Résultats de recherche - Portail des modèles médicaux de données (portail MDM)

Extension balance and metabolic disposition of vilanterol as a single oral dose. 106181 - Screening visit

- 17/09/2021 - 1 Formulaire, 18 Groupes Item, 108 Eléments de données, 1 Langue

Groupes Item: Demography, Vital signs, 12-lead ECG, 12-Lead ECG, Abnormality, Holter Electrocardiography, Summary Report, Holter Electrocardiography, Summary Report, Electrocardiogram abnormal, Medical conditions, Physical Examination, History of Tobacco Use, HIV screen, Alcohol consumption, Drug screen, Ethanol measurement, Laboratory Procedures; Chemistry, Clinical, Laboratory Procedures; Haematologic tests, Laboratory Procedures; Urinalysis, Pharmacokinetic aspects, Blood, Inclusion, Exclusion Criteria

Study ID: 106181 Clinical Study ID: B2C106181 Study Title: An open-label, single-arm study to determine the excretion balance and metabolic disposition of [14C]GW642444 administered as a single dose of an oral solution to healthy male volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01286831 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: vilanterol Trade Name: Study Indication: Pulmonary Disease, Chronic Obstructive

Extension balance and metabolic disposition of vilanterol as a single oral dose. 106181 - Study Period

- 11/12/2018 - 1 Formulaire, 17 Groupes Item, 85 Eléments de données, 1 Langue

Groupes Item: Drug Screen, Ethanol Measurement, Physical Examination, Laboratory Procedures, Chemistry, Clinical, Laboratory Procedures, Hematology finding, Laboratory Procedures, Urinalysis, Pharmacokinetic aspects, Blood, Vital signs, 12-Lead-ECG, 12 lead ECG, Abnormality, Randomization, Numbers, Experimental drug, Therapeutic procedure, Confirmation, Pharmacokinetic aspects, Blood, Pharmacokinetic aspects, Blood, Metabolite, Pharmacokinetic aspects, Urine, Pharmacokinetic aspects, Faeces, Entero string test

Study ID: 106181 Clinical Study ID: B2C106181 Study Title: An open-label, single-arm study to determine the excretion balance and metabolic disposition of [14C]GW642444 administered as a single dose of an oral solution to healthy male volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01286831 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: vilanterol Trade Name: Study Indication: Pulmonary Disease, Chronic Obstructive

Day 56 Early Termination Visit 5 Genzyme Chronic Kidney Disease EudraCT 2005-003233-41

- 16/09/2016 - 1 Formulaire, 3 Groupes Item, 9 Eléments de données, 1 Langue

Groupes Item: Patient administration, Laboratory Evaluations, Vital signs

An open label, dose titration study of sevelamer carbonate tablets dosed three times a day in hyperphosphatemic chronic kidney disease patients not on dialysis Name of Sponsor: Genzyme Europe BV Country: Netherlands https://www.clinicaltrialsregister.eu/ctr-search/trial/2005-003233-41/DE#A

Fluticasone Furoate GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder alone in the treatment of persistent asthma NCT01165138 - Date of Visit/ Assessment, Completion of Visit Assessments (Follow- Up); Date of Visit/ Assessment, Vital signs, Candidiasis Examination, Electronically transferred lab data, Liver Events Assessment (Early Withdrawal)

- 23/11/2018 - 1 Formulaire, 7 Groupes Item, 17 Eléments de données, 1 Langue

Groupes Item: Date of Visit/ Assessment - Follow- Up, Completion of Visit Assessments, Date of Visit/ Assessment - Early Withdrawal, Vital signs, Candidiasis Examination , Electronically transferred lab data , Liver Events Assessment

Study ID: 106827 Clinical Study ID: HZA106827 Study Title: HZA106827:A randomised, double-blind, placebo-controlled (with rescue medication), parallel group multicentre study of Fluticasone Furoate/GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder alone in the treatment of persistent asthma in adults and adolescents Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01165138 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Allermist,Veramyst,Avamys; Relvar Study Indication: Asthma

Fluticasone Furoate GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder alone in the treatment of persistent asthma NCT01165138 - Date of Visit/ Assessment, Vital signs, Candidiasis Examination, Inhaler Ease Of Use Assessment,Device Use Assessment, Subject Withdrawal Status, Electronically transferred lab data, Liver Events Assessment - Visit 5

- 23/11/2018 - 1 Formulaire, 8 Groupes Item, 21 Eléments de données, 1 Langue

Groupes Item: Date of Visit/ Assessment, Vital signs, Candidiasis Examination , Inhaler Ease Of Use Assessment, Device Use Assessment , Subject Withdrawal Status , Electronically transferred lab data , Liver Events Assessment

Study ID: 106827 Clinical Study ID: HZA106827 Study Title: HZA106827:A randomised, double-blind, placebo-controlled (with rescue medication), parallel group multicentre study of Fluticasone Furoate/GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder alone in the treatment of persistent asthma in adults and adolescents Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01165138 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Allermist,Veramyst,Avamys; Relvar Study Indication: Asthma

Fluticasone Furoate GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder alone in the treatment of persistent asthma NCT01165138 - Date of Visit/ Assessment, Vital signs, Candidiasis Examination, Device Use Assessment, Subject Withdrawal Status, Electronically transferred lab data, Liver Events Assessment - Visit 4

- 23/11/2018 - 1 Formulaire, 7 Groupes Item, 19 Eléments de données, 1 Langue

Groupes Item: Date of Visit/ Assessment, Vital signs, Candidiasis Examination , Device Use Assessment , Subject Withdrawal Status , Electronically transferred lab data , Liver Events Assessment

Study ID: 106827 Clinical Study ID: HZA106827 Study Title: HZA106827:A randomised, double-blind, placebo-controlled (with rescue medication), parallel group multicentre study of Fluticasone Furoate/GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder alone in the treatment of persistent asthma in adults and adolescents Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01165138 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Allermist,Veramyst,Avamys; Relvar Study Indication: Asthma

Fluticasone Furoate GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder alone in the treatment of persistent asthma NCT01165138 - Date of Visit/ Assessment, Unscheduled Assessments Performed, Vital signs, Candidiasis Examination, Electronically transferred lab data, Liver Events Assessment (Unscheduled); Date of Visit/ Assessment, Status of Treatment Blind, Pregnancy Information, Pharmacogenetic (PGx) Research Withdrawal of Consent, Study Conclusion, Investigator Signature (End of Study)

- 23/11/2018 - 1 Formulaire, 12 Groupes Item, 33 Eléments de données, 1 Langue

Groupes Item: Date of Visit/ Assessment - Unscheduled, Unscheduled Assessments Performed, Vital signs, Candidiasis Examination , Electronically transferred lab data , Liver Events Assessment , Date of Visit/ Assessment - End of Study, Status of Treatment Blind, Pregnancy Information, Pharmacogenetic (PGx) Research Withdrawal of Consent, Study Conclusion, Investigator Siganture

Study ID: 106827 Clinical Study ID: HZA106827 Study Title: HZA106827:A randomised, double-blind, placebo-controlled (with rescue medication), parallel group multicentre study of Fluticasone Furoate/GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder alone in the treatment of persistent asthma in adults and adolescents Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01165138 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Allermist,Veramyst,Avamys; Relvar Study Indication: Asthma

Fluticasone Furoate GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder alone in the treatment of persistent asthma NCT01165138 - Date of Visit/ Assessment, Investigational Product, Vital signs, Candidiasis Examination, PK Sample, Subject Withdrawal Status, Electronically transferred lab data, Liver Events Assessment- Visit 6

- 23/11/2018 - 1 Formulaire, 10 Groupes Item, 24 Eléments de données, 1 Langue

Groupes Item: Date of Visit/ Assessment, Investigational Product, Vital signs, Candidiasis Examination , PK Sample- Pre Dose, PK Sample - 15 Minutes Post- Dose, PK Sample PK Sample - 1.5 Hours Post- Dose , Subject Withdrawal Status , Electronically transferred lab data , Liver Events Assessment

Study ID: 106827 Clinical Study ID: HZA106827 Study Title: HZA106827:A randomised, double-blind, placebo-controlled (with rescue medication), parallel group multicentre study of Fluticasone Furoate/GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder alone in the treatment of persistent asthma in adults and adolescents Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01165138 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Allermist,Veramyst,Avamys; Relvar Study Indication: Asthma

Fluticasone Furoate GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder alone in the treatment of persistent asthma NCT01165138 - Visit Assessments Complete (Visit 2) and Run-In-Failure, Randomisation Criteria, ICS/ LABA Concomitant Medications, Randomisation Number, Investigational Product, Vital Signs, Electronically Transferred Lab Data, Device Use Assessment, Subject Withdrawal Status and Liver Events Assessment(Visit 3)

- 21/11/2018 - 1 Formulaire, 18 Groupes Item, 47 Eléments de données, 1 Langue

Groupes Item: Date of Visit/ Assessment , Completion of Visit Assessments, Run- In Failure, Investigator Siganture , Date of Visit/ Assessment , Randomisation Criteria, Run- In Failure , Investigator Siganture , ICS/ LABA Concomitant Medications, Randomisation Number, Investigatinal Product, Vital Signs, Candidiasis Examination, Electronically transferred lab data, Device Use Assessment, Subject Withdrawal Status, Electronically transferred lab data , Liver Events Assessment

Study ID: 106827 Clinical Study ID: HZA106827 Study Title: HZA106827:A randomised, double-blind, placebo-controlled (with rescue medication), parallel group multicentre study of Fluticasone Furoate/GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder alone in the treatment of persistent asthma in adults and adolescents Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01165138 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Allermist,Veramyst,Avamys; Relvar Study Indication: Asthma

Fluticasone Furoate GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder alone in the treatment of persistent asthma NCT01165138 - Date of Vsit/ Assessment, Investigational Product, Vital signs, Candidiasis Examination, Electronically transferred lab data, Liver Events Assessment , PK Sample- Pre Dose, PK Sample, Subject Withdrawal Status - Visit 7

- 23/11/2018 - 1 Formulaire, 10 Groupes Item, 27 Eléments de données, 1 Langue

Groupes Item: Date of Visit/ Assessment, Investigational Product, Vital signs, Candidiasis Examination , Electronically transferred lab data , Liver Events Assessment , PK Sample- Pre Dose, PK Sample - 15 Minutes Post- Dose, PK Sample - 1.5 Hours Post- Dose , Subject Withdrawal Status

Study ID: 106827 Clinical Study ID: HZA106827 Study Title: HZA106827:A randomised, double-blind, placebo-controlled (with rescue medication), parallel group multicentre study of Fluticasone Furoate/GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder alone in the treatment of persistent asthma in adults and adolescents Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01165138 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Allermist,Veramyst,Avamys; Relvar Study Indication: Asthma

GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630 - Physical examination - Treatment Period 2, Day 1, Pre-dose

- 11/04/2018 - 1 Formulaire, 2 Groupes Item, 11 Eléments de données, 1 Langue

Groupes Item: Vital Signs, Pedal Oedema

Study ID: 104385 Clinical Study ID: RES104385 Study Title: A randomised double-blind two-period crossover study to investigate the effect of treatment with repeat doses of a PPAR gamma agonist on the allergen-induced late asthmatic response in subjects with mild asthma compared with repeat doses of placebo Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00318630 https://clinicaltrials.gov/ct2/show/NCT00318630 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Rosiglitazone XR,Avandia XR,Avandia Study Indication: Asthma This ODM-file contains Physical Examination: Vital Signs, pedal oedema. Time: Treatment Period 2, Day 1, pre-dose.

GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630 - Physical examination - Treatment Period 1, Day 29

- 10/04/2018 - 1 Formulaire, 2 Groupes Item, 11 Eléments de données, 1 Langue

Groupes Item: Vital Signs, Pedal Oedema

Study ID: 104385 Clinical Study ID: RES104385 Study Title: A randomised double-blind two-period crossover study to investigate the effect of treatment with repeat doses of a PPAR gamma agonist on the allergen-induced late asthmatic response in subjects with mild asthma compared with repeat doses of placebo Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00318630 https://clinicaltrials.gov/ct2/show/NCT00318630 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Rosiglitazone XR,Avandia XR,Avandia Study Indication: Asthma This ODM-file contains Physical Examination: Vital Signs, pedal oedema. Time: Treatment Period 1, Day 29.

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