ID
21089
Beschreibung
Documentation Part: Treatment Phase Day 1 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
Stichworte
Versionen (4)
- 03.03.17 03.03.17 -
- 04.03.17 04.03.17 -
- 08.03.17 08.03.17 -
- 10.04.17 10.04.17 -
Hochgeladen am
10. April 2017
DOI
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Lizenz
Creative Commons BY-NC 3.0
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Treatment Phase Day 1 Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148
Treatment Phase Day 1 Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148
Beschreibung
Visit date
Alias
- UMLS CUI-1
- C1320303
Beschreibung
Urine drug screen
Alias
- UMLS CUI-1
- C0202274
Beschreibung
Date and time of sample taken
Datentyp
datetime
Alias
- UMLS CUI [1]
- C0011008
- UMLS CUI [2]
- C0040223
Beschreibung
Amphetamines
Datentyp
text
Alias
- UMLS CUI [1]
- C0002667
Beschreibung
Barbiturates
Datentyp
text
Alias
- UMLS CUI [1]
- C0004745
Beschreibung
Cannabis
Datentyp
text
Alias
- UMLS CUI [1]
- C0936079
Beschreibung
Cocaine
Datentyp
text
Alias
- UMLS CUI [1]
- C0009170
Beschreibung
Alcohol test
Alias
- UMLS CUI-1
- C0868676
Beschreibung
Pregnancy test (Complete for Female Subjects of Child-bearing Potential Only)
Alias
- UMLS CUI-1
- C0032976
Beschreibung
Vital signs
Alias
- UMLS CUI-1
- C0518766
Beschreibung
Date
Datentyp
date
Maßeinheiten
- Day Month Year
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0011008
Beschreibung
Planned Relative Time
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0439564
Beschreibung
Planned Absolute time
Datentyp
integer
Maßeinheiten
- min
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C1552097
Beschreibung
Actual time
Datentyp
time
Maßeinheiten
- Hr : Min
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0040223
Beschreibung
Systolic Blood Pressure
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0871470
Beschreibung
Diastolic Blood Pressure
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0428883
Beschreibung
Subject position
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C1262869
Beschreibung
Heart Rate
Datentyp
integer
Maßeinheiten
- beats/min
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0018810
Beschreibung
12-Lead-ECG
Alias
- UMLS CUI-1
- C0430456
Beschreibung
Start date of ECG
Datentyp
date
Maßeinheiten
- Day Month Year
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0013798
Beschreibung
Planned Relative Time
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0439564
Beschreibung
Start Time of ECG
Datentyp
time
Maßeinheiten
- Hr : Min
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C0013798
Beschreibung
Ventricular Rate
Datentyp
integer
Maßeinheiten
- Beats/min
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C2189285
Beschreibung
PR Interval
Datentyp
integer
Maßeinheiten
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429087
Beschreibung
QRS Duration
Datentyp
integer
Maßeinheiten
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429025
Beschreibung
Uncorrected QT Interval
Datentyp
integer
Maßeinheiten
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1287082
Beschreibung
QTc Invertal
Datentyp
integer
Maßeinheiten
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0860814
Beschreibung
Enter code for result from the following list: 1=Normal 2=Abnormal - not clinically significant 3=Abnormal - clinically significant 4=No result (not available)
Datentyp
integer
Alias
- UMLS CUI [1]
- C0438154
Beschreibung
Randomisation number
Alias
- UMLS CUI-1
- C0034656
- UMLS CUI-2
- C0237753
Beschreibung
Record randomisation number
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
Beschreibung
Date of randomisation
Datentyp
date
Maßeinheiten
- Day Month Year
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0011008
Beschreibung
Time of randomisation
Datentyp
time
Maßeinheiten
- Hr : Min
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0040223
Beschreibung
Invesatigational product
Alias
- UMLS CUI-1
- C3898691
Beschreibung
Planned timepoint
Datentyp
text
Alias
- UMLS CUI [1]
- C2348792
Beschreibung
Date of dose
Datentyp
date
Maßeinheiten
- Day Month Year
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0011008
Beschreibung
Time of dose
Datentyp
time
Maßeinheiten
- Hr : Min
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0040223
Beschreibung
Treatment confirmation
Alias
- UMLS CUI-1
- C0750484
- UMLS CUI-2
- C0087111
Beschreibung
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0750484
- UMLS CUI [1,2]
- C0087111
Beschreibung
If No, record reason(s)
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0750484
- UMLS CUI [1,3]
- C0087111
Beschreibung
Ambulatory blood pressure monitoring
Alias
- UMLS CUI-1
- C0026426
- UMLS CUI-2
- C0439841
Beschreibung
Start date
Datentyp
date
Maßeinheiten
- Day Month Year
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0026426
- UMLS CUI [1,3]
- C0439841
Beschreibung
Start time
Datentyp
time
Maßeinheiten
- Hr : Min
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C0026426
- UMLS CUI [1,3]
- C0439841
Beschreibung
Stop time
Datentyp
time
Maßeinheiten
- Hr : Min
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C0026426
- UMLS CUI [1,3]
- C0439841
Ähnliche Modelle
Treatment Phase Day 1 Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148
C0040223 (UMLS CUI [2])
C0868676 (UMLS CUI [1,2])
C0032976 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,2])
C1552097 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0871470 (UMLS CUI [1,2])
C0428883 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
C0013798 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,2])
C0013798 (UMLS CUI [1,2])
C2189285 (UMLS CUI [1,2])
C0429087 (UMLS CUI [1,2])
C0429025 (UMLS CUI [1,2])
C1287082 (UMLS CUI [1,2])
C0860814 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0087111 (UMLS CUI-2)
C0087111 (UMLS CUI [1,2])
C0750484 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0439841 (UMLS CUI-2)
C0026426 (UMLS CUI [1,2])
C0439841 (UMLS CUI [1,3])
C0026426 (UMLS CUI [1,2])
C0439841 (UMLS CUI [1,3])
C0026426 (UMLS CUI [1,2])
C0439841 (UMLS CUI [1,3])