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Pharmacokinetics of a new unmarketed formulation of ropinirole Follow-up 101468/199 - Follow-up

- 10/27/17 - 1 form, 10 itemgroups, 92 items, 1 language
Itemgroups: Pregnancy test, Physical examination, 12-lead ECG, Vital signs, Laboratory Result Data Haematology, Laboratory Result Data Clinical Chemistry, Urinalysis, Dipstick Test, Status of Treatment Blind, Investigational Product Discontinuation - Ropinirole, Concomitant Medications
Study ID: 101468/199 Clinical Study ID: 101468/199 Study Title: An open label study conducted in healthy volunteers to characterize the pharmacokinetics of a new unmarketed formulation of ropinirole 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 Documentation part (Visit Description): Follow-up

Effects of Esomeprazole on Lapatinib in Subjects with Breast Cancer; 109275 - Follow-up

- 6/25/20 - 1 form, 10 itemgroups, 187 items, 1 language
Itemgroups: Date of visit, Vital signs, 12 lead ECG, 12 lead ECG, Abnormality, Experimental drug, Continuation status, Laboratory Procedures, Chemistry, Clinical, Laboratory Procedures, Hematology finding, Conclusion, Clinical Research, Cessation of life, Pregnancy, Information
Study ID: 109275 Clinical Study ID: 109275 Study Title: An Open-Label, Single Sequence Study to Examine the Effects of Esomeprazole on the Pharmacokinetics of Orally Administered Lapatinib in Subjects with Metastatic ErbB2 Positive Breast Cancer 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: Lapatinib, Esomeprazole Trade Name: lapatinib plus esomeprazole Study Indication: Neoplasms, Breast

Effect of GSK958108 on ejaculatory latency time (ELT); NCT00861484 - Follow-up

- 6/6/20 - 1 form, 14 itemgroups, 167 items, 1 language
Itemgroups: Date of visit, Vital signs, 12 lead ECG, Laboratory Procedures, Hematology finding, Laboratory Procedures, Chemistry, Clinical, Laboratory Procedures, Urinalysis, Laboratory Procedures, Hormones, Laboratory Procedures, Free Testosterone Measurement, Laboratory Procedures, Prolactin measurement, Nervous system structure, Evaluation, Ophthalmic examination and evaluation, Blinded Clinical Study, Status, Pregnancy, Information, Conclusion, Clinical Research
Study ID: 111155 Clinical Study ID: 111155 Study Title: A double blind, parallel group, placebo controlled study to evaluate the effect of a single oral dose of GSK958108 on ejaculatory latency time (ELT) in male patients suffering from premature ejaculation. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00861484 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK958108 , Placebo Trade Name: N/A Study Indication: Premature Ejaculation

Potential Pharmacokinetic Interaction between Lamotrigine and Risperidone; 101963 - Follow-Up

- 4/22/19 - 1 form, 7 itemgroups, 30 items, 1 language
Itemgroups: Administrative documentation, Pregnancy Tests, Vital Signs, Chemistry, Clinical, Hematologic tests, Urinalysis, 12 lead ECG, 12 lead ECG, Abnormality
Study ID: 101963 Clinical Study ID: SCA101963 Study Title: A randomised, blinded, parallel group study to investigate the potential pharmacokinetic interaction between lamotrigine and risperidone in healthy, non-smoking, male 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: lamotrigine Trade Name: Lamictal XR,Lamictal,LAMICTIN Study Indication: Schizophrenia

Bioavailability of an investigational drug compared to Coreg IR in healthy adults GSK104257 - Follow-up

- 4/16/18 - 1 form, 3 itemgroups, 27 items, 1 language
Itemgroups: Vital signs, 12-lead ECG, Lab Data
Study ID: 104257 Clinical Study ID: CRV104257 Study Title: A randomized, open-label, two period, period balanced, crossover study to estimate the relative bioavailability of an investigational drug compared to Coreg IR in healthy adult 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: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension Documentation part: Follow-up

GSK Dose proportionality of fluticasone furoate and equivalence of vilanterol in healthy adults NCT01213849 - Follow-up

- 4/5/18 - 1 form, 5 itemgroups, 33 items, 1 language
Itemgroups: Study Conclusion, Lab Data, Vital Signs, 12-lead ECG, Pregnancy
Study ID: 102932 Clinical Study ID: HZA102932 Study Title:An open-label, randomised, 3-way crossover single dose study to demonstrate dose proportionality of fluticasone furoate (FF) and equivalence of vilanterol (VI) when administered as FF/VI inhalation powder from the novel dry powder inhaler in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01213849 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 Documentation part: Follow-up

GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/188 - Week 28

- 11/6/17 - 1 form, 7 itemgroups, 29 items, 1 language
Itemgroups: Vital signs, Healthcare resource utilisation - Visits/Contacts with Physicians, Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners, Healthcare resource utilisation - Hospitalisation, Healthcare resource utilisation - accident & emergency / emergency room visits, Patient Rated Scales, Ramos Randomisation and Dispensing
Study ID: 101468/188 Clinical Study ID: SKF-101468/188 Study Title:A Study of the Maintained Efficacy and Safety of Ropinirole Versus Placebo in the Long Term Treatment of Restless Legs Syndrome (RLS) 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: ropinirole Trade Name: Requip Study Indication: Parkinson Disease Module: Week 28

GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/188 - Week 12

- 11/6/17 - 1 form, 6 itemgroups, 27 items, 1 language
Itemgroups: Vital signs, Healthcare resource utilisation - Visits/Contacts with Physicians, Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners, Healthcare resource utilisation - Hospitalisation, Healthcare resource utilisation - accident & emergency / emergency room visits, Patient Rated Scales
Study ID: 101468/188 Clinical Study ID: SKF-101468/188 Study Title:A Study of the Maintained Efficacy and Safety of Ropinirole Versus Placebo in the Long Term Treatment of Restless Legs Syndrome (RLS) 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: ropinirole Trade Name: Requip Study Indication: Parkinson Disease Module: Week 12

GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/188 - Concomitant Medication

- 11/6/17 - 1 form, 1 itemgroup, 7 items, 1 language
Itemgroup: Concomitant Medication
Study ID: 101468/188 Clinical Study ID: SKF-101468/188 Study Title:A Study of the Maintained Efficacy and Safety of Ropinirole Versus Placebo in the Long Term Treatment of Restless Legs Syndrome (RLS) 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: ropinirole Trade Name: Requip Study Indication: Parkinson Disease Module: Concomitant Medication (Follow-Up)

GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/188 - Mandatory 7 Day Follow Up Assessment

- 11/6/17 - 1 form, 2 itemgroups, 6 items, 1 language
Itemgroups: Vital signs, Laboratory Evaluation
Study ID: 101468/188 Clinical Study ID: SKF-101468/188 Study Title:A Study of the Maintained Efficacy and Safety of Ropinirole Versus Placebo in the Long Term Treatment of Restless Legs Syndrome (RLS) 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: ropinirole Trade Name: Requip Study Indication: Parkinson Disease Module: Mandatory 7 Day Follow Up Assessment

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