding, Conclusion, Clinical Research, Cessation of life, Pregnancy, Information

Study ID: 109275 Clinical Study ID: 109275 Study Title: An Open-Label, Single Sequence Study to Examine the Effects of Esomeprazole on the Pharmacokinetics of Orally Administered Lapatinib in Subjects with Metastatic ErbB2 Positive Breast Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Lapatinib, Esomeprazole Trade Name: lapatinib plus esomeprazole Study Indication: Neoplasms, Breast

Effect of GSK958108 on ejaculatory latency time (ELT); NCT00861484 - Follow-up

- 06.06.20 - 1 Formulier, 14 Itemgroepen, 167 Data-elementen, 1 Taal

Itemgroepen: Date of visit, Vital signs, 12 lead ECG, Laboratory Procedures, Hematology finding, Laboratory Procedures, Chemistry, Clinical, Laboratory Procedures, Urinalysis, Laboratory Procedures, Hormones, Laboratory Procedures, Free Testosterone Measurement, Laboratory Procedures, Prolactin measurement, Nervous system structure, Evaluation, Ophthalmic examination and evaluation, Blinded Clinical Study, Status, Pregnancy, Information, Conclusion, Clinical Research

Study ID: 111155 Clinical Study ID: 111155 Study Title: A double blind, parallel group, placebo controlled study to evaluate the effect of a single oral dose of GSK958108 on ejaculatory latency time (ELT) in male patients suffering from premature ejaculation. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00861484 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK958108 , Placebo Trade Name: N/A Study Indication: Premature Ejaculation

Effect of ropinirole on cardiac conduction as assessed by 12-lead electrocardiogram (101468/902) - Follow-Up - Pregnancy Information; Study Conclusion; Investigator's Statement; General Comments

- 29.05.20 - 1 Formulier, 5 Itemgroepen, 18 Data-elementen, 1 Taal

Itemgroepen: Administrative, Pregnancy Information, Study Conclusion, Investigator's Statement, General Comments

Study ID: 101468/902 Clinical Study ID: 101468/902 Study Title:A study to evaluate the effect of repeated oral doses of ropinirole on cardiac conduction as assessed by 12-lead electrocardiogram compared to placebo and single oral doses of moxifloxacin (Bayer) as a positive control. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome

GSK Study ID 100386 & 100387 Persistence of immune response to TWINRIX™ ADULT Additional Vaccination Year 6- Long Term Follow up and Study conclusion - Additional Vaccination Year 6- Long Term Follow up and Study conclusion

- 23.10.17 - 1 Formulier, 10 Itemgroepen, 50 Data-elementen, 1 Taal

Itemgroepen: Additional Vaccination Visit 10, Study Continuation, Laboratory Tests, Concomitant Vaccination, Concomitant Vaccination, Concomitant Medications, Concomitant Medications, Non-Serious Adverse Events, Non-Serious Adverse Events, Study Conclusion

Phase III, open, randomized study, in two centres, to demonstrate the equivalence of the 0, 12 month schedule to the 0, 6 month schedule with respect to the immunogenicity and to evaluate the safety and reactogenicity of GlaxoSmithKline Biologicals’ combined hepatitis A/ hepatitis B vaccine TWINRIX™ ADULT (720 EL. U. of hepatitis A antigen/ 20 μg of recombinant hepatitis B surface antigen) in healthy volunteers aged from 12 to 15 years inclusive. NCT00197171

Immunogenicity of malaria vaccine candidate - NCT00323622 / Malaria-039 - Reason for Non Participation - Tracking Form

- 06.06.19 - 1 Formulier, 3 Itemgroepen, 10 Data-elementen, 1 Taal

Itemgroepen: Administrative data, Reason for non participation, Investigator's Signature

Study ID: 104297 Clinical Study ID: 104297 Study Title: An open study for a 2-year period to confirm the safety and immunogenicity of the candidate malaria vaccine RTS,S/AS02A in Mozambican children aged 1 to 4 years at the time of first vaccine dose. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00323622 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB257049 Trade Name: SB257049 Study Indication: Malaria This study (Malaria-039 / NCT00323622 / GlaxoSmithKline Study ID 104297) is a two-year follow-up to Malaria-026 and consists of three clinic visits: Visit 1 / Informed Consent Visit at Visit 7 of Malaria-026 (i.e. 21 months post vaccine dose 1 in Malaria-026). Visit 2 / Interim Analysis 12 months +/- 1 month after Visit 1. Visit 3 / Final Analysis 24 months +/- 1 month after Visit 1. See https://clinicaltrials.gov/ct2/show/NCT00323622 This document is to be completed at Visit 1 / Informed Consent Visit in case of non-participation.

Safety, reactogenicity and immunogenicity 10-valent pneumococcal conjugate vaccine compared to Prevenar™, co-administration of DTPw-HBV/Hib and OPV or IPV vaccines in infants, NCT00344318 - Follow-up studies, Study conclusion, Investigator's signature

- 15.04.19 - 1 Formulier, 4 Itemgroepen, 25 Data-elementen, 1 Taal

Itemgroepen: Administrative data, Follow-up studies, Study conclusion, Investigator's Signature

Study ID: 107007 Clinical Study ID: 107007 Study Title: A phase IIIb randomized, double-blind, controlled study to assess the safety, reactogenicity and immunogenicity of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine compared to Prevenar™, when co-administered with DTPw-HBV/Hib and OPV or IPV vaccines as a 3-dose primary immunization course during the first 6 months of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00344318 https://clinicaltrials.gov/ct2/show/NCT00344318 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Pneumococcal conjugate vaccine GSK1024850A Trade Name: Prevenar, Tritanrix-HepB, Hiberix, Polio Sabin., Poliorix Study Indication: Infections, Streptococcal This study consists of 2 groups of probands (Children of 6-10-14 weeks or 2-4-6 months of age are included): One group receive a 3-dose primary vaccination with the GSK Biologicals' (10-valent) pneumococcal conjugate vaccine. The other group r eceive a 3-dose primary vaccination with Prevenar™. All probands receive DTPw-HBV/Hib and OPV or IPV vaccines. Ths study consists of 3 workbooks (WB): WB 1: The WB 1 consists 4 visits (all in active phase): Visit 1, Timing: Month 0; Age for 6-12 weeks scheduled Visit 2, Timing: Month 1; Age for 10 weeks scheduled Visit 3, Timing: Month 2; Age for 14 weeks scheduled Visit 4, Timing: Month 3; Age for +/- 4 months scheduled Intervals between the visits: Visit 1 to Visit 2: 28-42 days, Visit 2 to Visit 3: 28-42 days, Visit 3 to Visit 4: 30-42 days WB 2: The WB 2 consists 4 visits (all in active phase): Visit 1, Timing: Month 0; Age for 6-12 weeks scheduled Visit 2, Timing: Month 2; Age for +/- 4 months scheduled Visit 3, Timing: Month 4; Age for +/- 6 months scheduled Visit 4, Timing: Month 5; Age for +/- 7 months scheduled Intervals between the visits: Visit 1 to Visit 2: 49-83 days, Visit 2 to Visit 3: 49-83 days, Visit 3 to Visit 4: 30-42 days WB 3: The WB 3 consists the phone contact (6 months safety follow-up), Timing: Month 8 or 10. This document contains the Follow-up studies, Study conclusion and Investigator's signature form. It has to be filled in for the end of study.

Cisplatin and Topotecan Recurrent or Persistent Carcinoma of the Cervix - 103369 - Treatment Completion Form

- 14.03.19 - 1 Formulier, 10 Itemgroepen, 39 Data-elementen, 1 Taal

Itemgroepen: Administrative data, Treatment Completion, Tumor Measurements, Best Tumor Response, Follow-Up Form, Disease Follow-Up Status, Notice of New Primary, Long Term Adverse Events, Adverse Events details, Additional Cancer Therapy

Study ID: 103369 Clinical Study ID: 103369 Study Title: A Randomized Phase III Study of Cisplatin Versus Cisplatin plus Topotecan Versus MVAC in Stage IVB, Recurrent or Persistent Squamous Cell Carcinoma of the Cervix Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: Topotecan Study Indication: Cancer

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