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

Pharmacokinetics Liver GSK study Chronic Coronary Heart Disease NCT00799903

- 11/1/18 - 1 Formulaire, 1 Groupe Item, 6 Eléments de données, 1 Langue

Groupe Item: Pharmacokinetics Liver

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: Pharmacokinetics (Liver PK)

Pharmacokinetics GSK study Chronic Coronary Heart Disease NCT00799903

- 3/1/18 - 1 Formulaire, 1 Groupe Item, 6 Eléments de données, 1 Langue

Groupe Item: PK blood sample

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: Pharmacokinetics - Repeating form (Scheduled visits)

PART A - Period 2 - Day 4 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

- 3/10/17 - 1 Formulaire, 11 Groupes Item, 49 Eléments de données, 1 Langue

Groupes Item: orthostatic blood pressure / Pulse - Predose, Concomitant medication, Adverse event, Patient diary, Standard Breakfast, Pharmacokinetics, Study Drug Dosing, Study Drug Dosing - Lunch, Study Drug Dosing - Dinner, Pharmacokinetic sampling post dosing (CR), Pharmacokinetic sampling post dosing (IR)

PART A - Period 2 - Day 4 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164 Study ID: 101468/164 Clinical Study ID: 101468/164 Study Title: An open-label, randomised, two part study to investigate the relative bioavailability of Ropinirole new and standard, marketed formulations and the effect of food on the pharmacokinetics of Ropinirole new formulation in early stage Parkinson’s disease subjects 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: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome

PART A - Period 1 - PK Sampling Day - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

- 3/10/17 - 1 Formulaire, 11 Groupes Item, 49 Eléments de données, 1 Langue

Groupes Item: orthostatic blood pressure / Pulse - Predose, Concomitant medication, Adverse event, Patient diary, Standard Breakfast, Pharmacokinetics, Study Drug Dosing, Study Drug Dosing - Lunch, Study Drug Dosing - Dinner, Pharmacokinetic sampling post dosing (CR), Pharmacokinetic sampling post dosing (IR)

PART A - Period 1 - PK Sampling Day - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164 Study ID: 101468/164 Clinical Study ID: 101468/164 Study Title: An open-label, randomised, two part study to investigate the relative bioavailability of Ropinirole new and standard, marketed formulations and the effect of food on the pharmacokinetics of Ropinirole new formulation in early stage Parkinson’s disease subjects 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: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome

PART A - Period 2 - Day 2 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

- 3/10/17 - 1 Formulaire, 8 Groupes Item, 27 Eléments de données, 1 Langue

Groupes Item: orthostatic blood pressure / Pulse - Predose, Concomitant medication, Adverse event, Patient diary, Standard Breakfast, Pharmacokinetics, Study Drug Dosing, Discharge

PART A - Period 2 - Day 2 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164 Study ID: 101468/164 Clinical Study ID: 101468/164 Study Title: An open-label, randomised, two part study to investigate the relative bioavailability of Ropinirole new and standard, marketed formulations and the effect of food on the pharmacokinetics of Ropinirole new formulation in early stage Parkinson’s disease subjects 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: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome

GSK Ropinirole in Patients Suffering from Parkinsons Disease Week 12 101468/169 NCT00381472

- 17/9/17 - 1 Formulaire, 21 Groupes Item, 65 Eléments de données, 1 Langue

Groupes Item: DIARY INFORMATION, General Information, SUBJECT CONTINUATION, ADVERSE EVENTS PROMPT, CONCOMITANT MEDICATION PROMPT, L-DOPA MEDICATION CHANGES, VITAL SIGNS, SUBJECT’S FOOD INTAKE DAY BEFORE PK SAMPLING, SUBJECT’S FOOD INTAKE ON THE DAY OF PK SAMPLING, PHARMACOKINETICS - BLOOD, CLINICAL GLOBAL IMPRESSION, UNIFIED PARKINSONS DISEASE RATING SCALE, PARKINSON’S DISEASE SLEEP SCALE, BECK DEPRESSION INVENTORY, EPWORTH SLEEPINESS SCALE, PARKINSON’S DISEASE QUALITY OF LIFE QUESTIONNAIRE (PDQ-39), INVESTIGATIONAL PRODUCT, COMPLIANCE, DISPENSING, DIARY CARD, CONTINUATION

Study ID: 101468/169 Clinical Study ID: 101468/169 Study Title:A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment with Ropinirole CR as Adjunctive Therapy in Patients with Parkinson's Disease who are not Optimally Controlled on L-dopa Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00381472 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Parkinson Disease This is the Week 12 form.

GSK Ropinirole in Patients Suffering from Parkinsons Disease Week 16 101468/169 NCT00381472

- 17/9/17 - 1 Formulaire, 16 Groupes Item, 57 Eléments de données, 1 Langue

Groupes Item: DIARY INFORMATION, General Information, SUBJECT CONTINUATION, ADVERSE EVENTS PROMPT, CONCOMITANT MEDICATION PROMPT, L-DOPA MEDICATION CHANGES, VITAL SIGNS, SUBJECT’S FOOD INTAKE DAY BEFORE PK SAMPLING, SUBJECT’S FOOD INTAKE ON THE DAY OF PK SAMPLING, PHARMACOKINETICS - BLOOD, CLINICAL GLOBAL IMPRESSION, INVESTIGATIONAL PRODUCT, COMPLIANCE, DISPENSING, DIARY CARD, CONTINUATION

Study ID: 101468/169 Clinical Study ID: 101468/169 Study Title:A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment with Ropinirole CR as Adjunctive Therapy in Patients with Parkinson's Disease who are not Optimally Controlled on L-dopa Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00381472 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Parkinson Disease This is the Week 16 form.

GSK Ropinirole in Patients Suffering from Parkinsons Disease Week 20 101468/169 NCT00381472

- 17/9/17 - 1 Formulaire, 16 Groupes Item, 57 Eléments de données, 1 Langue

Groupes Item: DIARY INFORMATION, General Information, SUBJECT CONTINUATION, ADVERSE EVENTS PROMPT, CONCOMITANT MEDICATION PROMPT, L-DOPA MEDICATION CHANGES, VITAL SIGNS, SUBJECT’S FOOD INTAKE DAY BEFORE PK SAMPLING, SUBJECT’S FOOD INTAKE ON THE DAY OF PK SAMPLING, PHARMACOKINETICS - BLOOD, CLINICAL GLOBAL IMPRESSION, INVESTIGATIONAL PRODUCT, COMPLIANCE, DISPENSING, DIARY CARD, CONTINUATION

Study ID: 101468/169 Clinical Study ID: 101468/169 Study Title:A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment with Ropinirole CR as Adjunctive Therapy in Patients with Parkinson's Disease who are not Optimally Controlled on L-dopa Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00381472 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Parkinson Disease This is the Week 20 form.

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Treatment Period 2 Dosing Details 13-17, PK Sampling 3-5

- 30/7/17 - 1 Formulaire, 8 Groupes Item, 30 Eléments de données, 1 Langue

Groupes Item: dosing details, pk sampling, dosing details, dosing details, dosing details, dosing details, pk sampling, pk sampling

Study ID: 100716 Clinical Study ID: NKP100716 Study Title: An open label repeat dose study to investigate the effect of GW597599 (15 mg) and paroxetine (10 mg) given in combination for 15 days on the pharmacokinetics of midazolam and dextromethorphan in healthy male and female 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: vestipitant Trade Name: paroxetine and vestipitant Study Indication: Depressive Disorder and Anxiety Disorders Documentation part: Treatment Period 2 Dosing Details 13-17, PK Sampling 3-5

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Treatment Period 2 Laboratory Collections 5, Dosing Details 11-12, PK Sampling 1-2

- 30/7/17 - 1 Formulaire, 4 Groupes Item, 14 Eléments de données, 1 Langue

Groupes Item: clinical chemistry and hematology, urinanalysis, dosing details, pk sampling

Study ID: 100716 Clinical Study ID: NKP100716 Study Title: An open label repeat dose study to investigate the effect of GW597599 (15 mg) and paroxetine (10 mg) given in combination for 15 days on the pharmacokinetics of midazolam and dextromethorphan in healthy male and female 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: vestipitant Trade Name: paroxetine and vestipitant Study Indication: Depressive Disorder and Anxiety Disorders Documentation part: Treatment Period 2 Laboratory Collections 5, Dosing Details 11-12, PK Sampling 1-2

Pharmacokinetics- Blood Week 38 Mepolizumab HES NCT00086658 - Pharmacokinetics- Blood Week 38

- 15/7/17 - 1 Formulaire, 1 Groupe Item, 4 Eléments de données, 1 Langue

Groupe Item: Pharmacokinetics Blood

Study part: Pharmacokinetics- Blood Week 38/ Early Withdrawal visit.A Phase 2 Multicenter, Double-blind, Placebo-controlled, Study to to Evaluate the Corticosteroid- sparing effects of Mepolizumab in Subjects with Hypereosinophilic Syndromes (HES) and Evaluate Efficacy and Safety of Mepolizumab in Controlling the Clinical Signs and Symptoms of subjects with HES Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Study ID: 100185, Clinical Study ID:MHE100185.

Pharmacokinetics- Blood Week 32 Mepolizumab HES NCT00086658 - Pharmacokinetics- Blood Week 32

- 12/7/17 - 1 Formulaire, 1 Groupe Item, 5 Eléments de données, 1 Langue