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Pregnancy test GSK study Dyskinesia in Parkinson's disease NCT00363727

- 9/7/17 - 1 form, 2 itemgroups, 4 items, 1 language
Itemgroups: General information, Pregnancy test
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: Pregnancy test.

Laboratory tests GSK study Dyskinesia in Parkinson's disease NCT00363727

- 9/7/17 - 1 form, 2 itemgroups, 4 items, 1 language
Itemgroups: General information, Central Laboratory Blood and urine
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: Laboratory tests.

PGx-Pharamacogenetic research GSK study Dyskinesia in Parkinson's disease NCT00363727 - PGx-Pharamacogenetic research study Dyskinesia in Parkinson's disease NCT00363727

- 9/8/17 - 1 form, 5 itemgroups, 12 items, 1 language
Itemgroups: General information, Consent PGx-Pharamacogenetic research, Blood sample collection (DNA), Withdrawal of consent, Blood sample destruction
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: PGx-Pharamacogenetic research.

Follow-up - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

- 10/10/17 - 1 form, 18 itemgroups, 72 items, 1 language
Itemgroups: Concomitant medication, Adverse event, Patient diary, 12-lead electrocardiogram report, orthostatic blood pressure / Pulse, Pregnancy test, Physical examination, Hematology Laboratory evaluation, Hematology Laboratory evaluation, Serum Laboratory evaluation, Serum laboratory evaluation, Urinalysis, Dip stick analysis, Microscopic analysis, Overall urinalysis assessment, Study Completion Part A, Study Completion Part B, Investigator signature
Follow-up - 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

Laboratory Collections Screening Ropinirole Parkinson Disease 101468/165 - Laboratory Collections Screening

- 9/20/21 - 1 form, 1 itemgroup, 5 items, 1 language
Itemgroup: clinical chemistry; haematology
Study Part: Laboratory Collections 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

Urinalysis Test Results Screening Ropinirole Parkinson Disease 101468/165 - Urinalysis Test Results Screening

- 9/20/21 - 1 form, 2 itemgroups, 21 items, 1 language
Itemgroups: URINALYSIS TEST RESULTS, Dip stick
Study Part: Urinalysis Test Results 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

Random Drug Screening (Urine) Week 1 Pre-dose (Visit 1) Ropinirole Parkinson Disease 101468/165 - Random Drug Screening (Urine) Week 1 Pre-dose (Visit 1)

- 9/20/21 - 1 form, 1 itemgroup, 7 items, 1 language
Itemgroup: DRUG SCREENING (URINE)
Study Part: Random Drug Screening (Urine) 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

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

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

Random Drug Screening (Urine) Week 1 PK Visit (Visit 3) Ropinirole Parkinson Disease 101468/165 - Random Drug Screening (Urine) Week 1 PK Visit (Visit 3)

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

Hepatitis B Surface Antigen, Hepatitis C Antibodies And HIV I/ II Antibodies Screening Ropinirole Parkinson Disease 101468/165 - Hepatitis B Surface Antigen, Hepatitis C Antibodies And HIV I/ II Antibodies Screening

- 9/20/21 - 1 form, 1 itemgroup, 7 items, 1 language
Itemgroup: Hepatitis B Surface Antigen; Hepatitis C Antibodies; HIV Antibodies
Study Part: Hepatitis B Surface Antigen, Hepatitis C Antibodies And HIV I/ II Antibodies 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

visit week 36 Pharmacokinetics - Blood Ropinirole CR Ropinirole IR Monotherapy 101468/168

- 10/17/17 - 1 form, 3 itemgroups, 16 items, 1 language
Itemgroups: Administrative data, Pharmacokinetics blood AM visit, Pharmacokinetics Blood PM visit
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

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