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25461
Beschreibung
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
Stichworte
Versionen (4)
- 22.08.17 22.08.17 -
- 23.08.17 23.08.17 -
- 04.09.17 04.09.17 -
- 04.09.17 04.09.17 -
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4. September 2017
DOI
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visit 2,3 & 4 vital signs & pharmacokinetic sampling starting dose of ropinirole Parkinson's Disease 101468/166
visit 2,3 & 4 vital signs & pharmacokinetic sampling starting dose of ropinirole Parkinson's Disease 101468/166
Ähnliche Modelle
visit 2,3 & 4 vital signs & pharmacokinetic sampling starting dose of ropinirole Parkinson's Disease 101468/166
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
patient's initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
patient number
Item
Patient No.
integer
C1830427 (UMLS CUI [1])
Item Group
Sample 02: 1 hr Post-Dose Study Period Visit 2 (Day 1)
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 Study Period Visit 2 (Day 1)
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 Study Period Visit 2 (Day 1)
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 Study Period Visit 2 (Day 1)
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 Study Period Visit 2 (Day 1)
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 Study Period Visit 2 (Day 1)
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 08: 12 hrs Post-Dose Study Period Visit 2 (Day 1)
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 09: 14 hrs Post-Dose Study Period Visit 2 (Day 1)
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])
Item Group
Sample 10: 16 hrs Post-Dose Study Period Visit 2 (Day 1)
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])
Item Group
Sample 11: 20 hrs Post-Dose Study Period Visit 2 (Day 1)
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])
Item Group
Sample 12: 24 hrs Post-Dose Study Period Visit 2 (Day 1)
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])
date sample taken
Item
Date plasma samples drawn
date
C1302413 (UMLS CUI [1])
Item Group
Sample 01: Specified Time Pre-Dose Study Period Visit 3 (Day 4)
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
Deviations Study Period Visit 3 (Day 4)
C0033213 (UMLS CUI-1)
C0005834 (UMLS CUI-2)
C0005834 (UMLS CUI-2)
Item
Were there any important deviations from the scheduled sampling?
integer
C0033213 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,2])
Code List
Were there any important deviations from the scheduled sampling?
CL Item
Yes (1)
CL Item
No (2)
deviations in blood sample taking
Item
Were there any important deviations from the scheduled sampling?
text
C0033213 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,2])
shipping date of blood samples
Item
Shipping date of blood samples
date
C0370003 (UMLS CUI [1,1])
C1524049 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1524049 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Samples were collected and processed as per protocol?
integer
C0200345 (UMLS CUI [1,1])
C1507394 (UMLS CUI [1,2])
C1507394 (UMLS CUI [1,2])
CL Item
Yes (1)
CL Item
No (2)
date sample taken
Item
Date plasma samples drawn
date
C1302413 (UMLS CUI [1])
Item Group
Sample 01: Specified Time Pre-Dose Study Period Visit 4 (Day 8)
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
Deviations Study Period Visit 4 (Day 8)
C0033213 (UMLS CUI-1)
C0005834 (UMLS CUI-2)
C0005834 (UMLS CUI-2)
Item
Were there any important deviations from the scheduled sampling?
integer
C0033213 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,2])
Code List
Were there any important deviations from the scheduled sampling?
CL Item
Yes (1)
CL Item
No (2)
deviations in blood sample taking
Item
Were there any important deviations from the scheduled sampling?
text
C0033213 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,2])
shipping date of blood samples
Item
Shipping date of blood samples
date
C0370003 (UMLS CUI [1,1])
C1524049 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1524049 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Samples were collected and processed as per protocol?
integer
C0200345 (UMLS CUI [1,1])
C1507394 (UMLS CUI [1,2])
C1507394 (UMLS CUI [1,2])
CL Item
Yes (1)
CL Item
No (2)