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Effect of ropinirole on cardiac conduction as assessed by 12-lead electrocardiogram (101468/902) - Follow-Up - Pregnancy Information; Study Conclusion; Investigator's Statement; General Comments

- 29/5/20 - 1 formulario, 5 itemgroups, 18 items, 1 idioma

Itemgroups: Administrative, Pregnancy Information, Study Conclusion, Investigator's Statement, General Comments

Study ID: 101468/902 Clinical Study ID: 101468/902 Study Title:A study to evaluate the effect of repeated oral doses of ropinirole on cardiac conduction as assessed by 12-lead electrocardiogram compared to placebo and single oral doses of moxifloxacin (Bayer) as a positive control. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline 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

Pharmacokinetics of a new unmarketed formulation of ropinirole Follow-up 101468/199 - Follow-up

- 27/10/17 - 1 formulario, 10 itemgroups, 92 items, 1 idioma

Itemgroups: Pregnancy test, Physical examination, 12-lead ECG, Vital signs, Laboratory Result Data Haematology, Laboratory Result Data Clinical Chemistry, Urinalysis, Dipstick Test, Status of Treatment Blind, Investigational Product Discontinuation - Ropinirole, Concomitant Medications

Study ID: 101468/199 Clinical Study ID: 101468/199 Study Title: An open label study conducted in healthy volunteers to characterize the pharmacokinetics of a new unmarketed formulation of ropinirole 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 Documentation part (Visit Description): Follow-up

Ropinirole in Patients with Restless Legs Syndrome (Study ID: 101468/194) - Follow-up

- 6/3/19 - 1 formulario, 8 itemgroups, 15 items, 1 idioma

Itemgroups: Administrative documentation, Restless Legs Syndrome, Score, Vital signs, Medical procedure, Concomitant Agent, Adverse Event, Laboratory Procedures, Evaluation, Urine dipstick test

Study ID: 101468/194 Clinical Study ID: 101468/194 Study Title: A 12 Week, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety 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 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome

Determination of starting dose and up-titration regimen for a new formulation of Ropinirole in healthy adults, 101468/201 - Physical Examination Follow- Up

- 21/6/19 - 1 formulario, 2 itemgroups, 5 items, 1 idioma

Itemgroups: Administrative Data, Physical Examination

Study ID: 101468/201 Clinical Study ID: 101468/201 Study Title: A Single Blind, Parallel Group, Up-titration, Phase 1 Study in Healthy Volunteers to Determine a Starting Dose and Select an Up-titration Regimen for a new Formulation of Ropinirole 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 The Study consists of 21 Visits(Days): Screening (at least 21 days before dosing) Week 1: including Day 1-7 Week 2: including Day 8-14 Week 3: including Day 15-19 Follow-up Visit (7-14 days after last dose) This document contains the Physical Examination Follow- Up form. It has to be filled in at follow-up.

Determination of starting dose and up-titration regimen for a new formulation of Ropinirole in healthy adults, 101468/201 - Laboratory Collections, Urinalaysis, Pregnancy test follow-up

- 21/6/19 - 1 formulario, 4 itemgroups, 17 items, 1 idioma

Itemgroups: Administrative Data, Laboratory Collection - Clinical chemistry and haematology, Laboratory Collection - Urinalysis, Pregnancy test

Study ID: 101468/201 Clinical Study ID: 101468/201 Study Title: A Single Blind, Parallel Group, Up-titration, Phase 1 Study in Healthy Volunteers to Determine a Starting Dose and Select an Up-titration Regimen for a new Formulation of Ropinirole 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 The Study consists of 21 Visits(Days): Screening (at least 21 days before dosing) Week 1: including Day 1-7 Week 2: including Day 8-14 Week 3: including Day 15-19 Follow-up Visit (7-14 days after last dose) This document contains the Laboratory Collections, Urinalaysis and Pregnancy test for follow-up form. It has to be filled in at Follow-up.

Follow-Up GSK Ropinirole Restless Legs Syndrome 101468

- 13/9/17 - 1 formulario, 11 itemgroups, 77 items, 1 idioma

Itemgroups: 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

Follow-Up GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/190

- 18/10/17 - 1 formulario, 8 itemgroups, 14 items, 1 idioma

Itemgroups: General Information, RLS RATING SCALE, VITAL SIGNS, MEDICAL PROCEDURES, CONCOMITANT MEDICATION, ADVERSE EXPERIENCES, LABORATORY EVALUATION, URINE DIPSTICK

Study ID: 101468/190 Clinical Study ID: SKF-101468/190 Study Title:A 12 Week, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety 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 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Requip Study Indication: Restless Legs Syndrome This is the mandatory 7 day follow-up assessment form.

GSK study: Ropinirole in RLS patients 101468/243 - Follow up - GSK study: Ropinirole in RLS patients 101468/243 - Follow-up

- 30/7/17 - 1 formulario, 18 itemgroups, 52 items, 1 idioma

Itemgroups: RLS Rating scale, Vital signs, Concomitant Medication, Adverse reaction, Medical procedures, Laboratory test, Urine dipstick, Study medication and compliance record, Dose changes, Medical procedures, Medical procedures, Concomitant medication, concomitant medication, Non-serious adverse event, Non-serious adverse event, Pregnancy information, Study conclusion, investigator signature

Part 2 of Module 12: Wk 52, Follow-Up & Study Conc 101468/243 Study ID: 101468/243 Clinical Study ID: 101468/243 Study Title: A 52 Week Open-Label Extension Study of the Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 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

GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/188 - Week 28

- 6/11/17 - 1 formulario, 7 itemgroups, 29 items, 1 idioma

Itemgroups: Vital signs, Healthcare resource utilisation - Visits/Contacts with Physicians, Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners, Healthcare resource utilisation - Hospitalisation, Healthcare resource utilisation - accident & emergency / emergency room visits, Patient Rated Scales, Ramos Randomisation and Dispensing

Study ID: 101468/188 Clinical Study ID: SKF-101468/188 Study Title:A Study of the Maintained Efficacy and Safety of Ropinirole Versus Placebo in the Long Term Treatment of Restless Legs Syndrome (RLS) 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: Requip Study Indication: Parkinson Disease Module: Week 28

GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/188 - Week 12

- 6/11/17 - 1 formulario, 6 itemgroups, 27 items, 1 idioma

Itemgroups: Vital signs, Healthcare resource utilisation - Visits/Contacts with Physicians, Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners, Healthcare resource utilisation - Hospitalisation, Healthcare resource utilisation - accident & emergency / emergency room visits, Patient Rated Scales

Study ID: 101468/188 Clinical Study ID: SKF-101468/188 Study Title:A Study of the Maintained Efficacy and Safety of Ropinirole Versus Placebo in the Long Term Treatment of Restless Legs Syndrome (RLS) 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: Requip Study Indication: Parkinson Disease Module: Week 12

GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/188 - Concomitant Medication

- 6/11/17 - 1 formulario, 1 itemgroup, 7 items, 1 idioma

Itemgroup: Concomitant Medication

Study ID: 101468/188 Clinical Study ID: SKF-101468/188 Study Title:A Study of the Maintained Efficacy and Safety of Ropinirole Versus Placebo in the Long Term Treatment of Restless Legs Syndrome (RLS) 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: Requip Study Indication: Parkinson Disease Module: Concomitant Medication (Follow-Up)

GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/188 - Mandatory 7 Day Follow Up Assessment

- 6/11/17 - 1 formulario, 2 itemgroups, 6 items, 1 idioma

Itemgroups: Vital signs, Laboratory Evaluation

Study ID: 101468/188 Clinical Study ID: SKF-101468/188 Study Title:A Study of the Maintained Efficacy and Safety of Ropinirole Versus Placebo in the Long Term Treatment of Restless Legs Syndrome (RLS) 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: Requip Study Indication: Parkinson Disease Module: Mandatory 7 Day Follow Up Assessment

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