ID

25704

Beskrivning

Study ID: 101468/197 Clinical Study ID: SKF-101468/197 Study Title:An open study to compare the PK and tolerability of ropinirole administered as 5 different new formulations with the standard, marketed formulation in healthy volunteers 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: Requip Study Indication : Restless Legs Syndrome

Nyckelord

Versioner (2)
  1. 2017-09-11 2017-09-11 -
  2. 2017-09-11 2017-09-11 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

11 september 2017

DOI

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Licens

Creative Commons BY-NC 3.0
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visit period 1,2,3 & 4 cardiovascular monitoring day 1 PK and tolerability of ropinirole as 5 new formulations 101468/197

Engelsk

visit period 1,2,3 & 4 cardiovascular monitoring day 1 PK and tolerability of ropinirole as 5 new formulations 101468/197

1 Formulär  
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Focus Panel ID
Beskrivning

focus panel

Datatyp

integer

Alias
UMLS CUI [1]
C3846158
Patient No
Beskrivning

patient number

Datatyp

integer

Alias
UMLS CUI [1]
C1830427
Date
Beskrivning

date

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Number of Visit
Beskrivning

visit number

Datatyp

text

Alias
UMLS CUI [1]
C1549755
Treatment
Beskrivning

treatment

Datatyp

text

Alias
UMLS CUI [1]
C0087111
Cardiovascular Monitoring
Beskrivning

Cardiovascular Monitoring

Alias
UMLS CUI-1
C0007226
Time relative to dosing
Beskrivning

time relative to dosing

Datatyp

text

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C3469597
UMLS CUI [1,3]
C0304229
Actual Time
Beskrivning

actual time

Datatyp

time

Alias
UMLS CUI [1]
C0040223
Semi-supine BP: Systolic
Beskrivning

blood pressure systolic in semi-supine position

Datatyp

integer

Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
Semi-supine BP: Diastolic
Beskrivning

blood pressure diastolic in semi-supine position

Datatyp

integer

Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
Semi-supine Bts/min
Beskrivning

heart rate in semi-supine position

Datatyp

integer

Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0038846
Actual Time
Beskrivning

actual time

Datatyp

time

Alias
UMLS CUI [1]
C0040223
Erect BP: Systolic
Beskrivning

blood pressure systolic standing

Datatyp

integer

Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0231472
Erecet BP: Diastolic
Beskrivning

blood pressure diastolic ins standing position

Datatyp

integer

Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0231472
Erect pulse Bts/min
Beskrivning

heart rate in standing position

Datatyp

integer

Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0231472
Comments
Beskrivning

Comments

Alias
UMLS CUI-1
C0947611
Comments
Beskrivning

comments

Datatyp

text

Alias
UMLS CUI [1]
C0947611
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Similar models

visit period 1,2,3 & 4 cardiovascular monitoring day 1 PK and tolerability of ropinirole as 5 new formulations 101468/197

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
focus panel
Item
Focus Panel ID
integer
C3846158 (UMLS CUI [1])
patient number
Item
Patient No
integer
C1830427 (UMLS CUI [1])
date
Item
Date
date
C0011008 (UMLS CUI [1])
Item
Number of Visit
text
C1549755 (UMLS CUI [1])
visit number
Code List
Number of Visit
CL Item
Period 1 (Period 1)
CL Item
Period 2 (Period 2)
CL Item
Period 3 (Period 3)
CL Item
Period 4 (Period 4)
treatment
Item
Treatment
text
C0087111 (UMLS CUI [1])
Item Group
Cardiovascular Monitoring
C0007226 (UMLS CUI-1)
Item
Time relative to dosing
text
C0439564 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
time relative to dosing
Code List
Time relative to dosing
CL Item
predose (predose)
CL Item
+1hr (+1hr)
CL Item
+2hrs (+2hrs)
CL Item
+3hrs (+3hrs)
CL Item
+4hrs (+4hrs)
CL Item
+5hrs (+5hrs)
CL Item
+6hrs (+6hrs)
CL Item
+8hrs (+8hrs)
CL Item
+12hrs (+12hrs)
actual time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
blood pressure systolic in semi-supine position
Item
Semi-supine BP: Systolic
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
blood pressure diastolic in semi-supine position
Item
Semi-supine BP: Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
heart rate in semi-supine position
Item
Semi-supine Bts/min
integer
C0018810 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
actual time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
blood pressure systolic standing
Item
Erect BP: Systolic
integer
C0871470 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
blood pressure diastolic ins standing position
Item
Erecet BP: Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
heart rate in standing position
Item
Erect pulse Bts/min
integer
C0018810 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
Item Group
Comments
C0947611 (UMLS CUI-1)
comments
Item
Comments
text
C0947611 (UMLS CUI [1])
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