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

- 2021-09-20 - 1 Formulär, 18 Item-grupper, 90 Dataelement, 1 Språk
Item-grupper: 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

Serious adverse events GSK study Dyskinesia in Parkinson's disease NCT00363727

- 2021-09-20 - 1 Formulär, 14 Item-grupper, 62 Dataelement, 1 Språk
Item-grupper: General information, Serious adverse events, Serious adverse events description, Seriousness, Demography data, Recurrence of SAE, Possible Causes of SAE, Relevant medical conditions, Other relevant risk factors, Concomitant medications relevant to SAE, Details of Investigational Product, Details of relevant Assessments, Narrative Remarks, Investigator information
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: Serious adverse events

inital & follow-up report serious adverse events starting dose of ropinirole Parkinson's Disease 101468/166

- 2021-03-15 - 1 Formulär, 6 Item-grupper, 32 Dataelement, 1 Språk
Item-grupper: time of documentation, patient information, adverse event, study drug, patient information, principal investigator
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

Adverse Events & Concomitant Medications Week 3 (Visit 7) Ropinirole Parkinson Disease 101468/165 - Adverse Events & Concomitant Medications Week 3 (Visit 7)

- 2019-10-30 - 1 Formulär, 1 Item-grupp, 5 Dataelement, 1 Språk
Item-grupp: Adverse Events; Concomitant Medications
Study Part: Adverse Events & Concomitant Medications 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

Serious adverse events Ropinirole CR Ropinirole IR Monotherapy 101468/168

- 2017-10-18 - 1 Formulär, 14 Item-grupper, 56 Dataelement, 1 Språk
Item-grupper: administrative data, Serious adverse event, Serious adverse event, Seriousness, Demography data, Recurrence of SAE, Possible Causes of SAE Other Than Investigational Product, Relevant Medical Conditions, Other relevant risk factors, Relevant concomitant medications, Details of Investigational Product, Details of relevant Assessments, Narrative Remarks, Investigator information
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

Non-serious adverse events Ropinirole CR Ropinirole IR Monotherapy 101468/168

- 2017-10-18 - 1 Formulär, 3 Item-grupper, 11 Dataelement, 1 Språk
Item-grupper: administrative data, Non-serious adverse events, Non-serious adverse events
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

Adverse Events Week 2 PK Visit (Visit 6) Ropinirole Parkinson Disease 101468/165 - Adverse Events Week 2 PK Visit (Visit 6)

- 2017-10-17 - 1 Formulär, 3 Item-grupper, 9 Dataelement, 1 Språk
Item-grupper: Adverse Events, ADVERSE EVENTS, ADVERSE EVENTS
Study Part: Adverse Events 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

Adverse Events & Concomitant Medications Week 2 PK Through 2 (Visit 5) Ropinirole Parkinson Disease 101468/165 - Adverse Events & Concomitant Medications Week 2 PK Through 2 (Visit 5)

- 2017-10-16 - 1 Formulär, 1 Item-grupp, 5 Dataelement, 1 Språk
Item-grupp: Adverse Events; Concomitant Medications
Study Part: Adverse Events & Concomitant Medications Week 2 PK Through 2 (Visit 5). 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

Adverse Events & Concomitant Medications Week 2 PK Through 1 (Visit 4) Ropinirole Parkinson Disease 101468/165 - Adverse Events & Concomitant Medications Week 2 PK Through 1 (Visit 4)

- 2017-10-16 - 1 Formulär, 1 Item-grupp, 5 Dataelement, 1 Språk
Item-grupp: Adverse Events; Concomitant Medications
Study Part: Adverse Events & Concomitant Medications Week 2 PK Through 1 (Visit 4). 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

Adverse Events Week 1 PK Visit (Visit 3) Ropinirole Parkinson Disease 101468/165 - Adverse Events Week 1 PK Visit (Visit 3)

- 2017-10-16 - 1 Formulär, 3 Item-grupper, 9 Dataelement, 1 Språk
Item-grupper: Adverse Events, ADVERSE EVENTS, ADVERSE EVENTS
Study Part: Adverse Events 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

Adverse Events & Concomitant Medications Week 1 Day 1 (Visit 2) Ropinirole Parkinson Disease 101468/165 - Adverse Events & Concomitant Medications Week 1 Day 1 (Visit 2)

- 2017-10-16 - 1 Formulär, 1 Item-grupp, 5 Dataelement, 1 Språk
Item-grupp: Adverse Events; Concomitant Medications
Study Part: Adverse Events & Concomitant Medications 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

Baseline Signs and Symptoms Week 1 Pre-dose (Visit 1) Ropinirole Parkinson Disease 101468/165 - Baseline Signs and Symptoms Week 1 Pre-dose (Visit 1)

- 2017-10-16 - 1 Formulär, 1 Item-grupp, 13 Dataelement, 1 Språk
Item-grupp: Signs and Symptoms
Study Part: Baseline Signs and Symptoms 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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