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Prior Parkinson’s Medication Screening Ropinirole Parkinson Disease 101468/165 - Prior Parkinson’s Medication Screening

- 2021-09-20 - 1 Formulär, 1 Item-grupp, 11 Dataelement, 1 Språk
Item-grupp: Medication Parkinson Disease
Study Part: Prior Parkinson’s Medication 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

Dosing Details Week 2 PK Visit (Visit 6) Ropinirole Parkinson Disease 101468/165 - Dosing Details Week 2 PK Visit (Visit 6)

- 2017-10-17 - 1 Formulär, 1 Item-grupp, 5 Dataelement, 1 Språk
Item-grupp: Dosing
Study Part: Dosing Details 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

Dosing Details Week 1 PK Visit (Visit 3) Ropinirole Parkinson Disease 101468/165 - Dosing Details Week 1 PK Visit (Visit 3)

- 2017-10-16 - 1 Formulär, 1 Item-grupp, 5 Dataelement, 1 Språk
Item-grupp: Dosing
Study Part: Dosing Details 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

Dosing Details Week 1 Day 1 (Visit 2) Ropinirole Parkinson Disease 101468/165 - Dosing Details Week 1 Day 1 (Visit 2)

- 2017-10-16 - 1 Formulär, 1 Item-grupp, 5 Dataelement, 1 Språk
Item-grupp: Dosing
Study Part: Dosing Details Week 1 Day 1 (Visit 2). 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

L-Dopa medication GSK study Dyskinesia in Parkinson's disease NCT00363727

- 2017-09-08 - 1 Formulär, 4 Item-grupper, 14 Dataelement, 1 Språk
Item-grupper: General information, L-Dopa medication changes, L-Dopa medication, Parkinson's disease symptom control
Study ID: 101468/228 Clinical Study ID: 101468/228 Study Title:A two year Phase IIIb randomised, multicenter, double-blind, SINEMET controlled, parallel group, flexible dose study, to assess the effectiveness of controlled release ropinirole add-on therapy to L-dopa at increasing the time to onset of dyskinesia in Parkinson's disease subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00363727 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 : Dyskinesias; Parkinson Disease; Parkinson's Disease Study part: L-Dopa medication

Concomitant medications GSK study Dyskinesia in Parkinson's disease NCT00363727

- 2017-09-08 - 1 Formulär, 2 Item-grupper, 12 Dataelement, 1 Språk
Item-grupper: General information, Concomitant medications
Study ID: 101468/228 Clinical Study ID: 101468/228 Study Title:A two year Phase IIIb randomised, multicenter, double-blind, SINEMET controlled, parallel group, flexible dose study, to assess the effectiveness of controlled release ropinirole add-on therapy to L-dopa at increasing the time to onset of dyskinesia in Parkinson's disease subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00363727 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 : Dyskinesias; Parkinson Disease; Parkinson's Disease Study part: Concomitant medications

status of treatment blind Ropinirole CR Ropinirole IR Monotherapy 101468/168

- 2017-12-06 - 1 Formulär, 2 Item-grupper, 6 Dataelement, 1 Språk
Item-grupper: administrative data, Status of treatment blind
Study ID: 101468/168 Clinical Study ID: 101468/168 Study Title: A Randomised, Double Blind, Three Period, Cross-Over Study of Ropinirole CR and Ropinirole IR Monotherapy 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 Study Indication: Parkinson Disease

Randomization/Drug dispensing GSK study Dyskinesia in Parkinson's disease NCT00363727 - Randomization/Drug dispensing study Dyskinesia in Parkinson's disease NCT00363727

- 2017-09-08 - 1 Formulär, 4 Item-grupper, 8 Dataelement, 1 Språk
Item-grupper: General information, Total Daily L-Dopa Dosing, Randomization number, Drug dispensing
Study ID: 101468/228 Clinical Study ID: 101468/228 Study Title:A two year Phase IIIb randomised, multicenter, double-blind, SINEMET controlled, parallel group, flexible dose study, to assess the effectiveness of controlled release ropinirole add-on therapy to L-dopa at increasing the time to onset of dyskinesia in Parkinson's disease subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00363727 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 : Dyskinesias; Parkinson Disease; Parkinson's Disease. Study part: Randomization/Drug dispensing

Investigational Product GSK study Dyskinesia in Parkinson's disease NCT00363727 - Investigational Product study Dyskinesia in Parkinson's disease NCT00363727

- 2017-09-08 - 1 Formulär, 3 Item-grupper, 12 Dataelement, 1 Språk
Item-grupper: General information, Investigational product, Compliance
Study ID: 101468/228 Clinical Study ID: 101468/228 Study Title:A two year Phase IIIb randomised, multicenter, double-blind, SINEMET controlled, parallel group, flexible dose study, to assess the effectiveness of controlled release ropinirole add-on therapy to L-dopa at increasing the time to onset of dyskinesia in Parkinson's disease subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00363727 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 : Dyskinesias; Parkinson Disease; Parkinson's Disease Study part: Investigational Product.

Status of treatment blind GSK study Dyskinesia in Parkinson's disease NCT00363727

- 2017-09-08 - 1 Formulär, 2 Item-grupper, 7 Dataelement, 1 Språk
Item-grupper: General information, Status of treatment blind
Study ID: 101468/228 Clinical Study ID: 101468/228 Study Title:A two year Phase IIIb randomised, multicenter, double-blind, SINEMET controlled, parallel group, flexible dose study, to assess the effectiveness of controlled release ropinirole add-on therapy to L-dopa at increasing the time to onset of dyskinesia in Parkinson's disease subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00363727 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 : Dyskinesias; Parkinson Disease; Parkinson's Disease Study part: Status of treatment blind.

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