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Pharmacokinetics of Simvastatin When Coadministered With Albiglutide NCT01147692 - Screening - Vital Signs; General Medical History; Physical Exam

- 2020-11-29 - 1 form, 5 itemgroups, 25 items, 1 language
Itemgroups: Administrative, Vital Signs (sitting), General Medical History, Physical Exam, Physical Exam
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

Subcutaneous injections of GSK 716155 in healthy volunteers; Study ID: 105229 - Screening

- 2018-11-06 - 1 form, 14 itemgroups, 67 items, 1 language
Itemgroups: Demography, Childbearing Potential, Physical Examination, Medical Conditions, Vital Signs, 12-lead ECG, Holter Electrocardiography, Clinical Chemistry, Hematology finding, Urinalysis, Immunogenicity Study; Blood, Urine drug screening, Ethanol measurement, Urine; Ethanol measurement, breath, HIV Seropositivity, hepatitis b serology, hepatitis C serology test
Study ID: 105229 Clinical Study ID: GLP105229 Study Title: A double-blinded, randomized, placebo-controlled, staggered-parallel, escalating dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous injections of GSK 716155 in healthy volunteers. 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: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Subcutaneous injections of GSK 716155 in healthy volunteers; Study ID: 105229 - Final Follow-Up

- 2018-10-09 - 1 form, 9 itemgroups, 30 items, 1 language
Itemgroups: 12-lead ECG, Vital Signs, Physical Examination, Clinical Chemistry, Hematology finding, Urinalysis, Fructosamine measurement, Immunogenicity Study; Blood, Pharmacokinetic aspects; Blood
Study ID: 105229 Clinical Study ID: GLP105229 Study Title: A double-blinded, randomized, placebo-controlled, staggered-parallel, escalating dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous injections of GSK 716155 in healthy volunteers. 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: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Subcutaneous injections of GSK 716155 in healthy volunteers; Study ID: 105229 - Day 13

- 2018-10-09 - 1 form, 14 itemgroups, 51 items, 1 language
Itemgroups: 12-lead ECG, Vital Signs, Physical Examination, Clinical Chemistry, Hematology finding, Urinalysis, Free Fatty Acids measurement, Fructosamine measurement, Capillary Blood Glucose measurement, drug biological activity, Collection of blood specimen for laboratory procedure, Pharmacokinetic aspects; Blood, Antidiabetics; Tolerability Study, Adverse event, Antidiabetics; Tolerability Study; Worksheet
Study ID: 105229 Clinical Study ID: GLP105229 Study Title: A double-blinded, randomized, placebo-controlled, staggered-parallel, escalating dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous injections of GSK 716155 in healthy volunteers. 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: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Screening and Observation Period UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952

- 2016-11-02 - 1 form, 8 itemgroups, 61 items, 2 languages
Itemgroups: In-/Exclusion Criteria, Demographics, Vital Signs and Examinations, Circulatory Symptoms, One year transfusion history, Preexisting and concomitant diseases, Preexisting and concomitant, Visit 0 - FACIT, Visit 0 - SF36
Study Type: Interventional Study Design: Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment Official Title: Therapy for Chronic Cold Agglutinin Disease: A Prospective, Non-Randomized Multi-Center Study Demonstrating the Efficacy of Terminal Complement Inhibition in Patients With Cold Agglutinin Disease Using Eculizumab EudraCT-Nummer 2009-01696697 ClinicalTrials.gov-Identifier NCT01303952 https://clinicaltrials.gov/ct2/show/NCT01303952 Genehmigung durch Frau Ose

Early Termination Visit - Visit 17 UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952

- 2016-10-25 - 1 form, 9 itemgroups, 37 items, 2 languages
Itemgroups: Date of Visit, LDH, Weight, Vital signs, Examinations, Six-Minute Walk Test, Circulatory Symptoms, Study medication, Signature principal investigator
Study Type: Interventional Study Design: Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment Official Title: Therapy for Chronic Cold Agglutinin Disease: A Prospective, Non-Randomized Multi-Center Study Demonstrating the Efficacy of Terminal Complement Inhibition in Patients With Cold Agglutinin Disease Using Eculizumab EudraCT-Nummer 2009-01696697 ClinicalTrials.gov-Identifier NCT01303952 https://clinicaltrials.gov/ct2/show/NCT01303952 Genehmigung durch Frau Ose

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