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  1. 1. Klinische Studie
  2. 2. Routinedokumentation
  3. 3. Register-/Kohortenstudien
  4. 4. Qualitätssicherung
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Vital Signs Screening Ropinirole Parkinson Disease 101468/165 - Vital Signs Screening

- 20.09.21 - 1 Formular, 1 Itemgruppe, 10 Datenelemente, 1 Sprache
Itemgruppe: 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 1 Pre-dose (Visit 1)Ropinirole Parkinson Disease 101468/165 - Vital Signs Week 1 Pre-dose (Visit 1)

- 20.09.21 - 1 Formular, 1 Itemgruppe, 11 Datenelemente, 1 Sprache
Itemgruppe: Vital Signs
Study Part: Vital Signs 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

Vital Signs Week 1 Day 1 (Visit 2) Ropinirole Parkinson Disease 101468/165 - Vital Signs Week 1 Day 1 (Visit 2)

- 20.09.21 - 1 Formular, 1 Itemgruppe, 10 Datenelemente, 1 Sprache
Itemgruppe: Vital Signs
Study Part: Vital Signs 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

Lebendspende NTX Befund MS University Hospital Muenster (UKM)

- 20.09.21 - 1 Formular, 3 Itemgruppen, 52 Datenelemente, 1 Sprache
Itemgruppen: General information, Diagnostics of antigens and antibodies, Examinations
Hospital Routine Documentation Form at the University Hospital Muenster. Original Form name: Lebendspende NTX Befund MS.

Visit V0 LAIS grass tablets by allergic rhinoconjunctivitis EudraCT-Nr.2012-004916-79 - Visit V0 Screening visit

- 20.09.21 - 1 Formular, 18 Itemgruppen, 157 Datenelemente, 1 Sprache
Itemgruppen: Inclusion Criteria, Exclusion Criteria, demographics, Laboratory, Physical examination, Medical Examination Rhinoscope, History of allergies, Clinical symptoms, Score Rhinoconjunctivitis, Concomitant medication, medical history, skin prick test, Spirometry; Peak Expiratory Flow, Conjunctival provocation testing, diagnostics allergy, Hematology, Biochemistry, Inclusion Criteria
Study part: Visit V0 Screening visit. Effectiveness and tolerance of sublingual desensitization with LAIS grass tablets in Patients with an allergic rhinoconjunctivitis caused by grass pollen. A prospective, multi-center, doubleblind, randomized, placebo-controlled Phase III study. Principal Investigator Prof. Dr. med. Ralph Mösges.

Vital Signs (VS) Ropinirole Restless Legs Syndrom NCT00355641 - Vital Signs

- 20.09.21 - 1 Formular, 4 Itemgruppen, 18 Datenelemente, 1 Sprache
Itemgruppen: Vital Signs, Pre- dose, post dose, post dose
Study part: Vital Signs. 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.

Vital Signs Week 4 PK Visit (Visit 8) Ropinirole Parkinson Disease 101468/165 - Vital Signs Week 4 PK Visit (Visit 8)

- 20.09.21 - 1 Formular, 1 Itemgruppe, 11 Datenelemente, 1 Sprache
Itemgruppe: Vital Signs
Study Part: Vital Signs Week 4 PK Visit (Visit 8). 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 5 PK Visit (Visit 9) Ropinirole Parkinson Disease 101468/165 - Vital Signs Week 5 PK Visit (Visit 9)

- 20.09.21 - 1 Formular, 1 Itemgruppe, 11 Datenelemente, 1 Sprache
Itemgruppe: Vital Signs
Study Part: Vital Signs Week 5 PK Visit (Visit 9). 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

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

- 20.09.21 - 1 Formular, 1 Itemgruppe, 10 Datenelemente, 1 Sprache
Itemgruppe: Vital Signs
Study Part: Unscheduled Vital Signs. 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

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

- 20.09.21 - 1 Formular, 27 Itemgruppen, 251 Datenelemente, 1 Sprache
Itemgruppen: 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

On-Study - PHYSICAL EXAM SCREEN - 2390964v1.0 - PHYSICAL EXAM SCREEN

- 20.09.21 - 1 Formular, 2 Itemgruppen, 6 Datenelemente, 1 Sprache
Itemgruppen: PHYSICAL EXAM--SCREENING, COMMENTS
Physical Exam Screening form for C3D 3.12 Adopters Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=FEF2E3DC-3E2D-329B-E034-0003BA3F9857

On-Study - PHYSICAL EXAM - 2407645v1.0 - PHYSICAL EXAM

- 20.09.21 - 1 Formular, 2 Itemgruppen, 8 Datenelemente, 1 Sprache
Itemgruppen: PHYSICAL EXAM, COMMENTS
Physical Exam form for C3D 3.12 Adopters Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=01603C3C-DD2D-4BA2-E044-0003BA3F9857

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