Suchergebnisse - Portal für Medizinische Datenmodelle (MDM-Portal)

The effect of intranasal capsaicin challenge model in healthy volunteers - 111611 - Liver Event Form

- 13.03.19 - 1 Formular, 11 Itemgruppen, 108 Datenelemente, 1 Sprache

Itemgruppen: Administrative data, Liver Event, Investigational Product, Pharmacokinetics - Blood, Medical Conditions, Drug Related Liver Disease Conditions, Other Liver Disease Conditions, Other medical conditions, Alcohol Intake, Liver imaging, Liver Biopsy

Study ID: 111611 Clinical Study ID: 111611 Study Title: A randomised, double-blind, placebo-controlled study to assess the effect of oral, single dose SB-705498 in a validated intranasal capsaicin challenge model in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00731250 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB-705498, Placebo, Caspaicin Trade Name: N/A Study Indication: Rhinitis

Candidate Formulations of Pneumococcal Vaccines in Elderly Subjects - 111652 - Lab Reference Ranges, Consent Form

- 07.03.19 - 1 Formular, 6 Itemgruppen, 89 Datenelemente, 1 Sprache

Itemgruppen: Administrative data, LABORATORY REFERENCE RANGES, Hematology, Blood Chemistry, USE OF HUMAN SAMPLES BY GSK, INVESTIGATOR'S SIGNATURE

Study ID: 111652 Clinical Study ID: 111652 Study Title: A Study to Evaluate GSK Biologicals' Candidate Formulations of Pneumococcal Vaccines (GSK2189241A) in Elderly Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00756067 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Pneumococcal vaccine GSK2189241A Trade Name: Pneumo 23™ Study Indication: Infections, Streptococcal

Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032 - Period 1 Day 1 (Visit 80)

- 21.12.18 - 1 Formular, 9 Itemgruppen, 49 Datenelemente, 1 Sprache

Itemgruppen: Administrative data, Admission Criteria, Study Drug Administration, Laboratory Test - Hematology, Laboratory Test - Chemistry, Laboratory Test - UA / UDS / Urine HCG / Urine Chemistry, Vital Signs, Pharmacodynamic Blood Collection, Pharmacodynamic Blood Collection

Study ID: 107032 Clinical Study ID: GLP107032 Study Title: An open-label study to evaluate the pharmacokinetics of an oral contraceptive containing Norethindrone and Ethinyl Estradiol when co-administered with GSK716155 in healthy adult female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01077505 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032 - Run-In Day 21 (Visit 70)

- 21.12.18 - 1 Formular, 5 Itemgruppen, 31 Datenelemente, 1 Sprache

Itemgruppen: Administrative data, Vital Signs, Chemistry / SP Chemistry, Pharmacodynamic Blood Collection, Pharmacodynamic Blood Collection

Study ID: 107032 Clinical Study ID: GLP107032 Study Title: An open-label study to evaluate the pharmacokinetics of an oral contraceptive containing Norethindrone and Ethinyl Estradiol when co-administered with GSK716155 in healthy adult female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01077505 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032 - Visit 50

- 20.12.18 - 1 Formular, 13 Itemgruppen, 49 Datenelemente, 1 Sprache

Itemgruppen: Administrative data, Informed Consent, Admission Criteria, Failed Eligibility Criteria, Demographics, Race, Potentially Childbearing, Electrocardiogram, Overall interpretation of ECG, Hematology Test, Chemistry / Serum HCG / SP Chemistry, UA / UDS / Urine Chemistry, Serology

Study ID: 107032 Clinical Study ID: GLP107032 Study Title: An open-label study to evaluate the pharmacokinetics of an oral contraceptive containing Norethindrone and Ethinyl Estradiol when co-administered with GSK716155 in healthy adult female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01077505 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837 - Liver Events Form

- 07.12.18 - 1 Formular, 2 Itemgruppen, 13 Datenelemente, 1 Sprache

Itemgruppen: Liver Events, Investigational Product (Liver)

Study ID: 106837 Clinical Study ID: HZA106837 Study Title: A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once-Daily in Subjects with Asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01086384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Relvar Study Indication: Asthma

A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837 - Liver Events Assessment Report

- 06.12.18 - 1 Formular, 1 Itemgruppe, 2 Datenelemente, 1 Sprache

Itemgruppe: Liver Events

Study ID: 106837 Clinical Study ID: HZA106837 Study Title: A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once-Daily in Subjects with Asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01086384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Relvar Study Indication: Asthma

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085 - Follow-Up: Liver Chemistry Tests

- 20.11.18 - 1 Formular, 2 Itemgruppen, 12 Datenelemente, 1 Sprache

Itemgruppen: Administrative data, Liver Event Follow-Up Chemistries

Study ID: 107085 Clinical Study ID: GLP107085 Study Title: A Randomized, Double-blind, Parallel, Nested Crossover Study to Investigate the Effect of Albiglutide on Cardiac Repolarization (corrected QT Interval) Compared With Placebo in Healthy Male and Female Subjects: A Thorough ECG Study Employing Placebo, Albiglutide, and a Positive Control (Moxifloxacin) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01406262 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085 - Unscheduled Urine Tests

- 19.11.18 - 1 Formular, 2 Itemgruppen, 16 Datenelemente, 1 Sprache

Itemgruppen: Administrative data, Central Laboratory

Study ID: 107085 Clinical Study ID: GLP107085 Study Title: A Randomized, Double-blind, Parallel, Nested Crossover Study to Investigate the Effect of Albiglutide on Cardiac Repolarization (corrected QT Interval) Compared With Placebo in Healthy Male and Female Subjects: A Thorough ECG Study Employing Placebo, Albiglutide, and a Positive Control (Moxifloxacin) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01406262 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085 - Unscheduled Blood Tests

- 19.11.18 - 1 Formular, 2 Itemgruppen, 16 Datenelemente, 1 Sprache

Itemgruppen: Administrative data, Central Laboratory

Study ID: 107085 Clinical Study ID: GLP107085 Study Title: A Randomized, Double-blind, Parallel, Nested Crossover Study to Investigate the Effect of Albiglutide on Cardiac Repolarization (corrected QT Interval) Compared With Placebo in Healthy Male and Female Subjects: A Thorough ECG Study Employing Placebo, Albiglutide, and a Positive Control (Moxifloxacin) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01406262 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085 - Early Term: Predose Laboratory Tests

- 19.11.18 - 1 Formular, 5 Itemgruppen, 22 Datenelemente, 1 Sprache

Itemgruppen: Administrative data, Timepoint, Hematology, Chemistry/Serum HCG, UA/Urine Chemistry

Study ID: 107085 Clinical Study ID: GLP107085 Study Title: A Randomized, Double-blind, Parallel, Nested Crossover Study to Investigate the Effect of Albiglutide on Cardiac Repolarization (corrected QT Interval) Compared With Placebo in Healthy Male and Female Subjects: A Thorough ECG Study Employing Placebo, Albiglutide, and a Positive Control (Moxifloxacin) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01406262 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085 - Follow-Up: Laboratory Tests

- 16.11.18 - 1 Formular, 5 Itemgruppen, 23 Datenelemente, 1 Sprache