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

Liver biopsy GSK study Chronic Coronary Heart Disease NCT00799903

- 06/12/2018 - 1 Formulaire, 14 Groupes Item, 157 Eléments de données, 1 Langue

Groupes Item: 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

Study ID: 100601 Clinical Study ID: LPL100601 Study Title: LPL100601, A Clinical Outcomes Study of Darapladib versus Placebo in Subjects with Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00799903 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: darapladib Study Indication: Atherosclerosis Study part: Liver biopsy - Repeating form (Unscheduled/Dynamic visit)

Safety, Tolerability and Pharmacokinetics of GSK1399686 After Single and Repeated Oral Dosing NCT00721812 - Liver Assessment; Liver Biopsy; Liver Events; Liver Imaging

- 26/05/2021 - 1 Formulaire, 10 Groupes Item, 76 Eléments de données, 1 Langue

Groupes Item: Administrative, Liver Events Assessment, Liver Biopsy, Liver Events, Alcohol Intake, Liver Disease Medical Conditions, Drug Related Liver Disease Conditions, Other Liver Disease Conditions, Other Medical Conditions, Liver Imaging

Study ID: 111406 Clinical Study ID: 111406 Study Title: A First-Time-in-Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1399686 After Single and Repeated Oral Dosing in Healthy Volunteers using a Dose- Escalating, Randomized, Placebo-Controlled Study Design Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00721812 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Placebo, locally-acting anti-inflammatory compound GSK1399686 Study Indication: Inflammatory Bowel Diseases

Safety, tolerability and pharmacodynamics of Elubrixin in cystic fibrosis patients, NCT00903201 - Liver biopsy

- 26/02/2020 - 1 Formulaire, 14 Groupes Item, 158 Eléments de données, 1 Langue

Groupes Item: Administrative data, 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, Parasites or Ova, Histologic Staining or Additional Studies Obtained

Study ID: 110399 Clinical Study ID: 110399 Study Title: A randomized, double blind, parallel group, placebo controlled 28 day study to investigate the safety, tolerability and pharmacodynamics of SB-656933 in subjects with cystic fibrosis. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00903201 https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB656933, Placebo Trade Name: N/A Study Indication: Cystic Fibrosis The study consists of a screening, five study visits and a follow-up (time relative to Baseline in days): Visit 1: Screening, Day -28 to -16 Visit 2a: Day -7 to -4 Visit 2b: Day 1 Visit 3: Day 14 Visit 4: Day 21 Visit 5: Day 28 Visit 6: Early Withdrawal/ Follow-up, Day 35 to 42. From day 1 to day 28 the patients will receive daily doses. This document contains the liver biopsy form. It has to be filled in if a liver biopsy is taken during the study.

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

- 07/06/2020 - 1 Formulaire, 14 Groupes Item, 156 Eléments de données, 1 Langue

Groupes Item: 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

Safety, tolerability and pharmacokinetics of single, ascending and twice-daily repeat doses of intranasal SB-705498 NCT00907933 - Liver Event - Liver Events; Investigational Product (Liver); Pharmacokinetics (Liver); Medical Conditions; Alcohol Intake (Liver Alcohol); Liver Imaging; Liver Biopsy

- 31/10/2019 - 1 Formulaire, 10 Groupes Item, 102 Eléments de données, 1 Langue

Groupes Item: Liver Events, Investigational Product (Liver), Pharmacokinetics (Liver PK), Medical Conditions (Liver), Drug related liver disease conditions, Other liver disease conditions, Other medical conditions, Alcohol intake, Liver imaging, Liver Biopsy

Study ID: 111610 Clinical Study ID: 111610 Study Title: A randomised, double-blind, placebo-controlled study in healthy volunteers to examine the safety, tolerability and pharmacokinetics of a) single, ascending and b) twice-daily repeat doses of intranasal SB-705498. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00907933 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB705498, Placebo Study Indication: Rhinitis

Brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand NCT00814957 - Liver Event - Liver Events; Investigational Product (Liver); Pharmacokinetics (Liver); Medical Conditions; Alcohol Intake (Liver Alcohol); Liver Imaging; Liver Biopsy

- 04/08/2019 - 1 Formulaire, 11 Groupes Item, 103 Eléments de données, 1 Langue

Groupes Item: Date of visit/ date of assessment, Liver Events, Investigational Product (Liver), Pharmacokinetics (Liver PK), Medical Conditions (Liver), Drug related liver disease conditions, Other liver disease conditions, Other medical conditions, Alcohol intake, Liver imaging, Liver Biopsy

Study ID: 110269 Clinical Study ID: 110269 Study Title: An open label positron emission tomography study in healthy male subjects to investigate brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00814957 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: positron emission tomography, GSK618334 Study Indication: Substance Dependence

Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer NCT00549328 - Liver Events; Investigational Product (Liver); Alcohol Intake (Liver Alcohol); Medical Conditions; Pharmacokinetics (Liver); Liver Biopsy; Liver Imaging

- 02/08/2019 - 1 Formulaire, 10 Groupes Item, 102 Eléments de données, 1 Langue

Groupes Item: Liver Events, Investigational Product (Liver) , Alcohol intake, Medical Conditions (Liver), Drug related liver disease conditions, Other liver disease conditions, Other medical conditions, Pharmacokinetics (Liver PK), Liver Biopsy, Liver imaging

Study ID: 109609 Clinical Study ID: 109609 Study Title: A Phase II, Non-randomized, Multi-center Study to Evaluate the Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00549328 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GW786034 Trade Name: Drug: Pazopanib Study Indication: Lung Cancer, Non-Small Cell

Emotional processing in healthy male volunteers treated with GSK424887 NCT01424384 - Liver Event DoV, Liver Events, Investigational product (liver), Pharmacokinetics (liver), Medical conditions (liver), Alcohol intake, Liver imaging repeating, Liver biopsy

- 14/09/2018 - 1 Formulaire, 10 Groupes Item, 92 Eléments de données, 1 Langue

Study ID: 105012 Clinical Study ID: NSS105012 Study Title: Emotional processing in healthy male volunteers treated with GSK424887. A single centre, randomised, double-blind, placebo-controlled parallel group study Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01424384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK424887 Trade Name: Citalopram Study Indication: Depressive Disorder and Anxiety Disorders

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

- 20/11/2018 - 1 Formulaire, 3 Groupes Item, 19 Eléments de données, 1 Langue

Groupes Item: Administrative data, Liver Biopsy, J. Liver Infections

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 - Liver Biopsy Diagnosis and Liver Architecture

- 20/11/2018 - 1 Formulaire, 4 Groupes Item, 63 Eléments de données, 1 Langue

Groupes Item: Administrative data, Liver Biopsy, A. Final Diagnosis, B. Liver Architecture

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 Simvastatin When Coadministered With Albiglutide NCT01147692 - Liver Biopsy; Liver Events Assessment; Liver Imaging; Liver Event Follow-Up Chemistries

- 29/11/2020 - 1 Formulaire, 10 Groupes Item, 80 Eléments de données, 1 Langue

Groupes Item: Administrative, Liver Biopsy, Liver Events Assessment, Liver Events, Liver Disease Medical Conditions, Drug related Liver Disease Conditions, Other Liver Disease Conditions, Other Medical Conditions, Liver Imaging, Liver event follow-up chemistries

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

Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160 - Liver Biopsy

- 20/09/2021 - 1 Formulaire, 15 Groupes Item, 161 Eléments de données, 1 Langue

Groupes Item: Administrative Data, Date of liver biopsy, Liver biopsy size, Liver Biopsy Final Diagnosis, Liver Architecture, Description of Hepatocytes, Hepatocyte Inclusions or Vacuoles, Hepatocyte Nuclear Abnormalities, Liver or Lobular Infiltrates, Portal Tract Inflammation, Bile Ducts, Portal Veins, Liver Infections, Parasites or ova in liver biopsy, Histologic Staining of Liver Biopsy or Additional Studies Obtained

Study ID: 111364 Clinical Study ID: 111364 Study Title: A 28-Day, Polysomnographic and subjective assessment of Vestipitant (15mg/day) for the treatment of Primary Insomnia in adult Outpatients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00992160 Clinicaltrials.gov Links: https://clinicaltrials.gov/ct2/show/NCT00992160 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Vestipitant, Placebo Trade Name: N/A Study Indication: Primary Insomnia, Sleep Disorders This phase II, placebo-controlled, double-blind trial studies the polysomnographic and subjective effect of the neurokinin (NK1) antagonist vestipitant (15mg/day at bedtime) for the treatment of primary insomnia in adult outpatients over a period of four weeks. The study consists of a clinical Screening Visit (Visit 1), up to 21 days before investigational product/placebo initiation, two screening polysomnographies (Visits 2 and 3), followed by a placebo run-in until Visit 4, at which the subject is randomized to vestipitant or placebo, taken every night for 28 days. On Day 1 and 2 (Visits 4 and 5), polysomnographies are performed. Visit 6 is a safety visit on Day 15. On Day 27 and 28, Visits 7 and 8 are performed, which again include polysomnography studies. Subjects then undergo a 7 to 10 day placebo run-out period and have Day 7 and Day 14 Follow-Up Visit (Visits 9 and 10). This form is to be filled in if a liver biopsy is performed because of an Adverse Liver Event. There are seperate forms for general information on the liver event and for liver imaging (if performed).

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