ID
43841
Beschrijving
Study ID: 101468/196 Clinical Study ID: 101468/196 Study Title: 101468/196: A Long-Term, Open-Label Continuation Study of Once Daily Administration of Ropinirole CR Tablets to Patients with Parkinson's Disease who Completed the Previous Ropinirole CR Studies 167 or 164 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00650104 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 : Parkinson DiseaseA Long-Term, Open-Label Continuation Study of Once Daily Adminstration of Ropinirole CR Tablets to Patients with Parkinson's Disease Who Completed the Previous Ropinirole CR Studies - 167 & 164 Study Completion
Trefwoorden
Versies (2)
- 10-10-17 10-10-17 -
- 20-09-21 20-09-21 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
20 september 2021
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC-ND 3.0
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Study Completion Ropinirole in Parkinson's Disease GSK 101468/196
Study Completion Ropinirole in Parkinson's Disease GSK 101468/196
Beschrijving
Clinical Global Impression
Alias
- UMLS CUI-1
- C3639708
Beschrijving
Severity of Illness
Datatype
integer
Alias
- UMLS CUI [1]
- C0521117
Beschrijving
Global Improvement
Datatype
integer
Alias
- UMLS CUI [1]
- C3639888
Beschrijving
Study Drug Compliance
Alias
- UMLS CUI-1
- C1321605
Beschrijving
Split up in groups of 2, 3, 4 or 8 mg.
Datatype
text
Alias
- UMLS CUI [1]
- C0805077
Beschrijving
Split up in groups of 2, 3, 4 or 8mg.
Datatype
text
Alias
- UMLS CUI [1]
- C2699071
Beschrijving
Compliance
Datatype
text
Alias
- UMLS CUI [1]
- C1321605
Beschrijving
Missed Dose: Date
Datatype
date
Maateenheden
- dd-mmm-yyyy
Alias
- UMLS CUI [1,1]
- C1709043
- UMLS CUI [1,2]
- C0011008
Beschrijving
Missed Dose: Tablet
Datatype
text
Alias
- UMLS CUI [1,1]
- C1709043
- UMLS CUI [1,2]
- C0039225
Beschrijving
Missed Dose: Dosage
Datatype
float
Maateenheden
- mg
Alias
- UMLS CUI [1,1]
- C1709043
- UMLS CUI [1,2]
- C0178602
Beschrijving
Missed Dose: Reason
Datatype
text
Alias
- UMLS CUI [1,1]
- C1709043
- UMLS CUI [1,2]
- C0566251
Beschrijving
Study Drug Dosing
Alias
- UMLS CUI-1
- C0178602
Beschrijving
Orthostatic Blood Pressure/ Pulse
Alias
- UMLS CUI-1
- C1095971
Beschrijving
Time of Examination
Datatype
time
Maateenheden
- 24hr:min
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0430022
Beschrijving
Semi-Supine Heart Rate
Datatype
float
Maateenheden
- bpm
Alias
- UMLS CUI [1,1]
- C0522019
- UMLS CUI [1,2]
- C0018810
Beschrijving
Erect Heart Rate
Datatype
float
Maateenheden
- bpm
Alias
- UMLS CUI [1,1]
- C0522014
- UMLS CUI [1,2]
- C0018810
Beschrijving
Semi-Supine Systolic Blood Pressure
Datatype
float
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschrijving
Semi-Supine Diastolic Blood Pressure
Datatype
float
Maateenheden
- mmHg
Alias
- UMLS CUI [1,1]
- C0522019
- UMLS CUI [1,2]
- C0428883
Beschrijving
Erect Systolic Blood Pressure
Datatype
float
Maateenheden
- mmHg
Alias
- UMLS CUI [1,1]
- C0522014
- UMLS CUI [1,2]
- C0871470
Beschrijving
Erect Diastolic Blood Pressure
Datatype
float
Maateenheden
- mmHg
Alias
- UMLS CUI [1,1]
- C0522014
- UMLS CUI [1,2]
- C0428883
Beschrijving
Unified Parkinson's Disease Rating Scale (UPDRS)
Alias
- UMLS CUI-1
- C3639721
Beschrijving
Physical Examination
Alias
- UMLS CUI-1
- C0031809
Beschrijving
General Appearance and Skin
Datatype
integer
Alias
- UMLS CUI [1]
- C1148438
- UMLS CUI [2]
- C1123023
Beschrijving
General Appearance and Skin: Abnormality
Datatype
text
Alias
- UMLS CUI [1,1]
- C1148438
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [2,1]
- C1123023
- UMLS CUI [2,2]
- C1704258
Beschrijving
ENT Examination
Datatype
integer
Alias
- UMLS CUI [1]
- C0278350
Beschrijving
ENT Examination: Abnormality
Datatype
text
Alias
- UMLS CUI [1,1]
- C0278350
- UMLS CUI [1,2]
- C1704258
Beschrijving
Cardiovascular Examination
Datatype
integer
Alias
- UMLS CUI [1]
- C3854344
Beschrijving
Cardiovascular Examination: Abnormality
Datatype
text
Alias
- UMLS CUI [1,1]
- C3854344
- UMLS CUI [1,2]
- C1704258
Beschrijving
Respiratory Examination
Datatype
integer
Alias
- UMLS CUI [1]
- C0436121
Beschrijving
Respiratory Examination: Abnormality
Datatype
text
Alias
- UMLS CUI [1,1]
- C0436121
- UMLS CUI [1,2]
- C1704258
Beschrijving
Abdominal Examination
Datatype
integer
Alias
- UMLS CUI [1]
- C0438120
Beschrijving
Abdominal Examination: Abnormality
Datatype
text
Alias
- UMLS CUI [1,1]
- C0438120
- UMLS CUI [1,2]
- C1704258
Beschrijving
Musculoskeletal Examination
Datatype
integer
Alias
- UMLS CUI [1]
- C0026860
Beschrijving
Musculoskeletal Examination: Abnormality
Datatype
text
Alias
- UMLS CUI [1,1]
- C0026860
- UMLS CUI [1,2]
- C1704258
Beschrijving
Neurological Examination
Datatype
integer
Alias
- UMLS CUI [1]
- C0027853
Beschrijving
Neurological Examination: Abnormality
Datatype
text
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C1704258
Beschrijving
Genitourinary Examination
Datatype
integer
Alias
- UMLS CUI [1]
- C0555350
Beschrijving
Genitourinary Examination: Abnormality
Datatype
text
Alias
- UMLS CUI [1,1]
- C0555350
- UMLS CUI [1,2]
- C1704258
Beschrijving
Other Examination
Datatype
integer
Alias
- UMLS CUI [1]
- C0260879
Beschrijving
Other Examination: Abnormality
Datatype
text
Alias
- UMLS CUI [1,1]
- C0260879
- UMLS CUI [1,2]
- C1704258
Beschrijving
Laboratory Evaluations: Hematology - Complete this page only if this is a 6-months visit. Obtain blood samples at the Month 36 visit or the Study Completion Visit and then every 6 months after that. Note: Please complete the clinically significant (Clin Sig) columni for values out of normal range.
Alias
- UMLS CUI-1
- C0474523
Beschrijving
Hematology
Datatype
boolean
Alias
- UMLS CUI [1]
- C0474523
Beschrijving
Hematology: Collection Date
Datatype
date
Maateenheden
- dd-mmm-yyyy
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C1317250
Beschrijving
Hemoglobin
Datatype
float
Alias
- UMLS CUI [1]
- C0019046
Beschrijving
Hemoglobin: Unit
Datatype
text
Alias
- UMLS CUI [1,1]
- C0518015
- UMLS CUI [1,2]
- C1519795
Beschrijving
Hemoglobin: Clinically Significant
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0518015
- UMLS CUI [1,2]
- C2826633
Beschrijving
Hematocrit
Datatype
float
Alias
- UMLS CUI [1]
- C0518014
Beschrijving
Hematocrit: Unit
Datatype
text
Alias
- UMLS CUI [1,1]
- C0518014
- UMLS CUI [1,2]
- C1519795
Beschrijving
Hematocrit: Clinically Significant
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0518014
- UMLS CUI [1,2]
- C2826633
Beschrijving
Red Blood Count
Datatype
float
Alias
- UMLS CUI [1]
- C1287262
Beschrijving
Red Blood Count: Unit
Datatype
text
Alias
- UMLS CUI [1,1]
- C1287262
- UMLS CUI [1,2]
- C1519795
Beschrijving
Red Blood Count: Clinically Significant
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1287262
- UMLS CUI [1,2]
- C2826633
Beschrijving
White Blood Count
Datatype
float
Alias
- UMLS CUI [1]
- C0023508
Beschrijving
White Blood Count: Unit
Datatype
text
Alias
- UMLS CUI [1,1]
- C0023508
- UMLS CUI [1,2]
- C1519795
Beschrijving
White Blood Count: Clinically Significant
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0023508
- UMLS CUI [1,2]
- C2826633
Beschrijving
Platelets
Datatype
float
Alias
- UMLS CUI [1]
- C0005821
Beschrijving
Platelets: Unit
Datatype
text
Alias
- UMLS CUI [1,1]
- C0005821
- UMLS CUI [1,2]
- C1519795
Beschrijving
Platelets: Clinically Significant
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0005821
- UMLS CUI [1,2]
- C2826633
Beschrijving
Laboratory Evaluations: Serum Chemistry - Complete this page only if this is a 6-months visit. Obtain blood samples at the Month 36 visit or the Study Completion Visit and then every 6 months after that. Note: Please complete the clinically significant (Clin Sig) columni for values out of normal range.
Alias
- UMLS CUI-1
- C1883010
Beschrijving
Serum Chemistry
Datatype
boolean
Alias
- UMLS CUI [1]
- C1883010
Beschrijving
Serum Chemistry: Collection Date
Datatype
date
Maateenheden
- dd-mmm-yyyy
Alias
- UMLS CUI [1,1]
- C1883010
- UMLS CUI [1,2]
- C1317250
Beschrijving
Sodium
Datatype
float
Alias
- UMLS CUI [1]
- C0337443
Beschrijving
Sodium: Unit
Datatype
text
Alias
- UMLS CUI [1,1]
- C0337443
- UMLS CUI [1,2]
- C1519795
Beschrijving
Sodium: Clinically Significant
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0337443
- UMLS CUI [1,2]
- C2826633
Beschrijving
Potassium
Datatype
float
Alias
- UMLS CUI [1]
- C0202194
Beschrijving
Potassium: Unit
Datatype
text
Alias
- UMLS CUI [1,1]
- C0202194
- UMLS CUI [1,2]
- C1519795
Beschrijving
Potassium: Clinically Significant
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0202194
- UMLS CUI [1,2]
- C2826633
Beschrijving
Urea
Datatype
float
Alias
- UMLS CUI [1]
- C0523961
Beschrijving
Urea: Unit
Datatype
text
Alias
- UMLS CUI [1,1]
- C0523961
- UMLS CUI [1,2]
- C1519795
Beschrijving
Urea: Clinically Significant
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0523961
- UMLS CUI [1,2]
- C2826633
Beschrijving
Creatinine
Datatype
float
Alias
- UMLS CUI [1]
- C0201976
Beschrijving
Creatinine: Unit
Datatype
text
Alias
- UMLS CUI [1,1]
- C0201976
- UMLS CUI [1,2]
- C1519795
Beschrijving
Creatinine: Clinically Significant
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0201976
- UMLS CUI [1,2]
- C2826633
Beschrijving
Total Protein
Datatype
float
Alias
- UMLS CUI [1]
- C0555903
Beschrijving
Total Protein: Unit
Datatype
text
Alias
- UMLS CUI [1,1]
- C0555903
- UMLS CUI [1,2]
- C1519795
Beschrijving
Total Protein: Clinically Significant
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0555903
- UMLS CUI [1,2]
- C2826633
Beschrijving
Albumin
Datatype
float
Alias
- UMLS CUI [1]
- C0201838
Beschrijving
Albumin: Unit
Datatype
text
Alias
- UMLS CUI [1,1]
- C0201838
- UMLS CUI [1,2]
- C1519795
Beschrijving
Albumin: Clinically Significant
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0201838
- UMLS CUI [1,2]
- C2826633
Beschrijving
Globulin
Datatype
float
Alias
- UMLS CUI [1]
- C0877347
Beschrijving
Globulin: Unit
Datatype
text
Alias
- UMLS CUI [1,1]
- C0877347
- UMLS CUI [1,2]
- C1519795
Beschrijving
Globulin: Clinically Significant
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0877347
- UMLS CUI [1,2]
- C2826633
Beschrijving
Total Bilirubin
Datatype
float
Alias
- UMLS CUI [1]
- C0201913
Beschrijving
Total Bilirubin: Unit
Datatype
text
Alias
- UMLS CUI [1,1]
- C0201913
- UMLS CUI [1,2]
- C1519795
Beschrijving
Total Bilirubin: Clinically Significant
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0201913
- UMLS CUI [1,2]
- C2826633
Beschrijving
AST
Datatype
float
Alias
- UMLS CUI [1]
- C0201899
Beschrijving
AST: Unit
Datatype
text
Alias
- UMLS CUI [1,1]
- C0201899
- UMLS CUI [1,2]
- C1519795
Beschrijving
AST: Clinically Significant
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0201899
- UMLS CUI [1,2]
- C2826633
Beschrijving
ALT
Datatype
float
Alias
- UMLS CUI [1]
- C0201836
Beschrijving
ALT: Unit
Datatype
text
Alias
- UMLS CUI [1,1]
- C0201836
- UMLS CUI [1,2]
- C1519795
Beschrijving
ALT: Clinically Significant
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0201836
- UMLS CUI [1,2]
- C2826633
Beschrijving
Alkaline Phosphatase
Datatype
float
Alias
- UMLS CUI [1]
- C0201850
Beschrijving
Alkaline Phosphatase: Unit
Datatype
text
Alias
- UMLS CUI [1,1]
- C0201850
- UMLS CUI [1,2]
- C1519795
Beschrijving
Alkaline Phosphatase: Clinically Significant
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0201850
- UMLS CUI [1,2]
- C2826633
Beschrijving
Calcium
Datatype
float
Alias
- UMLS CUI [1]
- C0201925
Beschrijving
Calcium: Unit
Datatype
text
Alias
- UMLS CUI [1,1]
- C0201925
- UMLS CUI [1,2]
- C1519795
Beschrijving
Calcium: Clinically Significant
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0201925
- UMLS CUI [1,2]
- C2826633
Beschrijving
Phosphate
Datatype
float
Alias
- UMLS CUI [1]
- C0523826
Beschrijving
Phosphate: Unit
Datatype
text
Alias
- UMLS CUI [1,1]
- C0523826
- UMLS CUI [1,2]
- C1519795
Beschrijving
Phosphate: Clinically Significant
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0523826
- UMLS CUI [1,2]
- C2826633
Beschrijving
Non-Fasting Glucose
Datatype
float
Alias
- UMLS CUI [1,1]
- C2347359
- UMLS CUI [1,2]
- C0337438
Beschrijving
Non-Fasting Glucose: Unit
Datatype
text
Alias
- UMLS CUI [1,1]
- C2347359
- UMLS CUI [1,2]
- C0337438
- UMLS CUI [1,3]
- C1519795
Beschrijving
Non-Fasting Glucose: Clinically Significant
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2347359
- UMLS CUI [1,2]
- C0337438
- UMLS CUI [1,3]
- C2826633
Beschrijving
Pregnancy Test (betaHCG)
Alias
- UMLS CUI-1
- C0032976
Beschrijving
Pregnancy Test
Datatype
integer
Alias
- UMLS CUI [1]
- C0032976
Beschrijving
Type of Pregnancy Test
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C0332307
Beschrijving
Date of Pregnancy Test
Datatype
date
Maateenheden
- dd-mmm-yyyy
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C0011008
Beschrijving
Pregnancy Test Finding
Datatype
integer
Alias
- UMLS CUI [1]
- C0427777
Beschrijving
Screening 12-Lead Electrocardiogram Report (Originial ECGs must be kept in the patient medical charts.)
Alias
- UMLS CUI-1
- C0430456
Beschrijving
After 5 Minutes in the semi-supine position, a 12-lead ECG (using an ECG machine of adequate standard) will be performed. Six limb leads, as specified in Einthoven (I, II and III) and Goldberger (aVR, aVL, aVF), and six precordial leads (V1-V6), according to Wilson will be used. Heart rate (HR) and P-R, QRS, and QTc intervals will be assessed. The occurence of de- or repolarization disorders, arrhythmic disorders, or other abnormalities will also be assessed as per exclusion criteria 1 and 2.
Datatype
text
Beschrijving
After 5 Minutes in the semi-supine position, a 12-lead ECG (using an ECG machine of adequate standard) will be performed. Six limb leads, as specified in Einthoven (I, II and III) and Goldberger (aVR, aVL, aVF), and six precordial leads (V1-V6), according to Wilson will be used. Heart rate (HR) and P-R, QRS, and QTc intervals will be assessed. The occurence of de- or repolarization disorders, arrhythmic disorders, or other abnormalities will also be assessed as per exclusion criteria 1 and 2.
Datatype
time
Maateenheden
- 24hr:min
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0013798
Beschrijving
After 5 Minutes in the semi-supine position, a 12-lead ECG (using an ECG machine of adequate standard) will be performed. Six limb leads, as specified in Einthoven (I, II and III) and Goldberger (aVR, aVL, aVF), and six precordial leads (V1-V6), according to Wilson will be used. Heart rate (HR) and P-R, QRS, and QTc intervals will be assessed. The occurence of de- or repolarization disorders, arrhythmic disorders, or other abnormalities will also be assessed as per exclusion criteria 1 and 2.
Datatype
float
Maateenheden
- bpm
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
After 5 Minutes in the semi-supine position, a 12-lead ECG (using an ECG machine of adequate standard) will be performed. Six limb leads, as specified in Einthoven (I, II and III) and Goldberger (aVR, aVL, aVF), and six precordial leads (V1-V6), according to Wilson will be used. Heart rate (HR) and P-R, QRS, and QTc intervals will be assessed. The occurence of de- or repolarization disorders, arrhythmic disorders, or other abnormalities will also be assessed as per exclusion criteria 1 and 2.
Datatype
float
Maateenheden
- sec
Alias
- UMLS CUI [1]
- C0429087
Beschrijving
After 5 Minutes in the semi-supine position, a 12-lead ECG (using an ECG machine of adequate standard) will be performed. Six limb leads, as specified in Einthoven (I, II and III) and Goldberger (aVR, aVL, aVF), and six precordial leads (V1-V6), according to Wilson will be used. Heart rate (HR) and P-R, QRS, and QTc intervals will be assessed. The occurence of de- or repolarization disorders, arrhythmic disorders, or other abnormalities will also be assessed as per exclusion criteria 1 and 2.
Datatype
float
Maateenheden
- sec
Alias
- UMLS CUI [1]
- C0520880
Beschrijving
After 5 Minutes in the semi-supine position, a 12-lead ECG (using an ECG machine of adequate standard) will be performed. Six limb leads, as specified in Einthoven (I, II and III) and Goldberger (aVR, aVL, aVF), and six precordial leads (V1-V6), according to Wilson will be used. Heart rate (HR) and P-R, QRS, and QTc intervals will be assessed. The occurence of de- or repolarization disorders, arrhythmic disorders, or other abnormalities will also be assessed as per exclusion criteria 1 and 2.
Datatype
float
Maateenheden
- sec
Alias
- UMLS CUI [1]
- C0855331
Beschrijving
ECG Finding
Datatype
text
Alias
- UMLS CUI [1]
- C0438154
Beschrijving
ECG Finding: Clinically Significant
Datatype
text
Alias
- UMLS CUI [1,1]
- C0438154
- UMLS CUI [1,2]
- C2826633
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C1704258 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
C1317250 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
C2826633 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
C2826633 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
C2826633 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
C2826633 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
C2826633 (UMLS CUI [1,2])
C1317250 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
C2826633 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
C2826633 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
C2826633 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
C2826633 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
C2826633 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
C2826633 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
C2826633 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
C2826633 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
C2826633 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
C2826633 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
C2826633 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
C2826633 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
C2826633 (UMLS CUI [1,2])
C0337438 (UMLS CUI [1,2])
C0337438 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
C0337438 (UMLS CUI [1,2])
C2826633 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0013798 (UMLS CUI [1,2])
C2826633 (UMLS CUI [1,2])