ID
20661
Beschrijving
Documentation Part: Unscheduled 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
Link
https://clinicaltrials.gov/ct2/show/NCT00460148?term=NCT00460148&rank=1
Trefwoorden
Versies (5)
- 09-03-17 09-03-17 -
- 09-03-17 09-03-17 -
- 10-03-17 10-03-17 -
- 13-03-17 13-03-17 -
- 21-04-17 21-04-17 -
Geüploaded op
9 maart 2017
DOI
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Licentie
Creative Commons BY-NC 3.0 Legacy
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Unscheduled Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148
Unscheduled Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148
Beschrijving
Pharmacokinetics - Blood
Alias
- UMLS CUI-1
- C0031328
- UMLS CUI-2
- C0005767
Beschrijving
Date sample taken
Datatype
date
Maateenheden
- YYYY-MM-DD
Alias
- UMLS CUI [1]
- C1302413
Beschrijving
Actual time
Datatype
time
Maateenheden
- Hr : Min
Alias
- UMLS CUI [1]
- C0040223
Beschrijving
Sample taken
Datatype
text
Alias
- UMLS CUI [1]
- C1277698
Beschrijving
Sample Number
Datatype
text
Alias
- UMLS CUI [1]
- C1299222
Beschrijving
Physical Examination
Alias
- UMLS CUI-1
- C0031809
Beschrijving
Date of Assessment
Datatype
date
Maateenheden
- Day Month Year
Alias
- UMLS CUI [1]
- C2985720
Beschrijving
Hair and skin
Datatype
text
Alias
- UMLS CUI [1]
- C0018494
- UMLS CUI [2]
- C0558035
Beschrijving
different findings should be separated by either a (;) or a (/)
Datatype
text
Alias
- UMLS CUI [1]
- C0678257
Beschrijving
Lymph nodes
Datatype
text
Alias
- UMLS CUI [1]
- C0024204
Beschrijving
different findings should be separated by either a (;) or a (/)
Datatype
text
Alias
- UMLS CUI [1]
- C0678257
Beschrijving
Eyes
Datatype
text
Alias
- UMLS CUI [1]
- C0200149
Beschrijving
different findings should be separated by either a (;) or a (/)
Datatype
text
Alias
- UMLS CUI [1]
- C0678257
Beschrijving
Ears, Nose and Throat
Datatype
text
Alias
- UMLS CUI [1]
- C0278350
Beschrijving
different findings should be separated by either a (;) or a (/)
Datatype
text
Alias
- UMLS CUI [1]
- C0678257
Beschrijving
Breasts
Datatype
text
Alias
- UMLS CUI [1]
- C0199850
Beschrijving
different findings should be separated by either a (;) or a (/)
Datatype
text
Alias
- UMLS CUI [1]
- C0678257
Beschrijving
Respiratory
Datatype
text
Alias
- UMLS CUI [1]
- C0599324
Beschrijving
different findings should be separated by either a (;) or a (/)
Datatype
text
Alias
- UMLS CUI [1]
- C0678257
Beschrijving
Cardiovascular
Datatype
text
Alias
- UMLS CUI [1]
- C3854344
Beschrijving
different findings should be separated by either a (;) or a (/)
Datatype
text
Alias
- UMLS CUI [1]
- C0678257
Beschrijving
Abdomen
Datatype
text
Alias
- UMLS CUI [1]
- C0562238
Beschrijving
different findings should be separated by either a (;) or a (/)
Datatype
text
Alias
- UMLS CUI [1]
- C0678257
Beschrijving
Urogenital
Datatype
text
Alias
- UMLS CUI [1]
- C1828035
Beschrijving
different findings should be separated by either a (;) or a (/)
Datatype
text
Alias
- UMLS CUI [1]
- C0678257
Beschrijving
Pelvic
Datatype
text
Alias
- UMLS CUI [1]
- C0200045
Beschrijving
different findings should be separated by either a (;) or a (/)
Datatype
text
Alias
- UMLS CUI [1]
- C0678257
Beschrijving
Rectal
Datatype
text
Alias
- UMLS CUI [1]
- C0199900
Beschrijving
different findings should be separated by either a (;) or a (/)
Datatype
text
Alias
- UMLS CUI [1]
- C0678257
Beschrijving
Musculoskeletal
Datatype
text
Alias
- UMLS CUI [1]
- C0475091
Beschrijving
different findings should be separated by either a (;) or a (/)
Datatype
text
Alias
- UMLS CUI [1]
- C0678257
Beschrijving
Neurological
Datatype
text
Alias
- UMLS CUI [1]
- C0027853
Beschrijving
different findings should be separated by either a (;) or a (/)
Datatype
text
Alias
- UMLS CUI [1]
- C0678257
Beschrijving
Mental Status
Datatype
text
Alias
- UMLS CUI [1]
- C0278060
Beschrijving
different findings should be separated by either a (;) or a (/)
Datatype
text
Alias
- UMLS CUI [1]
- C0678257
Beschrijving
Pregnancy Test (Complete for Female Subjects Only)
Alias
- UMLS CUI-1
- C0032976
Beschrijving
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beschrijving
Date
Datatype
date
Maateenheden
- Day Month Year
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0518766
Beschrijving
Planned Relative Time
Datatype
text
Alias
- UMLS CUI [1]
- C0439564
Beschrijving
Planned Absolute time
Datatype
integer
Maateenheden
- min
Alias
- UMLS CUI [1]
- C1552097
Beschrijving
Actual time
Datatype
time
Maateenheden
- Hr : Min
Alias
- UMLS CUI [1]
- C0040223
Beschrijving
Systolic Blood Pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschrijving
Diastolic Blood Pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschrijving
Subject position
Datatype
text
Alias
- UMLS CUI [1]
- C1262869
Beschrijving
Heart Rate
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
12-Lead ECG
Alias
- UMLS CUI-1
- C0430456
Beschrijving
Start date of ECG
Datatype
date
Maateenheden
- Day Month Year
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0013798
Beschrijving
Planned Relative Time
Datatype
text
Alias
- UMLS CUI [1]
- C0439564
Beschrijving
Start Time of ECG
Datatype
time
Maateenheden
- Hr : Min
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C0013798
Beschrijving
Ventricular Rate
Datatype
integer
Maateenheden
- Beats/min
Alias
- UMLS CUI [1]
- C2189285
Beschrijving
PR Interval
Datatype
integer
Maateenheden
- msec
Alias
- UMLS CUI [1]
- C0429087
Beschrijving
QRS Duration
Datatype
integer
Maateenheden
- msec
Alias
- UMLS CUI [1]
- C0429025
Beschrijving
Uncorrected QT Interval
Datatype
integer
Maateenheden
- msec
Alias
- UMLS CUI [1]
- C1287082
Beschrijving
QTc interval
Datatype
integer
Maateenheden
- msec
Alias
- UMLS CUI [1]
- C0489625
Beschrijving
Enter Code for result from following list: 1=Normal 2=Abnormal - not clinically significant 3=Abnormal - clinically significant 4=No result (not available)
Datatype
integer
Alias
- UMLS CUI [1]
- C0438154
Beschrijving
Local laboratory result data (Haematology)
Alias
- UMLS CUI-1
- C1254595
- UMLS CUI-2
- C0474523
Beschrijving
Date and time sample taken
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C0200345
Beschrijving
Laboratory name
Datatype
text
Alias
- UMLS CUI [1]
- C1882331
Beschrijving
Address
Datatype
text
Alias
- UMLS CUI [1,1]
- C1442065
- UMLS CUI [1,2]
- C0022877
Beschrijving
Has the subject fasted?
Datatype
text
Alias
- UMLS CUI [1]
- C0015663
Beschrijving
Haemoglobin (Hb)
Datatype
float
Alias
- UMLS CUI [1]
- C0518015
Beschrijving
Haematocrit
Datatype
float
Alias
- UMLS CUI [1]
- C0018935
Beschrijving
Mean cell haemoglobin (MCH)
Datatype
float
Alias
- UMLS CUI [1]
- C0369183
Beschrijving
Red blood cell count (RBC)
Datatype
float
Alias
- UMLS CUI [1]
- C0014772
Beschrijving
White blood cell count (WBC)
Datatype
float
Alias
- UMLS CUI [1]
- C0023508
Beschrijving
Platelets
Datatype
float
Alias
- UMLS CUI [1]
- C0032181
Beschrijving
Lymphocytes
Datatype
float
Alias
- UMLS CUI [1]
- C0200635
Beschrijving
Neutrophils
Datatype
float
Alias
- UMLS CUI [1]
- C0200633
Beschrijving
Monocytes
Datatype
float
Alias
- UMLS CUI [1]
- C0200637
Beschrijving
Basophils
Datatype
float
Alias
- UMLS CUI [1]
- C0200641
Beschrijving
Eosinophils
Datatype
float
Alias
- UMLS CUI [1]
- C0200638
Beschrijving
Units for differential
Datatype
text
Alias
- UMLS CUI [1,1]
- C1820731
- UMLS CUI [1,2]
- C1519795
Beschrijving
Local laboratory result data - (Clinical Chemistry)
Alias
- UMLS CUI-1
- C1254595
- UMLS CUI-2
- C0525044
Beschrijving
Date and time sample taken
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C0200345
Beschrijving
Laboratory name
Datatype
text
Alias
- UMLS CUI [1]
- C1882331
Beschrijving
Address
Datatype
text
Alias
- UMLS CUI [1,1]
- C1442065
- UMLS CUI [1,2]
- C0022877
Beschrijving
Has the subject fasted?
Datatype
text
Alias
- UMLS CUI [1]
- C0015663
Beschrijving
Sodium
Datatype
float
Alias
- UMLS CUI [1]
- C0337443
Beschrijving
Potassium
Datatype
float
Alias
- UMLS CUI [1]
- C0202194
Beschrijving
Urea
Datatype
float
Alias
- UMLS CUI [1]
- C0523961
Beschrijving
Creatinine
Datatype
float
Alias
- UMLS CUI [1]
- C0201976
Beschrijving
Total protein
Datatype
float
Alias
- UMLS CUI [1]
- C0555903
Beschrijving
Albumin
Datatype
float
Alias
- UMLS CUI [1]
- C0201838
Beschrijving
Total bilirubin
Datatype
float
Alias
- UMLS CUI [1]
- C0201913
Beschrijving
Aspartate aminotransferase (AST)
Datatype
float
Alias
- UMLS CUI [1]
- C0201899
Beschrijving
Alanine aminotransferase (ALT)
Datatype
float
Alias
- UMLS CUI [1]
- C0201836
Beschrijving
Alkaline phosphatase (AP)
Datatype
float
Alias
- UMLS CUI [1]
- C0201850
Beschrijving
Gamma glutamyl transferase (GGT)
Datatype
float
Alias
- UMLS CUI [1]
- C0202035
Beschrijving
Calcium
Datatype
float
Alias
- UMLS CUI [1]
- C0201925
Beschrijving
Phosphate
Datatype
float
Alias
- UMLS CUI [1]
- C0523826
Beschrijving
Cholesterol
Datatype
float
Alias
- UMLS CUI [1]
- C1445957
Beschrijving
Triglycerides
Datatype
float
Alias
- UMLS CUI [1]
- C0202236
Beschrijving
Glucose
Datatype
float
Alias
- UMLS CUI [1]
- C0202042
Beschrijving
Creatine phosphokinase
Datatype
float
Alias
- UMLS CUI [1]
- C0201973
Beschrijving
Chloride
Datatype
text
Alias
- UMLS CUI [1]
- C0201952
Beschrijving
Urinalysis
Alias
- UMLS CUI-1
- C0042014
Beschrijving
Date and time sample taken
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C0200345
Beschrijving
Laboratory name
Datatype
text
Alias
- UMLS CUI [1]
- C1882331
Beschrijving
Address
Datatype
text
Alias
- UMLS CUI [1,1]
- C1442065
- UMLS CUI [1,2]
- C0022877
Beschrijving
Urinalysis (Dipstick) Test: pH
Datatype
text
Alias
- UMLS CUI [1]
- C0042044
Beschrijving
Urinalysis (Dipstick) Test: Protein
Datatype
text
Alias
- UMLS CUI [1]
- C0262923
Beschrijving
Urinalysis (Dipstick) Test: Glucose
Datatype
text
Alias
- UMLS CUI [1]
- C0004076
Beschrijving
Urinalysis (Dipstick) Test: Bilirubin
Datatype
text
Alias
- UMLS CUI [1]
- C0042040
Beschrijving
Urinalysis (Dipstick) Test: Blood
Datatype
text
Alias
- UMLS CUI [1]
- C0202514
Beschrijving
Urinalysis (Dipstick) Test: Specific Gravity
Datatype
text
Alias
- UMLS CUI [1]
- C0430383
Beschrijving
Note: Sedimentary microscopy should only be performed if any of the dipstick results are abnormal.
Datatype
text
Alias
- UMLS CUI [1]
- C2700128
Beschrijving
Urinalysis (Microscopy) Test: White blood cells
Datatype
text
Alias
- UMLS CUI [1]
- C0919738
Beschrijving
Urinalysis (Microscopy) Test: Red blood cells
Datatype
text
Alias
- UMLS CUI [1]
- C0221752
Beschrijving
Urinalysis (Microscopy) Test: Hyaline casts
Datatype
text
Alias
- UMLS CUI [1]
- C1254537
Beschrijving
Urinalysis (Microscopy) Test: Granular casts
Datatype
text
Alias
- UMLS CUI [1]
- C2697521
Beschrijving
Urinalysis (Microscopy) Test: Cellular casts
Datatype
text
Alias
- UMLS CUI [1]
- C2699157
Beschrijving
12-Lead ECG Abnormalities
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C1704258
Similar models
Unscheduled Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148
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C0518766 (UMLS CUI [1,2])
C0013798 (UMLS CUI [1,2])
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C0200345 (UMLS CUI [1,3])
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