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  1. 1. Essai clinique
  2. 2. Routinedokumentation
  3. 3. Études de registres/cohortes
  4. 4. Assurance qualité
  5. 5. Standard de données
  6. 6. Questionnaire pour les patients
  7. 7. Spécialité médicale
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Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032 - Period 1 Day 13 (Visit 110): Pharmacodynamics, Vital Signs, Drug Administration

- 21/12/2018 - 1 Formulaire, 4 Groupes Item, 28 Eléments de données, 1 Langue
Groupes Item: Administrative data, Study Drug Administration, Vital Signs, 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 - Period 1 Day 12 (Visit 100): Vital Signs, Pharmacodynamics, Drug Administration

- 21/12/2018 - 1 Formulaire, 4 Groupes Item, 26 Eléments de données, 1 Langue
Groupes Item: Administrative data, Study Drug Administration, Vital Signs, 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 - Period 1 Day 1 (Visit 80)

- 21/12/2018 - 1 Formulaire, 9 Groupes Item, 49 Eléments de données, 1 Langue
Groupes Item: 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 - Period 1 Day 11 (Visit 90): Vital Signs, Pharmacogenetics, Pharmacodynamics, Drug Admission

- 21/12/2018 - 1 Formulaire, 6 Groupes Item, 36 Eléments de données, 1 Langue
Groupes Item: Administrative data, Admission Criteria, Study Drug Administration, Pharmacogenetic Blood Collection, Vital Signs, 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)

- 21/12/2018 - 1 Formulaire, 5 Groupes Item, 31 Eléments de données, 1 Langue
Groupes Item: 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: Physical Examination

- 20/12/2018 - 1 Formulaire, 6 Groupes Item, 45 Eléments de données, 1 Langue
Groupes Item: Administrative data, Vital Signs, General Physical Examination, General Medical History, Detailed Physical Examination, Assessment
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 Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904 - Session 3: Vital Signs Form

- 13/12/2018 - 1 Formulaire, 23 Groupes Item, 89 Eléments de données, 1 Langue
Groupes Item: Administrative data, Dosing Date and Time, Predose - Semi-supine, Predose Orthostatic - Supine, Predose Orthostatic - Sitting, Predose Orthostatic - Standing, 15 Minutes - Semi-supine, 30 Minutes - Semi-supine, 45 Minutes - Semi-supine, 1 Hour - Semi-supine, 1.5 Hour - Semi-supine, 2 Hours - Semi-supine, 4 Hours - Semi-supine, 6 Hours - Semi-supine, 8 Hours - Semi-supine, 10 Hours - Semi-supine, 10 Hours - Orthostatic- Supine, 10 Hours - Orthostatic- Sitting, 10 Hours - Orthostatic- Standing, 12 Hours - Semi-supine, 24 Hours - Semi-supine, 32 Hours - Semi-supine, 48 Hours - Semi-supine
Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR 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: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904 - Session 2: Vital Signs Form

- 13/12/2018 - 1 Formulaire, 23 Groupes Item, 89 Eléments de données, 1 Langue
Groupes Item: Administrative data, Dosing Date and Time, Predose - Semi-supine, Predose Orthostatic - Supine, Predose Orthostatic - Sitting, Predose Orthostatic - Standing, 15 Minutes - Semi-supine, 30 Minutes - Semi-supine, 45 Minutes - Semi-supine, 1 Hour - Semi-supine, 1.5 Hour - Semi-supine, 2 Hours - Semi-supine, 4 Hours - Semi-supine, 6 Hours - Semi-supine, 8 Hours - Semi-supine, 10 Hours - Semi-supine, 10 Hours - Orthostatic- Supine, 10 Hours - Orthostatic- Sitting, 10 Hours - Orthostatic- Standing, 12 Hours - Semi-supine, 24 Hours - Semi-supine, 32 Hours - Semi-supine, 48 Hours - Semi-supine
Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR 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: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904 - Session 1: Vital Signs Form

- 13/12/2018 - 1 Formulaire, 23 Groupes Item, 89 Eléments de données, 1 Langue
Groupes Item: Administrative data, Dosing Date and Time, Predose - Semi-supine, Predose Orthostatic - Supine, Predose Orthostatic - Sitting, Predose Orthostatic - Standing, 15 Minutes - Semi-supine, 30 Minutes - Semi-supine, 45 Minutes - Semi-supine, 1 Hour - Semi-supine, 1.5 Hour - Semi-supine, 2 Hours - Semi-supine, 4 Hours - Semi-supine, 6 Hours - Semi-supine, 8 Hours - Semi-supine, 10 Hours - Semi-supine, 10 Hours - Orthostatic- Supine, 10 Hours - Orthostatic- Sitting, 10 Hours - Orthostatic- Standing, 12 Hours - Semi-supine, 24 Hours - Semi-supine, 32 Hours - Semi-supine, 48 Hours - Semi-supine
Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR 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: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904 - Vital Signs Form

- 11/12/2018 - 1 Formulaire, 5 Groupes Item, 23 Eléments de données, 1 Langue
Groupes Item: Administrative data, Sitting Vitals Signs, Supine Orthostatic Vitals Signs, Sitting Orthostatic Vitals Signs, Standing Orthostatic Vitals Signs
Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR 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: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837 - Visit 1: Vital Signs Form

- 06/12/2018 - 1 Formulaire, 2 Groupes Item, 9 Eléments de données, 1 Langue
Groupes Item: Administrative data, Vital Signs
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 - Early Term: Vital Signs Form

- 19/11/2018 - 1 Formulaire, 2 Groupes Item, 20 Eléments de données, 1 Langue
Groupes Item: Administrative data, Vital Signs
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

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