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Information:
Fel:
ID
24908
Beskrivning
Study ID: 101468/166 Clinical Study ID: SKF-101468/166 Study Title: A Phase II, randomised, double-blind, active-controlled, dose-escalation study to determine the maximum well-tolerated starting dose of a new formulation of ropinirole in Parkinson's Disease patients not receiving other dopaminergic therapies Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Parkinson Disease
Nyckelord
Versioner (4)
- 2017-08-22 2017-08-22 -
- 2017-08-23 2017-08-23 -
- 2017-09-04 2017-09-04 -
- 2017-09-04 2017-09-04 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
22 augusti 2017
DOI
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Licens
Creative Commons BY-NC 3.0
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serial vital signs & pharmacokinetic sampling determination of the maximum well-tolerated starting dose of ropinirole in Parkinson's Disease 101468/166
serial vital signs & pharmacokinetic sampling determination of the maximum well-tolerated starting dose of ropinirole in Parkinson's Disease 101468/166
Similar models
serial vital signs & pharmacokinetic sampling determination of the maximum well-tolerated starting dose of ropinirole in Parkinson's Disease 101468/166
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
patient's initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
patient number
Item
Patient No.
integer
C1830427 (UMLS CUI [1])
date sample taken
Item
Date plasma samples drawn
date
C1302413 (UMLS CUI [1])
Item Group
Sample 01: Specified Time Pre-Dose
C0518766 (UMLS CUI-1)
C0439565 (UMLS CUI-2)
C0439565 (UMLS CUI-2)
time of plasma sample
Item
Actual Time of Plasma Sample
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
heart rate in supine position
Item
Supine Heart Rate
integer
C3262833 (UMLS CUI [1])
heart rate in standing position
Item
Standing Heart Rate
integer
C2029905 (UMLS CUI [1])
blood pressure in supine position
Item
Supine Blood Pressure
integer
C0005823 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
blood pressure in standing position
Item
Standing Blood Pressure
integer
C0580945 (UMLS CUI [1])
Item Group
Sample 02: 1 hr Post-Dose
C0518766 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
C0439568 (UMLS CUI-2)
time of plasma sample
Item
Actual Time of Plasma Sample
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
heart rate in supine position
Item
Supine Heart Rate
integer
C3262833 (UMLS CUI [1])
heart rate in standing position
Item
Standing Heart Rate
integer
C2029905 (UMLS CUI [1])
blood pressure in supine position
Item
Supine Blood Pressure
integer
C0005823 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
blood pressure in standing position
Item
Standing Blood Pressure
integer
C0580945 (UMLS CUI [1])
Item Group
Sample 03: 2 hrs Post-Dose
C0518766 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
C0439568 (UMLS CUI-2)
time of plasma sample
Item
Actual Time of Plasma Sample
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
heart rate in supine position
Item
Supine Heart Rate
integer
C3262833 (UMLS CUI [1])
heart rate in standing position
Item
Standing Heart Rate
integer
C2029905 (UMLS CUI [1])
blood pressure in supine position
Item
Supine Blood Pressure
integer
C0005823 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
blood pressure in standing position
Item
Standing Blood Pressure
integer
C0580945 (UMLS CUI [1])
Item Group
Sample 04: 4 hrs Post-Dose
C0518766 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
C0439568 (UMLS CUI-2)
time of plasma sample
Item
Actual Time of Plasma Sample
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
heart rate in supine position
Item
Supine Heart Rate
integer
C3262833 (UMLS CUI [1])
heart rate in standing position
Item
Standing Heart Rate
integer
C2029905 (UMLS CUI [1])
blood pressure in supine position
Item
Supine Blood Pressure
integer
C0005823 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
blood pressure in standing position
Item
Standing Blood Pressure
integer
C0580945 (UMLS CUI [1])
Item Group
Sample 05: 6 hrs Post-Dose
C0518766 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
C0439568 (UMLS CUI-2)
time of plasma sample
Item
Actual Time of Plasma Sample
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
heart rate in supine position
Item
Supine Heart Rate
integer
C3262833 (UMLS CUI [1])
heart rate in standing position
Item
Standing Heart Rate
integer
C2029905 (UMLS CUI [1])
blood pressure in supine position
Item
Supine Blood Pressure
integer
C0005823 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
blood pressure in standing position
Item
Standing Blood Pressure
integer
C0580945 (UMLS CUI [1])
Item Group
Sample 06: 8 hrs Post-Dose
C0518766 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
C0439568 (UMLS CUI-2)
time of plasma sample
Item
Actual Time of Plasma Sample
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
heart rate in supine position
Item
Supine Heart Rate
integer
C3262833 (UMLS CUI [1])
heart rate in standing position
Item
Standing Heart Rate
integer
C2029905 (UMLS CUI [1])
blood pressure in supine position
Item
Supine Blood Pressure
integer
C0005823 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
blood pressure in standing position
Item
Standing Blood Pressure
integer
C0580945 (UMLS CUI [1])
Item Group
Sample 07: 10 hrs Post-Dose
C0518766 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
C0439568 (UMLS CUI-2)
time of plasma sample
Item
Actual Time of Plasma Sample
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
heart rate in supine position
Item
Supine Heart Rate
integer
C3262833 (UMLS CUI [1])