ID

36012

Description

Study ID: 101468/198 Clinical Study ID: 101468/198 Study Title:An open, randomised, crossover, healthy volunteer study to compare the PK and tolerability of ropinirole as 3 different new formulations with the standard marketed formulation and to study the effects of a high fat meal on a new formulation 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: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Restless Legs Syndrome The Study consists of a Screening, 5 Sessions each with 2 days and a Follow-up. This document contains the Electrocardiography/ Cardiovascular Monitoring form. It has to be filled in for screening and follow-up.

Keywords

Versions (1)
  1. 4/9/19 4/9/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

April 9, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198

English

Electrocardiography/ Cardiovascular Monitoring for Screening and Follow-up

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject No.
Description

Subject No.

Data type

text

Alias
UMLS CUI [1]
C2348585
Panel ID
Description

Panel ID

Data type

text

Alias
UMLS CUI [1]
C3846158
Visit date
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C1320303
Visit type
Description

Visit type

Data type

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
12 LEAD ECG
Description

12 LEAD ECG

Alias
UMLS CUI-1
C0430456
ECG Time
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1301880
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
PR interval
Description

PR interval

Data type

integer

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

QRS duration

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1]
C0429025
msec
QT duration
Description

QT duration

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1]
C1880452
msec
QTc interval
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
Comments (Include Clinically Significant ECG Abnormalities)
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
Blood pressure measurement
Description

Blood pressure measurement

Alias
UMLS CUI-1
C0005823
Body position
Description

Body position

Data type

integer

Alias
UMLS CUI [1,1]
C1262869
UMLS CUI [1,2]
C0005823
Time of measurement
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0005823
Systolic blood pressure
Description

Systolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic blood pressure
Description

Diastolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Pulse
Description

Pulse

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0232117
bpm
Comments
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
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Similar models

Electrocardiography/ Cardiovascular Monitoring for Screening and Follow-up

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject No.
Item
Subject No.
text
C2348585 (UMLS CUI [1])
Panel ID
Item
Panel ID
text
C3846158 (UMLS CUI [1])
Visit date
Item
Visit date
date
C1320303 (UMLS CUI [1])
Item
Visit type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Visit type
Code List
Visit type
CL Item
Screening (1)
CL Item
Follow-up (2)
Item Group
12 LEAD ECG
C0430456 (UMLS CUI-1)
ECG Time
Item
ECG Time
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
PR interval
Item
PR interval
integer
C0429087 (UMLS CUI [1])
QRS duration
Item
QRS duration
integer
C0429025 (UMLS CUI [1])
QT duration
Item
QT duration
integer
C1880452 (UMLS CUI [1])
QTc interval
Item
QTc interval
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 (Y)
CL Item
No (N)
Comments
Item
Comments (Include Clinically Significant ECG Abnormalities)
text
C0947611 (UMLS CUI [1])
Item Group
Blood pressure measurement
C0005823 (UMLS CUI-1)
Item
Body position
integer
C1262869 (UMLS CUI [1,1])
C0005823 (UMLS CUI [1,2])
Body position
Code List
Body position
CL Item
semi-supine (1)
CL Item
standing (2)
Time of measurement
Item
Time of measurement
time
C0040223 (UMLS CUI [1,1])
C0005823 (UMLS CUI [1,2])
Systolic blood pressure
Item
Systolic blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
Pulse
Item
Pulse
integer
C0232117 (UMLS CUI [1])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
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