ID

25480

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

Versions (2)
  1. 9/4/17 9/4/17 -
  2. 9/12/17 9/12/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 4, 2017

DOI

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License

Creative Commons BY-NC 3.0
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screening & final examination electrocardiography PK and tolerability of ropinirole as 5 new formulations 101468/197

English

screening & final examination electrocardiography PK and tolerability of ropinirole as 5 new formulations 101468/197

1 forms  
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
Treatment
Description

Only fulfill this item for "final examination".

Data type

text

Alias
UMLS CUI [1]
C0087111
12-LEAD ECG
Description

12-LEAD ECG

Alias
UMLS CUI-1
C0430456
Time
Description

time

Data type

time

Alias
UMLS CUI [1]
C0040223
HR
Description

heart rate

Data type

integer

Measurement units
  • 1/min
Alias
UMLS CUI [1]
C0018810
1/min
PR
Description

PR-interval

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS
Description

QRS duration

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1]
C1880451
msec
QT
Description

QT interval

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1]
C1880452
msec
QTc
Description

QTc interval

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1]
C0489625
msec
Is the ECG normal?
Description

ECG normal

Data type

text

Alias
UMLS CUI [1]
C0522054
If abnormal, clinically relevant?
Description

ECG abnormal

Data type

text

Alias
UMLS CUI [1]
C0522055
Comments
Description

comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Initials
Description

initials

Data type

text

Alias
UMLS CUI [1]
C2986440
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Similar models

screening & final examination electrocardiography PK and tolerability of ropinirole as 5 new formulations 101468/197

1 forms
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])
treatment
Item
Treatment
text
C0087111 (UMLS CUI [1])
Item Group
12-LEAD ECG
C0430456 (UMLS CUI-1)
time
Item
Time
time
C0040223 (UMLS CUI [1])
heart rate
Item
HR
integer
C0018810 (UMLS CUI [1])
PR-interval
Item
PR
integer
C0429087 (UMLS CUI [1])
QRS duration
Item
QRS
integer
C1880451 (UMLS CUI [1])
QT interval
Item
QT
integer
C1880452 (UMLS CUI [1])
QTc interval
Item
QTc
integer
C0489625 (UMLS CUI [1])
Item
Is the ECG normal?
text
C0522054 (UMLS CUI [1])
ECG normal
Code List
Is the ECG normal?
CL Item
Yes (Yes)
CL Item
No (No)
Item
If abnormal, clinically relevant?
text
C0522055 (UMLS CUI [1])
ECG abnormal
Code List
If abnormal, clinically relevant?
CL Item
Yes (Yes)
CL Item
No (No)
comment
Item
Comments
text
C0947611 (UMLS CUI [1])
initials
Item
Initials
text
C2986440 (UMLS CUI [1])
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