ID

25704

Description

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

Keywords

  1. 9/11/17 9/11/17 -
  2. 9/11/17 9/11/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 11, 2017

DOI

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License

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

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

Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Focus Panel ID
Description

focus panel

Data type

integer

Alias
UMLS CUI [1]
C3846158
Patient No
Description

patient number

Data type

integer

Alias
UMLS CUI [1]
C1830427
Date
Description

date

Data type

date

Alias
UMLS CUI [1]
C0011008
Number of Visit
Description

visit number

Data type

text

Alias
UMLS CUI [1]
C1549755
Treatment
Description

treatment

Data type

text

Alias
UMLS CUI [1]
C0087111
Cardiovascular Monitoring
Description

Cardiovascular Monitoring

Alias
UMLS CUI-1
C0007226
Time relative to dosing
Description

time relative to dosing

Data type

text

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

actual time

Data type

time

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

blood pressure systolic in semi-supine position

Data type

integer

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

blood pressure diastolic in semi-supine position

Data type

integer

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

heart rate in semi-supine position

Data type

integer

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

actual time

Data type

time

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

blood pressure systolic standing

Data type

integer

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

blood pressure diastolic ins standing position

Data type

integer

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

heart rate in standing position

Data type

integer

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

Comments

Alias
UMLS CUI-1
C0947611
Comments
Description

comments

Data type

text

Alias
UMLS CUI [1]
C0947611

Similar models

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

Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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])
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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