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  1. 1. Clinical Trial
  2. 2. Routine Documentation
  3. 3. Registry/Cohort Study
  4. 4. Quality Assurance
  5. 5. Data Standard
  6. 6. Patient-Reported Outcome
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Demography Screening Ropinirole Parkinson Disease 101468/165 - Demography Screening

- 10/15/17 - 1 form, 1 itemgroup, 10 items, 1 language
Itemgroup: Demography
Study Part: Demography Screening. 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

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

- 9/20/21 - 1 form, 18 itemgroups, 90 items, 1 language
Itemgroups: Note,Inclusion Criteria,Exclusion Criteria,Physical examination,Pregnancy test,Alcohol test,Urine drug screening,orthostatic blood pressure / Pulse - Predose,Concomitant medication,Adverse event,Patient diary,Randomization,High fat breakfast,Study Drug Dosing,Orthostatic blood pressure / pulse measurement - post dose,Adverse Event - post dosing,Pharmacokinetic sampling post dosing,Discharge
PART B - Period 1 - Day 1 - 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

visit 1 inclusion/exclusion criteria starting dose of ropinirole Parkinson's Disease 101468/166

- 9/20/21 - 1 form, 3 itemgroups, 28 items, 1 language
Itemgroups: administrative data,Inclusion criteria,exclusion criteria
Study ID: 101468/166 Clinical Study ID: SKF-101468/166 Study Title: A Phase II, randomised, double-blind, active-controlled, dose-escalation study to determine the maximum well-tolerated starting dose of a new formulation of ropinirole in Parkinson's Disease patients not receiving other dopaminergic therapies Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Parkinson Disease

Eligibility Parkinson's Disease NCT00360412

- 9/20/21 - 1 form, 2 itemgroups, 16 items, 1 language
Itemgroups: Inclusion Criteria,Exclusion Criteria
A Study of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations; ODM derived from: https://clinicaltrials.gov/show/NCT00360412

Eligibility Parkinson's Disease NCT00292227

- 9/20/21 - 1 form, 2 itemgroups, 21 items, 1 language
Itemgroups: Inclusion Criteria,Exclusion Criteria
Cardiac Effects of Rotigotine Transdermal System in Subjects With Advanced-stage Idiopathic Parkinson's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00292227

Vital Signs Week 3 (Visit 7) Ropinirole Parkinson Disease 101468/165 - Vital Signs Week 3 (Visit 7)

- 9/20/21 - 1 form, 1 itemgroup, 10 items, 1 language
Itemgroup: Vital Signs
Study Part: Vital Signs Week 3 (Visit 7). 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

Random Drug Screening (Urine) Week 4 PK Visit (Visit 8) Ropinirole Parkinson Disease 101468/165 - Random Drug Screening (Urine) Week 4 PK Visit (Visit 8)

- 9/20/21 - 1 form, 1 itemgroup, 8 items, 1 language
Itemgroup: DRUG SCREENING (URINE)
Study Part: Random Drug Screening (Urine) Week 4 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

Vital Signs Week 2 PK Visit (Visit 6) Ropinirole Parkinson Disease 101468/165 - Vital Signs Week 2 PK Visit (Visit 6)

- 9/20/21 - 1 form, 1 itemgroup, 11 items, 1 language
Itemgroup: Vital Signs
Study Part: Vital Signs 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

Random Drug Screening (Urine) Week 2 PK Visit (Visit 6) Ropinirole Parkinson Disease 101468/165 - Random Drug Screening (Urine) Week 2 PK Visit (Visit 6)

- 9/20/21 - 1 form, 1 itemgroup, 8 items, 1 language
Itemgroup: DRUG SCREENING (URINE)
Study Part: Random Drug Screening (Urine) 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

Vital Signs Week 1 PK Visit (Visit 3) Ropinirole Parkinson Disease 101468/165 - Vital Signs Week 1 PK Visit (Visit 3)

- 9/20/21 - 1 form, 1 itemgroup, 11 items, 1 language
Itemgroup: Vital Signs
Study Part: Vital Signs 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

Vital Signs Screening Ropinirole Parkinson Disease 101468/165 - Vital Signs Screening

- 9/20/21 - 1 form, 1 itemgroup, 10 items, 1 language
Itemgroup: Vital Signs
Study Part: Vital Signs Screening. 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

Vital Signs Week 1 Pre-dose (Visit 1)Ropinirole Parkinson Disease 101468/165 - Vital Signs Week 1 Pre-dose (Visit 1)

- 9/20/21 - 1 form, 1 itemgroup, 11 items, 1 language
Itemgroup: Vital Signs
Study Part: Vital Signs Week 1 Pre-dose (Visit 1). 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

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