ID
26188
Beschrijving
Follow-up - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164 Study ID: 101468/164 Clinical Study ID: 101468/164 Study Title: An open-label, randomised, two part study to investigate the relative bioavailability of Ropinirole new and standard, marketed formulations and the effect of food on the pharmacokinetics of Ropinirole new formulation in early stage Parkinson’s disease subjects 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
Trefwoorden
Versies (1)
- 10-10-17 10-10-17 -
Houder van rechten
glaxoSmithKline
Geüploaded op
10 oktober 2017
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
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Follow-up - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164
Follow-up - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164
Beschrijving
Adverse event
Alias
- UMLS CUI-1
- C0877248
Beschrijving
Patient diary
Alias
- UMLS CUI-1
- C3890583
Beschrijving
Patient diary
Datatype
text
Alias
- UMLS CUI [1]
- C3890583
Beschrijving
12-lead electrocardiogram report
Alias
- UMLS CUI-1
- C0430456
Beschrijving
time of ECG
Datatype
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0013798
Beschrijving
heart rate
Datatype
integer
Maateenheden
- bpm
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0018810
Beschrijving
P-R interval
Datatype
float
Maateenheden
- sec
Alias
- UMLS CUI [1]
- C0429087
Beschrijving
QRS Interval
Datatype
float
Maateenheden
- sec
Alias
- UMLS CUI [1]
- C0520880
Beschrijving
QTc interval
Datatype
float
Maateenheden
- sec
Alias
- UMLS CUI [1]
- C0855331
Beschrijving
ECG results
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C1274040
Beschrijving
Original ECGs must be kept in the patient medical charts
Datatype
text
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C1521902
Beschrijving
orthostatic blood pressure / Pulse
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C1095971
- UMLS CUI-3
- C0232117
Beschrijving
Date of visit
Datatype
date
Alias
- UMLS CUI [1]
- C1320303
Beschrijving
Heart rate Semi-Supine
Datatype
integer
Maateenheden
- bpm
Alias
- UMLS CUI [1,1]
- C0018810
- UMLS CUI [1,2]
- C0038846
Beschrijving
Heart Rate standing
Datatype
integer
Maateenheden
- bpm
Alias
- UMLS CUI [1]
- C2029905
Beschrijving
Systolic blood pressure semi-supine
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0038846
Beschrijving
Diastolic blood pressure semi-supine
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0038846
Beschrijving
Systolic blood pressure standing
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0231472
Beschrijving
Diastolic blood pressure standing
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1,1]
- C1303019
- UMLS CUI [1,2]
- C3812758
Beschrijving
Pregnancy test
Alias
- UMLS CUI-1
- C0032976
Beschrijving
pregnancy test
Datatype
integer
Beschrijving
pregnancy test
Datatype
integer
Alias
- UMLS CUI [1]
- C0032976
Beschrijving
Date of pregnancy test
Datatype
date
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C0011008
Beschrijving
Result of pregnancy test
Datatype
integer
Alias
- UMLS CUI [1]
- C0427777
Beschrijving
Physical examination
Alias
- UMLS CUI-1
- C0031809
Beschrijving
Body system
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1268086
- UMLS CUI [1,2]
- C0449913
Beschrijving
Body system abnormality
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0460002
- UMLS CUI [1,2]
- C1704258
Beschrijving
Describe abnormality body system
Datatype
text
Alias
- UMLS CUI [1,1]
- C0459424
- UMLS CUI [1,2]
- C0031809
- UMLS CUI [1,3]
- C0678257
Beschrijving
strenuous activity
Datatype
boolean
Alias
- UMLS CUI [1]
- C1514989
Beschrijving
Hematology Laboratory evaluation
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0200627
Beschrijving
Hematology Laboratory evaluation
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0200627
Beschrijving
Analyte
Datatype
integer
Alias
- UMLS CUI [1]
- C0443354
Beschrijving
laboratory Result
Datatype
text
Alias
- UMLS CUI [1]
- C0587081
Beschrijving
Unit laboratory result
Datatype
text
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
Clinical significant result
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0456984
- UMLS CUI [1,2]
- C0750502
Beschrijving
Serum Laboratory evaluation
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0229671
Beschrijving
Serum laboratory evaluation
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0229671
Beschrijving
Analyte
Datatype
integer
Alias
- UMLS CUI [1]
- C0443354
Beschrijving
laboratory Result
Datatype
text
Alias
- UMLS CUI [1]
- C0587081
Beschrijving
Unit laboratory result
Datatype
text
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
Clinical significant result
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0456984
- UMLS CUI [1,2]
- C0750502
Beschrijving
Urinalysis
Alias
- UMLS CUI-1
- C0042014
Beschrijving
Dip stick analysis
Alias
- UMLS CUI-1
- C1160927
Beschrijving
pH urine
Datatype
float
Alias
- UMLS CUI [1]
- C0042044
Beschrijving
If positive for blood or protein, please perform microscopic analysis
Datatype
text
Alias
- UMLS CUI [1]
- C0430371
Beschrijving
Urine glucose
Datatype
text
Alias
- UMLS CUI [1]
- C0430376
Beschrijving
Urine bilirubin
Datatype
text
Alias
- UMLS CUI [1]
- C0430374
Beschrijving
If positive for blood or protein, please perform microscopic analysis
Datatype
text
Alias
- UMLS CUI [1]
- C0430372
Beschrijving
If positive for blood or protein, please perform microscopic analysis
Datatype
boolean
Alias
- UMLS CUI [1]
- C0430397
Beschrijving
Microscopic analysis
Alias
- UMLS CUI-1
- C0430397
Beschrijving
erythrocytes urine
Datatype
integer
Maateenheden
- cells per field
Alias
- UMLS CUI [1]
- C2188659
Beschrijving
Leukocytes urine
Datatype
integer
Maateenheden
- cells per field
Alias
- UMLS CUI [1]
- C1254740
Beschrijving
Bacteria urine
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1262012
- UMLS CUI [1,2]
- C0004618
Beschrijving
epithelia urine
Datatype
integer
Alias
- UMLS CUI [1,1]
- C3828199
- UMLS CUI [1,2]
- C1273342
Beschrijving
salts urine
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C0036140
Beschrijving
Urine cast
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C0151990
Beschrijving
Microscopic urinalysis other
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C0205394
Beschrijving
Overall urinalysis assessment
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C1274040
Beschrijving
Study Completion Part A
Alias
- UMLS CUI-1
- C2826970
Beschrijving
Study completion status
Datatype
integer
Alias
- UMLS CUI [1]
- C2348577
Beschrijving
Reason for non completion
Datatype
integer
Alias
- UMLS CUI [1]
- C1709849
Beschrijving
Specify subjects request for study discontinuation
Datatype
text
Alias
- UMLS CUI [1,1]
- C0332153
- UMLS CUI [1,2]
- C0457454
- UMLS CUI [1,3]
- C1521902
Beschrijving
Specify non-compliance
Datatype
text
Alias
- UMLS CUI [1,1]
- C0457432
- UMLS CUI [1,2]
- C0457454
- UMLS CUI [1,3]
- C1521902
Beschrijving
Specify investigator's judgement
Datatype
text
Alias
- UMLS CUI [1,1]
- C0008961
- UMLS CUI [1,2]
- C0457454
- UMLS CUI [1,3]
- C1521902
Beschrijving
Specify protocol violation
Datatype
text
Alias
- UMLS CUI [1,1]
- C1709750
- UMLS CUI [1,2]
- C1521902
Beschrijving
Specify other reason for study discontinuation
Datatype
text
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C3840932
- UMLS CUI [1,3]
- C1521902
Beschrijving
Study Completion Part B
Alias
- UMLS CUI-1
- C2826970
Beschrijving
Study completion status
Datatype
integer
Alias
- UMLS CUI [1]
- C2348577
Beschrijving
Reason for non completion
Datatype
integer
Alias
- UMLS CUI [1]
- C1709849
Beschrijving
Specify subjects request for study discontinuation
Datatype
text
Alias
- UMLS CUI [1,1]
- C0332153
- UMLS CUI [1,2]
- C0457454
- UMLS CUI [1,3]
- C1521902
Beschrijving
Specify non-compliance
Datatype
text
Alias
- UMLS CUI [1,1]
- C0457432
- UMLS CUI [1,2]
- C0457454
- UMLS CUI [1,3]
- C1521902
Beschrijving
Specify investigator's judgement
Datatype
text
Alias
- UMLS CUI [1,1]
- C0008961
- UMLS CUI [1,2]
- C0457454
- UMLS CUI [1,3]
- C1521902
Beschrijving
Specify protocol violation
Datatype
text
Alias
- UMLS CUI [1,1]
- C1709750
- UMLS CUI [1,2]
- C1521902
Beschrijving
Specify other reason for study discontinuation
Datatype
text
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C3840932
- UMLS CUI [1,3]
- C1521902
Beschrijving
Investigator signature
Alias
- UMLS CUI-1
- C2346576
Beschrijving
Investigator signature
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
Investigator name
Datatype
text
Alias
- UMLS CUI [1]
- C2826892
Beschrijving
Date of investigator signature
Datatype
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
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Follow-up - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164
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C0036140 (UMLS CUI [1,2])
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C1521902 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,2])
C3840932 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])