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Anxiety And Depression Scale (HADS) Ropinirole Restless Legs Syndrom NCT00355641 - Anxiety And Depression Scale

- 27-09-21 - 1 Formulier, 1 Itemgroep, 1 Data-element, 1 Taal

Itemgroep: Hospital anxiety and depression scale

Study part: Anxiety And Depression Scale. A 52-Week, Open-Label Study to Assess the Long-Term Safety of Ropinirole Extended Release (XR) in Patients with Restless Legs Syndrome (RLS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Clinicaltrials.gov Identifier: NCT00355641. 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. Study ID: 101468/206. Clinical Study ID: 101468/206.

Effect of ropinirole on cardiac conduction as assessed by 12-lead electrocardiogram (101468/902) - Pharmacogenetic Research; Prior Medication; Baseline Signs and Symptoms

- 27-09-21 - 1 Formulier, 6 Itemgroepen, 32 Data-elementen, 1 Taal

Itemgroepen: Administrative, Pharmacogenetic Research, Prior Medication, Prior Medication , Baseline Signs and Symptoms, Baseline Signs and Symptoms - Investigator'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

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

- 20-09-21 - 1 Formulier, 15 Itemgroepen, 79 Data-elementen, 1 Taal

Itemgroepen: Administrative documentation, Restless Legs Syndrome, Screening procedure, Medical History, Restless Legs Syndrome, Diagnostic criteria, Demography, Vital Signs, Taking orthostatic vital signs, 12 lead ECG, Physical Examination, Laboratory Procedures, Evaluation, Urine dipstick test, Urine pregnancy test, Medical History, History of surgical procedures, Physical Examination, Prior Medication Usage; Concomitant Agent, Restless Legs Syndrome, Pharmaceutical Preparations, Medical History, Eligibility Determination

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

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

- 20-09-21 - 1 Formulier, 8 Itemgroepen, 32 Data-elementen, 1 Taal

Itemgroepen: Administrative documentation, Eligibility Determination, Vital signs, Concomitant Agent, Medical procedure, Signs and Symptoms, Employment status, Baseline, Randomization, Dispensing medication

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

Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/218 - Dose Level 1, Day1, Pre-dose - Prior Medication; Pregnancy Test; Alcohol Breath Test; Drug Screening (Urine); Vital Signs

- 20-09-21 - 1 Formulier, 7 Itemgroepen, 31 Data-elementen, 1 Taal

Itemgroepen: Administrative, Prior Medication, Prior Medication , Pregnancy Test, Alcohol Breath Test, Drug Screening (Urine) , Vital Signs

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 - Prior Medication

- 20-09-21 - 1 Formulier, 3 Itemgroepen, 11 Data-elementen, 1 Taal

Itemgroepen: Administrative, Prior Medication, Prior 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

Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198 - Prior Medication

- 20-09-21 - 1 Formulier, 2 Itemgroepen, 12 Data-elementen, 1 Taal

Itemgroepen: Administrative data, Prior Medication

Study ID: 101468/198 Clinical Study ID: 101468/198 Study Title:An open, randomised, crossover, healthy volunteer study to compare the PK and tolerability of ropinirole as 3 different new formulations with the standard marketed formulation and to study the effects of a high fat meal on a new formulation 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 a Screening, 5 Sessions each with 2 days and a Follow-up. This document contains the prior medication form. It has to be filled in for screening.

Efficacy and Safety of Ropinirole XR (Extended Release) in Patients with Restless Legs Syndrome NCT00197080 - Screening - Eligibility Question

- 20-09-21 - 1 Formulier, 2 Itemgroepen, 22 Data-elementen, 1 Taal

Itemgroepen: Inclusion Criteria, Exclusion criteria

Study ID: 101468/205 Clinical Study ID: 101468/205 Study Title:A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole XR (Extended Release) in Patients with Restless Legs Syndrome Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00197080 Sponsor: GlaxoSmithKline 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

Efficacy and Safety of Ropinirole XR (Extended Release) in Patients with Restless Legs Syndrome NCT00197080 - Ambulatory Blood Pressuure Monitoring Diary; Equipment Request

- 20-09-21 - 1 Formulier, 5 Itemgroepen, 18 Data-elementen, 1 Taal

Itemgroepen: When dispensed?, Administrative, Ambulatory Blood Pressure Monitoring Diary, Blood Pressure Measurement, Equipment Request

Study ID: 101468/205 Clinical Study ID: 101468/205 Study Title:A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole XR (Extended Release) in Patients with Restless Legs Syndrome Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00197080 Sponsor: GlaxoSmithKline 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

Efficacy and Safety of Ropinirole XR (Extended Release) in Patients with Restless Legs Syndrome NCT00197080 - Baseline - Eligibility Question

- 20-09-21 - 1 Formulier, 3 Itemgroepen, 27 Data-elementen, 1 Taal

Itemgroepen: Eligibility Question, Inclusion Criteria, Exclusion criteria

Study ID: 101468/205 Clinical Study ID: 101468/205 Study Title:A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole XR (Extended Release) in Patients with Restless Legs Syndrome Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00197080 Sponsor: GlaxoSmithKline 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

Demography Ropinirole Restless Legs Syndrom NCT00355641 - Demography

- 20-09-21 - 1 Formulier, 1 Itemgroep, 4 Data-elementen, 1 Taal

Itemgroep: Demography

Study part: Demography.A 52-Week, Open-Label Study to Assess the Long-Term Safety of Ropinirole Extended Release (XR) in Patients with Restless Legs Syndrome (RLS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Clinicaltrials.gov Identifier: NCT00355641. 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. Study ID: 101468/206. Clinical Study ID: 101468/206.

baseline signs and symptoms PK and tolerability of ropinirole as 5 new formulations 101468/197

- 20-09-21 - 1 Formulier, 3 Itemgroepen, 12 Data-elementen, 1 Taal

Itemgroepen: administrative data, signs and symptoms, events

Study ID: 101468/197 Clinical Study ID: SKF-101468/197 Study Title:An open study to compare the PK and tolerability of ropinirole administered as 5 different new formulations with the standard, marketed formulation in healthy volunteers 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: Requip Study Indication : Restless Legs Syndrome

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