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  1. 1. Clinical Trial
  2. 2. Routine Documentation
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Efficacy and Safety of Ropinirole XR (Extended Release) in Patients with Restless Legs Syndrome NCT00197080 - Week 10 - Vital Signs Pre-Dose; Subject's Food Intake; Investigational Product; Vital Signs - Post-Dose

- 2/18/19 - 1 form, 6 itemgroups, 23 items, 1 language
Itemgroups: Administrative, Vital Signs - Pre-Dose, Subject's Food Intake, Investigational Product, Vital Signs - 2 Hours Post-Dose, Vital Signs - 4 Hours Post-Dose
Study ID: 101468/205 Clinical Study ID: 101468/205 Study Title:A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole XR (Extended Release) in Patients with Restless Legs Syndrome Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00197080 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 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

Efficacy and Safety of Ropinirole XR (Extended Release) in Patients with Restless Legs Syndrome NCT00197080 - Baseline - Vital Signs Pre-Dose; Subject's Food Intake; 12-Lead-ECG - Pre-Dose; Randomisation Number; Investigational Product; Vital Signs - Post-Dose

- 2/12/19 - 1 form, 8 itemgroups, 24 items, 1 language
Itemgroups: Administrative, Vital Signs - Pre-Dose, Subject's Food Intake, 12-Lead ECG - Pre-Dose, Randomisation Number, Investigational Product, Vital Signs - 2 Hours Post-Dose, Vital Signs - 4 Hours Post-Dose
Study ID: 101468/205 Clinical Study ID: 101468/205 Study Title:A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole XR (Extended Release) in Patients with Restless Legs Syndrome Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00197080 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 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

Efficacy and Tolerability of TREXIMA Tablets vs. Placebo During Mild Migraine Study ID 101998 - Investigational Product Use/Status of Treatment Blind

- 1/25/19 - 1 form, 3 itemgroups, 7 items, 1 language
Itemgroups: Administrative Data, Investigational Product Use, Status Of Treatment Blind
Study ID: 101998 Clinical Study ID: 101998 Study Title: A randomized, double-blind, parallel group, placebo-controlled, single-attack evaluation of the efficacy and tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg)* tablets vs placebo when administered during the mild pain phase of a migraine Patient Level Data Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier Sponsor GlaxoSmithKline Collaborators N/A Phase Phase 3 Study Recruitment Status Completed Generic Name sumatriptan Trade Name Imitrex ,Imiject ,Imigran Study Indication Migraine Disorders The purpose of this form is to document the subjects intake of the investigational product and the status of treatment blind. It should be filled out at the final visit.

Effect of inhaled fluticasone furoate/Vilanterol combination on electrocardiographic parameters in healthy subjects, NCT01209026 - Randomisation Number, investigational product

- 1/14/19 - 1 form, 4 itemgroups, 13 items, 1 language
Itemgroups: Administrative data, Randomisation Number, Investigational product - Container Number, Investigational product - Day 1-7, treatment confirmation
Study ID: 102936 Clinical Study ID: HZA102936 Study Title:A randomised, placebo-controlled, four-way crossover repeat dose study to evaluate the effect of the inhaled fluticasone furoate (FF)/GW642444M combination on electrocardiographic parameters, with moxifloxacin as a positive control, in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01209026 https://clinicaltrials.gov/ct2/show/NCT01209026?term=NCT01209026 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Allermist,Veramyst,Avamys; Veramyst,Avamys,Allermist Study Indication: Asthma The study consists of a screening, 4 treatment periods and a follow up. Treatment periods 1-4 are each 7 days long. Treatment period 1 Days 1-6 (TP1D-D6) Treatment period 1 Day 7 (TP1D7) Treatment period 2 Days 1-6 (TP2D1-D6) Treatment period 2 Day 7 (TP2D7) Treatment period 3 Days 1-6 (TP3D1-D6) Treatment period 3 Day 7 (TP3D7) Treatment period 4 Days 1-6 (TP4D1-D6) Treatment period 4 Day 7 (TP4D7) This document contains the Randomisation Number form. It has to be filled in for TP1 Day 1. It also contains the investigational product form. It has to be filled in for all treatment periods. Day 1 and 7 have to be filled in by the study investigator. Day 2-6 have to be transcribed from subjects entries.

A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904 - Pregnancy Notification Form

- 1/11/19 - 1 form, 7 itemgroups, 46 items, 1 language
Itemgroups: Administrative data, Pregnancy Notification Form (Subject), Mother's Relevant Medical/Family History, If applicable, record the number in the appropriate categories below:, Father's Relevant Medical/Family History, Drug Exposures, Reporting Investigator Information
Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR 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: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904 - Logs and Repeats: Concomitant Medications

- 1/11/19 - 1 form, 2 itemgroups, 17 items, 1 language
Itemgroups: Administrative data, Concomitant Medications
Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR 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: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904 - Logs and Repeats: Adverse Event

- 1/11/19 - 1 form, 2 itemgroups, 21 items, 1 language
Itemgroups: Administrative data, Adverse Events
Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR 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: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904 - Session 4: Investigational Product

- 1/9/19 - 1 form, 5 itemgroups, 20 items, 1 language
Itemgroups: Administrative data, Investigational Product - Regimen A - 40 mg Carvedilol CR, Investigational Product - 40 mg Carvedilol Regimen B Alcohol Ingestion - 240 ml OF 20%EtOH, Investigational Product - Regimen C Alcohol Ingestion - 240 ml OF 20% EtOH, Investigational Product - Regimen D Alcohol Ingestion - 240 ml OF 20% EtOH
Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR 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: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904 - Session 3: Investigational Product

- 1/9/19 - 1 form, 5 itemgroups, 19 items, 1 language
Itemgroups: Administrative data, Investigational Product - Regimen A - 40 mg Carvedilol CR, Investigational Product - 40 mg Carvedilol Regimen B Alcohol Ingestion - 240 ml OF 20%EtOH, Investigational Product - Regimen C Alcohol Ingestion - 240 ml OF 20% EtOH, Investigational Product - Regimen D Alcohol Ingestion - 240 ml OF 20% EtOH
Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR 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: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

Effect of inhaled fluticasone furoate/Vilanterol combination on electrocardiographic parameters in healthy subjects, NCT01209026 - Meal

- 1/9/19 - 1 form, 3 itemgroups, 9 items, 1 language
Itemgroups: Administrative data, Dosing date and time, Meal
Study ID: 102936 Clinical Study ID: HZA102936 Study Title:A randomised, placebo-controlled, four-way crossover repeat dose study to evaluate the effect of the inhaled fluticasone furoate (FF)/GW642444M combination on electrocardiographic parameters, with moxifloxacin as a positive control, in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01209026 https://clinicaltrials.gov/ct2/show/NCT01209026?term=NCT01209026 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Allermist,Veramyst,Avamys; Veramyst,Avamys,Allermist Study Indication: Asthma The study consists of a screening, 4 treatment periods and a follow up. Treatment periods 1-4 are each 7 days long. Treatment period 1 Days 1-6 (TP1D-D6) Treatment period 1 Day 7 (TP1D7) Treatment period 2 Days 1-6 (TP2D1-D6) Treatment period 2 Day 7 (TP2D7) Treatment period 3 Days 1-6 (TP3D1-D6) Treatment period 3 Day 7 (TP3D7) Treatment period 4 Days 1-6 (TP4D1-D6) Treatment period 4 Day 7 (TP4D7) This document contains the Meal form. It has to be filled in for TP1 D-1, TP1-4 day 7 for each.

Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032 - Period 2 Day 21 + Day 22

- 12/27/18 - 1 form, 13 itemgroups, 69 items, 1 language
Itemgroups: Administrative data, Day 21, Vital Signs - Duplicate 1, Vital Signs - Duplicate 2, Study Drug Administration, Laboratory Test - Urine HCG, Pharmacodynamic Blood Collection, Pharmacokinetic Blood Collection, Day 22, Vital Signs - Duplicate 1, Vital Signs - Duplicate 2, Study Drug Administration, Pharmacokinetic Blood Collection
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 - Period 2 Day 18 + Day 19 + Day 20

- 12/27/18 - 1 form, 21 itemgroups, 112 items, 1 language
Itemgroups: Administrative data, Day 18, Vital Signs - Duplicate 1, Vital Signs - Duplicate 2, Study Drug Administration, Day 19, Vital Signs - Duplicate 1, Vital Signs - Duplicate 2, Study Drug Administration, Study Drug Administration 2 , Pharmacokinetic Blood Collection, Day 20, Vital Signs - Duplicate 1, Vital Signs - Duplicate 2, Electrocardiogram, Overall Interpretation of ECG, Study Drug Administration, Hematologic Test, Chemistry Test, UA/Urine Chemistry, Pharmacokinetic Blood Collection
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

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