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Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS), 101468/192 - Checklist (Concomitant Medication, Medical Procedure, RLS Rating, Adverse Experiences, CGI Rating and Exclusion criterion)

- 12/03/19 - 1 modulo, 7 itemgroups, 11 elementi, 1 linguaggio
Itemgroups: Administrative data, Concomitant Medication, Medical Procedure, RLS Rating Scales, Adverse Experiences, Clinical Global Impression, Exclusion Criterion
Study ID: 101468/192 Clinical Study ID: 101468/192 Study Title:A 52 Week Open-Label Extension Study of the Long-Term Safety of Ropinirole in Subjects Suffering from 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: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Restless Legs Syndrome The study consists of 16 visits which are devided in 3 study books: Book 1: Screening (+Baseline), Day 2, Week 1, Week 2 , Week 3 , Week 4, Week 5, Week 6, Week 7, Week 8 Book 2: Week 12, Week 24, Week 36, Week 48, Week 52, Follow-up Book 3: Early withdrawal and Follow-up Each follow-up Visit takes place 7 +/- 3 days after last dose This document contains the checklist (Concomitant Medication, Medical Procedure, RLS Rating, Adverse Experiences, CGI Rating and Exclusion criterion) form. Exclusion criterion has to be filled in only for baseline. RLS Rating and CGI Rating have to be checked for each visit. Medical procedure, concomitant medication and adverse experience have to be checked for: Screening/Baseline, Day 2, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 52, Early withdrawal and Follow-up

Pre-dose Checklist Week 5 PK Visit (Visit 9) Ropinirole Parkinson Disease 101468/165 - Pre-dose Checklist Week 5 PK Visit (Visit 9)

- 23/10/17 - 1 modulo, 1 ItemGroup, 10 elementi, 1 linguaggio
ItemGroup: Pre-dose Checklist
Study Part: Pre-dose Checklist Week 5 PK Visit (Visit 9). An open-label, up-titration study to assess the dose proportionality of ropinirole controlled release (CR) and to demonstrate the bioequivalence of ropinirole CR (1 x 8 mg) compared to the ropinirole CR (4 x 2 mg) in Parkinson's Disease patients not receiving other dopaminergic therapies. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Phase: phase 2. Study Recruitment Status: Completed. Generic Name: ropinirole. Trade Name: Modutab, ZIPEREVE, ZEPREVE, REPREVE, ADARTREL, REQUIP,Zygara. Study Indication: Parkinson Disease. Study ID: 101468/165. Clinical Study ID: 101468/165

Pre-dose Checklist Week 3 PK Visit (Visit 8) Ropinirole Parkinson Disease 101468/165 - Pre-dose Checklist Week 3 PK Visit (Visit 8)

- 17/10/17 - 1 modulo, 1 ItemGroup, 10 elementi, 1 linguaggio
ItemGroup: Pre-dose Checklist
Study Part: Pre-dose Checklist Week 3 PK Visit (Visit 8). An open-label, up-titration study to assess the dose proportionality of ropinirole controlled release (CR) and to demonstrate the bioequivalence of ropinirole CR (1 x 8 mg) compared to the ropinirole CR (4 x 2 mg) in Parkinson's Disease patients not receiving other dopaminergic therapies. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Phase: phase 2. Study Recruitment Status: Completed. Generic Name: ropinirole. Trade Name: Modutab, ZIPEREVE, ZEPREVE, REPREVE, ADARTREL, REQUIP,Zygara. Study Indication: Parkinson Disease. Study ID: 101468/165. Clinical Study ID: 101468/165

Pre-dose Checklist Week 2 PK Visit (Visit 6) Ropinirole Parkinson Disease 101468/165 - Pre-dose Checklist Week 2 PK Visit (Visit 6)

- 16/10/17 - 1 modulo, 1 ItemGroup, 10 elementi, 1 linguaggio
ItemGroup: Pre-dose Checklist
Study Part: Pre-dose Checklist Week 2 PK Visit (Visit 6). An open-label, up-titration study to assess the dose proportionality of ropinirole controlled release (CR) and to demonstrate the bioequivalence of ropinirole CR (1 x 8 mg) compared to the ropinirole CR (4 x 2 mg) in Parkinson's Disease patients not receiving other dopaminergic therapies. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Phase: phase 2. Study Recruitment Status: Completed. Generic Name: ropinirole. Trade Name: Modutab, ZIPEREVE, ZEPREVE, REPREVE, ADARTREL, REQUIP,Zygara. Study Indication: Parkinson Disease. Study ID: 101468/165. Clinical Study ID: 101468/165

Pre-dose Checklist Week 1 PK Visit (Visit 3) Ropinirole Parkinson Disease 101468/165 - Pre-dose Checklist Week 1 PK Visit (Visit 3)

- 16/10/17 - 1 modulo, 1 ItemGroup, 10 elementi, 1 linguaggio
ItemGroup: Pre-dose Checklist
Study Part: Pre-dose Checklist Week 1 PK Visit (Visit 3). An open-label, up-titration study to assess the dose proportionality of ropinirole controlled release (CR) and to demonstrate the bioequivalence of ropinirole CR (1 x 8 mg) compared to the ropinirole CR (4 x 2 mg) in Parkinson's Disease patients not receiving other dopaminergic therapies. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Phase: phase 2. Study Recruitment Status: Completed. Generic Name: ropinirole. Trade Name: Modutab, ZIPEREVE, ZEPREVE, REPREVE, ADARTREL, REQUIP,Zygara. Study Indication: Parkinson Disease. Study ID: 101468/165. Clinical Study ID: 101468/165

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Serious Adverse Event (SAE), Investigator's Statement

- 26/07/17 - 1 modulo, 2 itemgroups, 32 elementi, 1 linguaggio
Itemgroups: Serious Adverse Event, investigators checklist
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: Serious Adverse Event, Investigator's Statement

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