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REFLECT-1 Early Withdrawal Follow Up NCT00428090

- 2016-09-25 - 1 Formulär, 10 Item-grupper, 16 Dataelement, 1 Språk
Item-grupper: Patient Information, Central Laboratory Instructions, Investigator Instructions, Vital signs, Central Laboratory, Concomitant Medication, Adverse Event, Physical Examination, Pedal Oedema, End of Study Assessments
NCT00428090 / GSK-AVA105640 A 24-week, double-blind, double-dummy, randomized, parallel-group study to investigate the effects of rosiglitazone (extended release tablets), donepezil, and placebo as monotherapy on cognition and overall clinical response in APOE e4-stratified subjects with mild to moderate Alzheimer’s disease. (REFLECT-1)

REFLECT-1 Study End/ Follow Up NCT00428090

- 2016-09-25 - 1 Formulär, 9 Item-grupper, 16 Dataelement, 1 Språk
Item-grupper: Patient Information, Central Laboratory Instructions, Investigator Instructions, Vital signs, Central Laboratory, Concomitant Medication, Adverse Event, Physical Examination, Pedal Oedema
NCT00428090 / GSK-AVA105640 A 24-week, double-blind, double-dummy, randomized, parallel-group study to investigate the effects of rosiglitazone (extended release tablets), donepezil, and placebo as monotherapy on cognition and overall clinical response in APOE e4-stratified subjects with mild to moderate Alzheimer’s disease. (REFLECT-1)

Follow-Up Ropinirole in Parkinson's Disease GSK 101468/196

- 2017-10-12 - 1 Formulär, 6 Item-grupper, 46 Dataelement, 1 Språk
Item-grupper: Patient Information, Orthostatic Blood Pressure, Compliance, Pregnancy Test, Completion of Dosing Period, Investigator Signature
Study ID: 101468/196 Clinical Study ID: 101468/196 Study Title: 101468/196: A Long-Term, Open-Label Continuation Study of Once Daily Administration of Ropinirole CR Tablets to Patients with Parkinson's Disease who Completed the Previous Ropinirole CR Studies 167 or 164 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00650104 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 : Parkinson DiseaseA Long-Term, Open-Label Continuation Study of Once Daily Adminstration of Ropinirole CR Tablets to Patients with Parkinson's Disease Who Completed the Previous Ropinirole CR Studies - 167 & 164 Follow-Up

Follow-Up GSK Ropinirole Restless Legs Syndrome 101468

- 2017-09-13 - 1 Formulär, 11 Item-grupper, 77 Dataelement, 1 Språk
Item-grupper: Patient Information, Pregnancy Test, Vital Signs, 12 Lead ECG, Clinical Chemistry & Hematology, Drug Screening (Urine), Urinanalysis, Pregnancy, Study Conclusion, Adverse Event, Investigator's Statement
Study ID: 101468/207 Clinical Study ID: SKF-101468/207 Study Title:A double-blind, randomized, placebo-controlled, parallel-group study to investigate the tolerability of a dose-escalating regimen of ropinirole in patients suffering from Restless Legs Syndrome (RLS). 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 : Restless Legs Syndrome Follow-Up

Investigational Product Follow-up Ropinirole NCT00632736 - Investigational Product Follow-up

- 2017-07-30 - 1 Formulär, 1 Item-grupp, 5 Dataelement, 1 Språk
Item-grupp: Investigational Product
Study part: Investigational Product Follow-up.An Open-Label Extension phase 3 Study with REQUIP (ropinirole) CR for Subjects from Studies 101468/165, 101468/168 and 101468/169 Patient Level Data. Study ID:101468/248, Clinical Study ID: 101468/248.

Adverse Events Follow-up Ropinirole NCT00632736 - Adverse Events Follow-up

- 2017-07-30 - 1 Formulär, 1 Item-grupp, 1 Dataelement, 1 Språk
Item-grupp: Adverse Events
Study part: Adverse Events Follow-up. An Open-Label Extension phase 3 Study with REQUIP (ropinirole) CR for Subjects from Studies 101468/165, 101468/168 and 101468/169 Patient Level Data. Study ID:101468/248, Clinical Study ID: 101468/248.

Investigator’s Statement Follow-Up Ropinirole Parkinson Disease 101468/165 - Investigator’s Statement Follow-Up

- 2017-11-20 - 1 Formulär, 1 Item-grupp, 9 Dataelement, 1 Språk
Item-grupp: Investigators Statement
Study Part: Investigator’s Statement Follow-Up. 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

General Comments Follow- Up Ropinirole Parkinson Disease 101468/165 - General Comments Follow- Up

- 2017-11-19 - 1 Formulär, 1 Item-grupp, 2 Dataelement, 1 Språk
Item-grupp: General Comments
Study Part: General Comments Follow- Up. 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 Follow- Up (Visit 10) Ropinirole Parkinson Disease 101468/165 - Vital Signs Follow- Up (Visit 10)

- 2021-09-27 - 1 Formulär, 1 Item-grupp, 10 Dataelement, 1 Språk
Item-grupp: Vital Signs
Study Part: Vital Signs Follow- Up (Visit 10). 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

Laboratory Collections Follow- Up (Visit 10) Ropinirole Parkinson Disease 101468/165 - Laboratory Collections Follow- Up (Visit 10)

- 2021-09-27 - 1 Formulär, 1 Item-grupp, 5 Dataelement, 1 Språk
Item-grupp: clinical chemistry; haematology
Study Part: Laboratory Collections Follow- Up (Visit 10). 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 Follow- Up (Visit 10) Ropinirole Parkinson Disease 101468/165 - Urinalysis Test Results Follow- Up (Visit 10)

- 2021-09-27 - 1 Formulär, 2 Item-grupper, 21 Dataelement, 1 Språk
Item-grupper: URINALYSIS TEST RESULTS, Dip stick
Study Part: Urinalysis Test Results Follow- Up (Visit 10). 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

Study Conclusion Follow- Up (Visit 10) Ropinirole Parkinson Disease 101468/165 - Study Conclusion Follow- Up (Visit 10)

- 2017-11-19 - 1 Formulär, 1 Item-grupp, 9 Dataelement, 1 Språk
Item-grupp: Study Conclusion
Study Part: Study Conclusion Follow- Up (Visit 10). 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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