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Geselecteerde datamodellen

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8 Zoekresultaten.
Relevantie Beoordeling Nieuwe eerst Oude eerst

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085 - Liver Imaging Form 1

- 21-11-18 - 1 Formulier, 3 Itemgroepen, 13 Data-elementen, 1 Taal
Itemgroepen: Administrative data, Complete a separate form for each individual imaging test performed., Image Quality
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

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085 - Pancreatitis Diagnostic Studies

- 19-11-18 - 1 Formulier, 4 Itemgroepen, 25 Data-elementen, 1 Taal
Itemgroepen: Administrative data, Abdominal Ultrasound, CT Scan, MRI
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

Eligibility Diabetes Mellitus, Type 2 NCT01705210

- 03-11-19 - 1 Formulier, 2 Itemgroepen, 21 Data-elementen, 1 Taal
Itemgroepen: Inclusion Criteria, Exclusion Criteria
Functional MRI Biomarkers of Cognitive Decrements in Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01705210

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085 - Liver Biopsy Data

- 20-11-18 - 1 Formulier, 5 Itemgroepen, 38 Data-elementen, 1 Taal
Itemgroepen: Administrative data, Liver Biopsy, C. Description of Liver Cells or Hepatocytes, D. Liver Cells or Hepatocyte Inclusions or Vacuoles, E. Hepatocyte or Liver Cell Nuclear Abnormalities
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

Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032 - Adjudication Events - Heart Failure

- 04-01-19 - 1 Formulier, 15 Itemgroepen, 86 Data-elementen, 1 Taal
Itemgroepen: Administrative data, Hospitalization for Heart Failure, Clinical Symptoms of Heart Failure, Investigative Evidence of Structural or Functional Heart Disease, Chest X-Ray, Echocardiography, Left ventricular systolic dysfunction / impairment, Significant valvular heart disease, BNP (B-type natriuretic peptide) or NT-proBNP (N-terminal proBNP), Peak BNP/NT-proBNP value + the laboratory upper reference limit, BNP, NT-proBNP, Other Investigations, Treatment, Description of Event
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 - Various Adverse Events: Hypoglycemia, Injection Site Reaction, Pancreatitis, Thyroid Nodes

- 02-01-19 - 1 Formulier, 37 Itemgroepen, 183 Data-elementen, 1 Taal
Itemgroepen: Administrative data, (Serious) Hypoglycaemic Events, Serious Adverse Events, Injection Site Reaction, Pancreatitis, Symptoms of Gastrointestinal Illness Associated with Pancreatitis, Pain in the Epigastrium, Pain in the Periumbical Region, Pain in the Right Upper Quadrant, Pain in the Left Upper Quadrant, Pain in the Left Lower Quadrant, Pain in the Right Lower Quadrant, Pain in the Right Flank, Pain in the Left Flank, Pain in the Back, Other Symptoms, Nausea, Vomiting, Fever, Biochemistry, Alkaline phosphatase, Total bilirubin, Direct bilirubin, Creatinine, Other lab test, Diagnostic Studies - Pancreatitis, Abdominal CT Scan, MRI, New Thyroid Nodules, Bidimensional Measurement, Thyroid Nodules AE Details, Thyroid function tests, Free T4, T4, TSH, Free T3, T3 Uptake
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 - Adjudication Events - Stroke / TIA

- 07-01-19 - 1 Formulier, 10 Itemgroepen, 71 Data-elementen, 1 Taal
Itemgroepen: Administrative data, Stroke / TIA, Neurological Signs / Symptoms, Neurological Signs / Symptoms Tendencies, Diagnostic Investigations - CT Brain Scan, Diagnostic Investigations - MRI Brain Scan, Diagnostic Investigations - Cerebral Angiography, Diagnostic Investigations - Lumbar Puncture, Final Clinical Diagnosis, Narrative
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 study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin - Liver Biopsy - Repeating Form, Liver Event 8-RF-DF

- 07-06-20 - 1 Formulier, 14 Itemgroepen, 156 Data-elementen, 1 Taal
Itemgroepen: Date of liver biopsy, Liver Biopsy size, Liver Biopsy Final Diagnosis, Liver Architecture, Description of Liver Cells or Hepatocytes, Liver Cell or Hepatocyte Inclusions or Vacuoles, Hepatocyte or Liver Cell Nuclear Abnormalities, Liver or Lobular Infiltrates, Portal Tract Inflammation, Bile Ducts, Portal Veins, Liver Infections, Liver: Parasites or Ova, Histologic Staining or Additional Studies Obtained
The primary focus of this first time in human (FTIH) study was to evaluate the safety and tolerability of GSK1292263 and to estimate GSK1292263 pharmacokinetic (PK) parameters and pharmacodynamic (PD) effects in healthy volunteers. Subject: FTIH, oral, safety, tolerability, pharmacokinetics, glucose, pharmacodynamics, male, female, gastric emptying Indication Studied: Type 2 Diabetes Mellitus Study ID: 111596 Clinical Study ID: 111596 Study Title: A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00783549 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK1292263, Sitagliptin Trade Name: N/A Study Indication: Dyslipidaemias

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