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Relevancia Evaluación Nuevo primero Antiguo primero

Dyskinesias GSK study Dyskinesia in Parkinson's disease NCT00363727

- 8/9/17 - 1 formulario, 2 itemgroups, 7 items, 1 idioma
Itemgroups: General information, Dyskinesia
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: Dyskinesias.

Vital Signs GSK study Dyskinesia in Parkinson's disease NCT00363727

- 7/9/17 - 1 formulario, 4 itemgroups, 11 items, 1 idioma
Itemgroups: General information, Height and Weight, Vital signs Semi-supine, Vital signs Standing
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: Vital signs.

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

- 10/10/17 - 1 formulario, 18 itemgroups, 72 items, 1 idioma
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

Screening Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148

- 20/9/21 - 1 formulario, 27 itemgroups, 251 items, 1 idioma
Itemgroups: Subject Information, Demography, Child-bearing Potential (Complete for Female Subjects Only), Pregnancy Test (Complete for Female Subjects of Child-bearing Potential Only), Local Laboratory Result Data, Medical Conditions, Urine Drug Screen, Alcohol Test, Serology - HIV/Hepatitis Screen, Physical examination, History of tobacco use, Vital signs, 12-Lead ECG, 12-Lead ECG Abnormalities, 12-Lead ECG Abnormalities: A. Rhythm, 12-Lead ECG Abnormalities: B. P-Wave and QRS Morphology, 12-Lead ECG Abnormalities: C. Conduction, 12-Lead ECG Abnormalities: D. Myocardial Infarction, 12-Lead ECG Abnormalities: E. Depolarisation/Repolarisation (QRS-T), 12-Lead ECG Abnormalities: Other Abnormalities, Local laboratory result data (haematology), Local laboratory result data - (clinical chemistry), Urinalysis, Eligibility Question, Inclusion Criteria, Exclusion Criteria, Investigator Comment Log
Documentation Part: Screening An Open Label, Repeat Dose, Dose Escalation Study Conducted in Parkinson's Disease Patients to Characterize the Pharmacokinetics and Effect of Food on Ropinirole Prolonged Release (PR/CR) 12mg Tablets. ClinicalTrials.gov Identifier: NCT00460148 https://clinicaltrials.gov/ct2/show/NCT00460148?term=NCT00460148&rank=1 Responsible Party: GlaxoSmithKline

Treatment Phase Day 22 Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148

- 10/4/17 - 1 formulario, 7 itemgroups, 27 items, 1 idioma
Itemgroups: Subject information, Visit date, Vital signs, 12-Lead-ECG, Invesatigational product, Treatment confirmation, Ambulatory blood pressure monitoring
Documentation Part: Treatment Phase Day 22 An Open Label, Repeat Dose, Dose Escalation Study Conducted in Parkinson's Disease Patients to Characterize the Pharmacokinetics and Effect of Food on Ropinirole Prolonged Release (PR/CR) 12mg Tablets. ClinicalTrials.gov Identifier: NCT00460148 https://clinicaltrials.gov/ct2/show/NCT00460148?term=NCT00460148&rank=1 Responsible Party: GlaxoSmithKline

Treatment Phase Day 29 Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148

- 11/4/17 - 1 formulario, 7 itemgroups, 27 items, 1 idioma
Itemgroups: Subject information, Visit date, Vital signs, 12-Lead-ECG, Invesatigational product, Treatment confirmation, Ambulatory blood pressure monitoring
Documentation Part: Treatment Phase Day 29 An Open Label, Repeat Dose, Dose Escalation Study Conducted in Parkinson's Disease Patients to Characterize the Pharmacokinetics and Effect of Food on Ropinirole Prolonged Release (PR/CR) 12mg Tablets. ClinicalTrials.gov Identifier: NCT00460148 https://clinicaltrials.gov/ct2/show/NCT00460148?term=NCT00460148&rank=1 Responsible Party: GlaxoSmithKline

Treatment Phase Day 15 Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148

- 10/4/17 - 1 formulario, 10 itemgroups, 37 items, 1 idioma
Itemgroups: Subject information, Visit date, Urine drug screen, Alcohol test, Pregnancy test (Complete for Female Subjects of Child-bearing Potential Only), Vital signs, 12-Lead-ECG, Invesatigational product, Treatment confirmation, Ambulatory blood pressure monitoring
Documentation Part: Treatment Phase Day 15 An Open Label, Repeat Dose, Dose Escalation Study Conducted in Parkinson's Disease Patients to Characterize the Pharmacokinetics and Effect of Food on Ropinirole Prolonged Release (PR/CR) 12mg Tablets. ClinicalTrials.gov Identifier: NCT00460148 https://clinicaltrials.gov/ct2/show/NCT00460148?term=NCT00460148&rank=1 Responsible Party: GlaxoSmithKline

Treatment Phase Day 1 Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148

- 10/4/17 - 1 formulario, 11 itemgroups, 39 items, 1 idioma
Itemgroups: Subject information, Visit date, Urine drug screen, Alcohol test, Pregnancy test (Complete for Female Subjects of Child-bearing Potential Only), Vital signs, 12-Lead-ECG, Randomisation number, Invesatigational product, Treatment confirmation, Ambulatory blood pressure monitoring
Documentation Part: Treatment Phase Day 1 An Open Label, Repeat Dose, Dose Escalation Study Conducted in Parkinson's Disease Patients to Characterize the Pharmacokinetics and Effect of Food on Ropinirole Prolonged Release (PR/CR) 12mg Tablets. ClinicalTrials.gov Identifier: NCT00460148 https://clinicaltrials.gov/ct2/show/NCT00460148?term=NCT00460148&rank=1 Responsible Party: GlaxoSmithKline

Treatment Phase Day 8 Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148

- 10/4/17 - 1 formulario, 7 itemgroups, 27 items, 1 idioma
Itemgroups: Subject information, Visit date, Vital signs, 12-Lead-ECG, Invesatigational product, Treatment confirmation, Ambulatory blood pressure monitoring
Documentation Part: Treatment Phase Day 8 An Open Label, Repeat Dose, Dose Escalation Study Conducted in Parkinson's Disease Patients to Characterize the Pharmacokinetics and Effect of Food on Ropinirole Prolonged Release (PR/CR) 12mg Tablets. ClinicalTrials.gov Identifier: NCT00460148 https://clinicaltrials.gov/ct2/show/NCT00460148?term=NCT00460148&rank=1 Responsible Party: GlaxoSmithKline

Treatment Phase Day 12-14 Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148

- 10/4/17 - 1 formulario, 5 itemgroups, 24 items, 1 idioma
Itemgroups: Subject information, Visit date, Vital signs, 12-Lead-ECG, Pharmacokinetics - Blood
Documentation Part: Treatment Phase Day 12-14 (PK Assessment Day) An Open Label, Repeat Dose, Dose Escalation Study Conducted in Parkinson's Disease Patients to Characterize the Pharmacokinetics and Effect of Food on Ropinirole Prolonged Release (PR/CR) 12mg Tablets. ClinicalTrials.gov Identifier: NCT00460148 https://clinicaltrials.gov/ct2/show/NCT00460148?term=NCT00460148&rank=1 Responsible Party: GlaxoSmithKline

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

- 20/9/21 - 1 formulario, 1 itemgroup, 10 items, 1 idioma
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 3 (Visit 7) Ropinirole Parkinson Disease 101468/165 - Vital Signs Week 3 (Visit 7)

- 20/9/21 - 1 formulario, 1 itemgroup, 10 items, 1 idioma
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

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