Suchergebnisse - Portal für Medizinische Datenmodelle (MDM-Portal)

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

- 17.09.21 - 1 Formular, 18 Itemgruppen, 108 Datenelemente, 1 Sprache

Itemgruppen: 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

- 11.12.18 - 1 Formular, 17 Itemgruppen, 85 Datenelemente, 1 Sprache

Itemgruppen: 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

GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630 - Screening Part 4 - ECG and Pulmonary function (exhaled nitric oxide and AMP Challenge)

- 10.04.18 - 1 Formular, 7 Itemgruppen, 43 Datenelemente, 1 Sprache

Itemgruppen: 12-Lead ECG, Exhaled nitric oxide, Pulmonary function tests / FEV 1, Pulmonary function tests: Pre-AMP Challenge, Pulmonary function tests: AMP Challenge, Pulmonary function tests: Post-AMP Challenge, PC20 (AMP Challenge)

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 Screening Part 4 - ECG and Pulmonary function parts Exhaled nitric oxide and AMP Challenge.

A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837 - 12-LEAD ECG

- 28.11.18 - 1 Formular, 1 Itemgruppe, 12 Datenelemente, 1 Sprache

Itemgruppe: 12-lead ECG

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

Electrocardiogram Abnormalities Form - GSK Milveterol COPD 100527

- 20.09.21 - 1 Formular, 1 Itemgruppe, 11 Datenelemente, 1 Sprache

Itemgruppe: Electrocardiogram Abnormalities

Study ID: 100527 Clinical Study ID: B2E100527 Study Title: A randomised, double blind, placebo controlled, parellel group study to examine the efficacy, safety, tolerability and systemic pharmacokinetic profile of repeated inhaled doses of GSK159797 Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: milveterol Trade Name: Milveterol Study Indication: Pulmonary Disease, Chronic Obstructive

GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630 - ECG Abnormalities Form Part 2

- 06.04.18 - 1 Formular, 4 Itemgruppen, 48 Datenelemente, 1 Sprache

Itemgruppen: Conduction, Myocardial infarction, Depolarisation/Repolarisation, QRS-T, Other abnormalities

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 ECG Abnormalities Form Part 2.

GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630 - ECG Abnormalities Form Part 1

- 06.04.18 - 1 Formular, 3 Itemgruppen, 41 Datenelemente, 1 Sprache

Itemgruppen: Date and Time of ECG, Rhythm, P-wave and QRS morphology

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 ECG Abnormalities Form Part 1.

Effect of one week repeat dosing of GW685698X and FP on serum cortisol (103096) - Screening - 12 Lead ECG; 12-Lead ECG Abnormalities; Pulmonary Function Tests; Inhaler Device Training

- 09.01.21 - 1 Formular, 6 Itemgruppen, 36 Datenelemente, 1 Sprache

Itemgruppen: Administrative, 12-Lead ECG, 12-Lead ECG Abnormalities, 12-Lead ECG Abnormalities , Pulmonary Function Tests, Inhaler Device Training

Study ID: 103096 Clinical Study ID: 103096 Study Title: A randomised, double blind, placebo controlled, incomplete block, five-way cross-over study to investigate the effect of one week repeat dosing of GW685698X and FP on twenty-four hour serum cortisol in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Fluticasone Furoate;Fluticasone Propionate Trade Name: Fluticasone Furoate;Fluticasone Propionate Study Indication: Asthma

Effect of one week repeat dosing of GW685698X and FP on serum cortisol (103096) - Day 1 - Vital Signs; 12-Lead ECG; Pulmonary Function Tests; Pharmacodynamics; Local Laboratory; Urinalysis; Randomisation Number

- 22.01.21 - 1 Formular, 16 Itemgruppen, 57 Datenelemente, 1 Sprache

Itemgruppen: Administrative, Vital Signs - Pre-Dose, 12-Lead ECG (Pre-Dose), 12-Lead ECG Abnormalities , 12-Lead ECG Abnormalities, Pulmonary Function Tests (Pre-Dose), Pharmacodynamics - Blood Sample (Pre-Dose), Local Laboratory - Clinical Chemistry, Local Laboratory - Clinical Chemistry , Local Laboratory - Haematology, Local Laboratory - Haematology , Urinalysis - Local, Urinalysis - Local , Urinalysis Microscopy Test, Urinalysis Microscopy Test, Randomisation Number

Study ID: 103096 Clinical Study ID: 103096 Study Title: A randomised, double blind, placebo controlled, incomplete block, five-way cross-over study to investigate the effect of one week repeat dosing of GW685698X and FP on twenty-four hour serum cortisol in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Fluticasone Furoate;Fluticasone Propionate Trade Name: Fluticasone Furoate;Fluticasone Propionate Study Indication: Asthma

Effect of one week repeat dosing of GW685698X and FP on serum cortisol (103096) - Treatment Period 1- 5 - Investigational Product; Treatment Confirmation; Carbon Monoxide Test; Urine Test for Drugs of Abuse; Vital Signs; 12-Lead ECG; Pulmonary Function Test

- 08.02.21 - 1 Formular, 11 Itemgruppen, 54 Datenelemente, 1 Sprache

Itemgruppen: Administrative, Investigational Product Day 1 - 7, Treatment Corfirmation Day 1 - 7, Carbon Monoxide Test - Day 6 PM, Urine Test for Drugs of Abuse, Urine Test for Drugs of Abuse , Vital Signs - Day 7, 12-Lead ECG - Day 7, 12-Lead ECG Abnormalities - Day 7, 12-Lead ECG Abnormalities - Day 7, Pulmonary Function Test - Day 7

Study ID: 103096 Clinical Study ID: 103096 Study Title: A randomised, double blind, placebo controlled, incomplete block, five-way cross-over study to investigate the effect of one week repeat dosing of GW685698X and FP on twenty-four hour serum cortisol in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Fluticasone Furoate;Fluticasone Propionate Trade Name: Fluticasone Furoate;Fluticasone Propionate Study Indication: Asthma

Oral Topotecan as Radiosensitizing Agent in Patients with Rectal Cancer; NCT00158886 - Post RT/Prior to Surgery

- 19.08.19 - 1 Formular, 4 Itemgruppen, 14 Datenelemente, 1 Sprache

Itemgruppen: Administrative documentation, Serious Adverse Event, 12 lead ECG, Experimental drug, Compliance behavior

Study ID: 104864/517 Clinical Study ID: 104864/517 Study Title: A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158886 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Topotecan + Radiation therapy Trade Name: N/A Study Indication: Rectal Cancer, Carcinoma, Renal Cell

Effect of one week repeat dosing of GW685698X and FP on serum cortisol (103096) - Follow-Up - Vital Signs; 12-Lead ECG; Pulmonary Function Tests; Pregnancy Test; Local Laboratory; Urinalysis

- 15.02.21 - 1 Formular, 15 Itemgruppen, 54 Datenelemente, 1 Sprache

Itemgruppen: Administrative, Vital Signs, 12-Lead ECG, 12-Lead ECG Abnormalities, 12-Lead ECG Abnormalities, Pulmonary Function Test - Pre-Dose, Pregnancy Test, Local Laboratory - Clinical Chemistry, Local Laboratory - Clinical Chemistry, Local Laboratory - Haematology, Local Laboratory - Haematology, Urinalysis - Local, Urinalysis - Local, Urinalysis - Microscopy, Urinalysis - Microscopy

Study ID: 103096 Clinical Study ID: 103096 Study Title: A randomised, double blind, placebo controlled, incomplete block, five-way cross-over study to investigate the effect of one week repeat dosing of GW685698X and FP on twenty-four hour serum cortisol in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Fluticasone Furoate;Fluticasone Propionate Trade Name: Fluticasone Furoate;Fluticasone Propionate Study Indication: Asthma

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