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Effect of ropinirole on cardiac conduction as assessed by 12-lead electrocardiogram (101468/902) - Laboratory Collections

- 26-05-20 - 1 Formulier, 7 Itemgroepen, 22 Data-elementen, 1 Taal

Itemgroepen: Administrative, Clinical Chemistry & Haematology, Urinalysis, Drug Screening (Urine), Contra-indicated drugs, Alcohol Urine/ Breath Test, Research Physician’s Signatur

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

Effect of ropinirole on cardiac conduction as assessed by 12-lead electrocardiogram (101468/902) - Dosing Details; ECG Monitoring; Safety ECG Monitoring

- 21-05-20 - 1 Formulier, 8 Itemgroepen, 27 Data-elementen, 1 Taal

Itemgroepen: Administrative, Dosing Details, Dosing Details, ECG Monitoring - Supine, ECG Monitoring - Supine , ECG Monitoring - Supine (Follow-Up), Safety ECG Monitoring - Supine , ECG Monitoring - Supine - Research Physician's Signature

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

Effect of ropinirole on cardiac conduction as assessed by 12-lead electrocardiogram (101468/902) - Predose Restriction List; Meals and Fluid Intake

- 20-05-20 - 1 Formulier, 4 Itemgroepen, 22 Data-elementen, 1 Taal

Itemgroepen: Administrative, Predose Restriction List, Meals and Fluid Intake, Meals and Fluid Intake

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

Effect of ropinirole on cardiac conduction as assessed by 12-lead electrocardiogram (101468/902) - Significant Medical/ Surgical History; Physical Examination; Pregnancy Test

- 20-05-20 - 1 Formulier, 9 Itemgroepen, 28 Data-elementen, 1 Taal

Itemgroepen: Administrative, Significant Medical/ Surgical History (Period 1 Day -1), Significant Medical/ Surgical History (Period 2 Day -1), Significant Medical/ Surgical History , Physical Examination (Period 1 Day -1), Physical Examination (Period 2 Day -1), Physical Examination (Follow-Up) , Physical Examination - Investigator's Signature, Pregnancy Test (Females only)

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 and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/218 - Diary Card Week 1, Diary Card Week X

- 14-05-20 - 1 Formulier, 7 Itemgroepen, 28 Data-elementen, 1 Taal

Itemgroepen: Administrative, Diary Card Week 1, Symptoms Week 1, Actigraphy and sleep EEG recording - Week 1 Dose Level = 2, Diary Card Week X, Symptoms Week X, Actigraphy and sleep EEG recording - Week X Dose Level = X

Study ID: 101468/218 Clinical Study ID: SKF-101468/218 Study Title:A Single-Blind, Randomised, Placebo-Controlled, Parallel-Group, Multicentre, Phase IIa Study to Determine the Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome

Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/218 - Form D; Missing Data; Clinical Data Review

- 13-05-20 - 1 Formulier, 5 Itemgroepen, 37 Data-elementen, 1 Taal

Itemgroepen: Administrative, Form D, Missing Data, Clinical Data Review - Administrative, Clinical Data Review - Review comments

Study ID: 101468/218 Clinical Study ID: SKF-101468/218 Study Title:A Single-Blind, Randomised, Placebo-Controlled, Parallel-Group, Multicentre, Phase IIa Study to Determine the Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome

Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/218 - Concomitant Medication; Adverse Event; Serious Adverse Event

- 13-05-20 - 1 Formulier, 9 Itemgroepen, 56 Data-elementen, 1 Taal

Itemgroepen: Administrative, Concomitant Medication, Concomitant Medication , Adverse Event, Adverse Event , Advrese Event - Investigator’s Signature, Serious Adverse Event, Serious Adverse Event - Relevant Laboratory Data, Serious Adverse Event - Investigator's Signature

Study ID: 101468/218 Clinical Study ID: SKF-101468/218 Study Title:A Single-Blind, Randomised, Placebo-Controlled, Parallel-Group, Multicentre, Phase IIa Study to Determine the Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome

Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/218 - Return of Study Medication

- 11-05-20 - 1 Formulier, 2 Itemgroepen, 5 Data-elementen, 1 Taal

Itemgroepen: Administrative, Return of Study Medication

Study ID: 101468/218 Clinical Study ID: SKF-101468/218 Study Title:A Single-Blind, Randomised, Placebo-Controlled, Parallel-Group, Multicentre, Phase IIa Study to Determine the Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome

Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/218 - Pregnancy Information; Study Conclusion, Investigator's Statement (Follow-Up)

- 08-05-20 - 1 Formulier, 4 Itemgroepen, 17 Data-elementen, 1 Taal

Itemgroepen: Administrative, Pregnancy Information, Study Conclusion, Investigator's Statement

Study ID: 101468/218 Clinical Study ID: SKF-101468/218 Study Title:A Single-Blind, Randomised, Placebo-Controlled, Parallel-Group, Multicentre, Phase IIa Study to Determine the Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome

Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/218 - Laboratory Collections; Urinalysis Test Results; Hepatitis B Surface Antigen, Hepatitis C Antibodies and HIVI/II Antibodies

- 08-05-20 - 1 Formulier, 8 Itemgroepen, 28 Data-elementen, 1 Taal

Itemgroepen: Administrative, Laboratory Collections - Clinical Chemistry & Haematology (Screening), Laboratory Collections - Clinical Chemistry & Haematology (Follow-Up), Laboratory Collections - Drug Screening (Urine), Urinalysis Test Results (Screening), Urinalysis Test Results (Follow-Up), Urinalysis Test Results - Results for dip stick test:, Hepatitis B Surface Antigen, Hepatitis C Antibodies and HIVI/II Antibodies

Study ID: 101468/218 Clinical Study ID: SKF-101468/218 Study Title:A Single-Blind, Randomised, Placebo-Controlled, Parallel-Group, Multicentre, Phase IIa Study to Determine the Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome

Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/218 - Smoking History; RLS Pharmacotherapy History; Vital Signs; 12 Lead ECG Monitoring

- 08-05-20 - 1 Formulier, 6 Itemgroepen, 30 Data-elementen, 1 Taal

Itemgroepen: Patient administration, Smoking History (Screening), RLS Pharmacotherapy History (Screening), RLS Pharmacotherapy History (Screening), Vital Signs (Screening), 12 Lead ECG Monitoring

Study ID: 101468/218 Clinical Study ID: SKF-101468/218 Study Title:A Single-Blind, Randomised, Placebo-Controlled, Parallel-Group, Multicentre, Phase IIa Study to Determine the Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome

Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/218 - Predose Checklist; Las Visit Checklist

- 08-05-20 - 1 Formulier, 5 Itemgroepen, 37 Data-elementen, 1 Taal

Itemgroepen: Administrative, Predose Checklist (Day 1), Predose Checklist (Day 3; Extra Clinic Visit 1- 3), Predose Checklist (Day 15, Day 22, Day 29, Day 36, Day 43), Last Visit Checklist

Study ID: 101468/218 Clinical Study ID: SKF-101468/218 Study Title:A Single-Blind, Randomised, Placebo-Controlled, Parallel-Group, Multicentre, Phase IIa Study to Determine the Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome

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