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

GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122 - 12-Lead ECG Abnormalities

- 17/12/2020 - 1 Formulaire, 8 Groupes Item, 90 Eléments de données, 1 Langue

Groupes Item: Administrative Data, 12-Lead ECG Abnormalities, 12-Lead ECG Rhythm, 12-Lead ECG, P-Wave Morphology, Conduction, Myocardial Infarction, Depolarisation/Repolarisation (QRS-T), ECG, Other abnormalities

The primary objective of this study was to demonstrate bioequivalence between eltrombopag oral film-coated tablets manufactured at Research and Development (R&D) and Commercial sites. The subject participants each went through two dosing periods (Period 1 and Period 2), during each of which they received a single dose of eltrombopag. The dosing periods were separated by a washout of at least 10 days. For each period, subjects had to perform a visit on the day before and one on the day of the administration of the drug. Furthermore, the protocol-defined visits included a screening visit and a follow-up visit. Study ID: 105122 Clinical Study ID: 105122 Study Title: Phase I Bioequivalence Study for SB 497115 GR Phase II and Phase III Tablets Sponsor: GlaxoSmithKline Phase: phase 1 Study Recruitment Status: Completed Generic Name: Eltrombopag Study Indication: Thrombocytopenia The 12-Lead ECG Abnormalities Form has to be filled in whenever an abnormal ECG curve is recorded durig the study. ECG curves are recorded during the Screening, P1 D1, P2 D1, Follow-Up and Repeat Visits.

Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673 - Logs and Repeats - Pharmacokinetics Blood; Local Laboratory; Summary Holter; Holter Abnormalities

- 13/12/2020 - 1 Formulaire, 6 Groupes Item, 37 Eléments de données, 1 Langue

Groupes Item: Pharmacokinetics Blood, Pulmonary Function Tests, Local Laboratory, Summary Holter, Holter Abnormalities, Holter Abnormalities

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

GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122 - 12-Lead ECG

- 12/12/2020 - 1 Formulaire, 3 Groupes Item, 13 Eléments de données, 1 Langue

Groupes Item: Administrative Data, Dosing date and time, 12-Lead ECG

The primary objective of this study was to demonstrate bioequivalence between eltrombopag oral film-coated tablets manufactured at Research and Development (R&D) and Commercial sites. The subject participants each went through two dosing periods (Period 1 and Period 2), during each of which they received a single dose of eltrombopag. The dosing periods were separated by a washout of at least 10 days. For each period, subjects had to perform a visit on the day before and one on the day of the administration of the drug. Furthermore, the protocol-defined visits included a screening visit and a follow-up visit. Study ID: 105122 Clinical Study ID: 105122 Study Title: Phase I Bioequivalence Study for SB 497115 GR Phase II and Phase III Tablets Sponsor: GlaxoSmithKline Phase: phase 1 Study Recruitment Status: Completed Generic Name: Eltrombopag Study Indication: Thrombocytopenia This form has to be filled out at the Screening Visit, the P1 D1 and P2 D1, the Follow-Up Visit and whenever a repeat ECG measurement was conducted during the study.

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

- 05/12/2020 - 1 Formulaire, 9 Groupes Item, 36 Eléments de données, 1 Langue

Groupes Item: 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

Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673 - Screening - Summary Holter; Holter Abnormalities

- 30/11/2020 - 1 Formulaire, 3 Groupes Item, 22 Eléments de données, 1 Langue

Groupes Item: Summary Holter, Holter Abnormalities, Holter Abnormalities

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

Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673 - Screening - ECG; Vital Signs

- 29/11/2020 - 1 Formulaire, 4 Groupes Item, 20 Eléments de données, 1 Langue

Groupes Item: Date of Visit/ Assessment , ECG (semi-recumbent position), Vital Signs (semi-recumbent position), Vital Signs (semi-recumbent position)

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

Pharmacokinetics of Simvastatin When Coadministered With Albiglutide NCT01147692 - Screening - Informed Consent; Admission Criteria; Demographics; Electocardiogram; Central Laboratory

- 29/11/2020 - 1 Formulaire, 10 Groupes Item, 48 Eléments de données, 1 Langue

Groupes Item: Administrative, Informed Consent, Admission Criteria, Admission Criteria , Demographics, Electrocardiogram, Central Laboratory - Haematology, Central Laboratory - Chemistry/ Serum HCG/ SP Chem, Central Laboratory - UA/ UDS/ Urine Chem , Central Laboratory - Serology

Study ID: 108366 Clinical Study ID: 108366 Study Title: An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Simvastatin When Coadministered With Albiglutide in Healthy Adult Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01147692 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: simvastatin plus albiglutide Trade Name: simvastatin plus albiglutide Study Indication: Diabetes Mellitus, Type 2

Pharmacokinetics of Simvastatin When Coadministered With Albiglutide NCT01147692 - Day -1 - Admission Criteria; Vital Signs; Electrocardiogram; Central Laboratory

- 29/11/2020 - 1 Formulaire, 7 Groupes Item, 39 Eléments de données, 1 Langue

Groupes Item: Administrative, Admission Criteria, Vital Signs (sitting) , Electrocardiogram, Central Laboratory - Haematology , Central Laboratory - Chemistry, Central Laboratory - UA/ UDS/ Urine HCG/ Urine Chem

Study ID: 108366 Clinical Study ID: 108366 Study Title: An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Simvastatin When Coadministered With Albiglutide in Healthy Adult Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01147692 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: simvastatin plus albiglutide Trade Name: simvastatin plus albiglutide Study Indication: Diabetes Mellitus, Type 2

Pharmacokinetics of Simvastatin When Coadministered With Albiglutide NCT01147692 - Day 7 - 35: Vital Signs; Study Drug Administration; Pharmacokinetic Blood Collection (Albiglutide), Electrocardiogram

- 29/11/2020 - 1 Formulaire, 5 Groupes Item, 35 Eléments de données, 1 Langue

Groupes Item: Administrative, Vital Signs (sitting) - Day 7 - 35, Study Drug Administration (50 mg Albiglutide) - Day 7 - 35, Pharmacokinetic Blood Collection (Albiglutide) - Day 35, Electrocardiogram (Day 14)

Study ID: 108366 Clinical Study ID: 108366 Study Title: An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Simvastatin When Coadministered With Albiglutide in Healthy Adult Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01147692 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: simvastatin plus albiglutide Trade Name: simvastatin plus albiglutide Study Indication: Diabetes Mellitus, Type 2

Lapatinib + Topotecan or + Capecitabine in Recurrent Brain Metastases from Breast Cancer; NCT00437073 - Screening

- 13/10/2020 - 1 Formulaire, 24 Groupes Item, 273 Eléments de données, 1 Langue

Groupes Item: Date of visit, Assessment Date, Trial Screening, Enrollment, Clinical Trial Subject Unique Identifier, Demography, Eligibility Determination, Inclusion, Exclusion Criteria, disease characteristic, disease characteristic, Neoplasm Metastasis, Electrocardiography, Echocardiography; Multiple gated acquisition scanning, Laboratory Procedures, Central Laboratory; Laboratory Procedures, Local, Laboratory Procedures, Chemistry, Clinical, Laboratory Procedures, Hematology finding, Central Laboratory, Data, Disease, Operative Surgical Procedures, Disease, Relationships, Disease, Clinical Trials, Therapeutic procedures, Relationships, Disease, Cancer treatment, Prior Therapy, Neurologic Examination, Vital signs, Prior Radiation Therapy, Prior Radiation Therapy, Central Nervous System

Study ID: 107671 Clinical Study ID: 107671 Study Title: EGF107671 – A Phase II Study of Lapatinib plus Topotecan or Lapatinib plus Capecitabine in the Treatment of Recurrent Brain Metastases from ErbB2-Positive Breast Cancer Following Cranial Radiotherapy Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00437073 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: N/A Trade Name: capecitabine, topotecan, lapatinib Study Indication: Neoplasms, Breast; Recurrent Brain Metastases

Effects of Esomeprazole on Lapatinib in Subjects with Breast Cancer; 109275 - Logs/Repeats

- 13/08/2020 - 1 Formulaire, 10 Groupes Item, 157 Eléments de données, 1 Langue

Groupes Item: Event Log, Repeat, Echocardiography, Multiple gated acquisition scanning, Vital signs, Repeat, 12 lead ECG, Unscheduled, Repeat, 12 lead ECG, Abnormality, Pharmacokinetic aspects, Unscheduled, Repeat, Experimental drug, Unscheduled, Repeat, Adverse event, Repeat, Serious Adverse Event, Concomitant Agent, Repeat

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

Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK233705 and tiotropium bromide (103471) - 12-Lead ECG Abnormalities; Holter ECG Abnormalities; ECG Abnormalities (Lead II Monitoring)

- 27/07/2020 - 1 Formulaire, 7 Groupes Item, 43 Eléments de données, 1 Langue

Groupes Item: Administrative, 12-Lead ECG Abnormalities, 12-Lead ECG Abnormalities, Holter ECG Abnormalities, 12-Lead ECG Abnormalities , ECG Abnormalities (Lead II Monitoring), ECG Abnormalities (Lead II Monitoring)

Study ID: 103471 Clinical Study ID: 103471 Study Title: A randomised, double blind, placebo-controlled, double dummy, five-way cross over dose-escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single inhaled doses of GSK233705 (20-500µg via DPI), and, tiotropium bromide (18µg via DPI) in healthy male subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Darotropium Bromide Trade Name: Darotropium Bromide Study Indication: Chronic Obstructive Pulmonary Disease (COPD)

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