ID

36013

Beskrivning

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 form. It has to be filled in for all Sessions each for both Day 1 and Day 2.

Nyckelord

Versioner (1)
  1. 2019-04-09 2019-04-09 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

9 april 2019

DOI

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Licens

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

Engelsk

Electrocardiography

1 Formulär  
  1. StudyEvent: ODM
    1. Electrocardiography
Administrative data
Beskrivning

Administrative data

Alias
UMLS CUI-1
C1320722
Subject No.
Beskrivning

Subject No.

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Panel ID
Beskrivning

Panel ID

Datatyp

text

Alias
UMLS CUI [1]
C3846158
Visit type
Beskrivning

Visit type

Datatyp

integer

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

12 LEAD ECG

Alias
UMLS CUI-1
C0430456
Planned relative time, Day 1
Beskrivning

Only for Day 1.

Datatyp

integer

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C1623258
Planned relative time, Day 2
Beskrivning

Only for Day 2.

Datatyp

integer

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C1623258
ECG Time
Beskrivning

00:00-23:59

Datatyp

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1301880
heart rate
Beskrivning

heart rate

Datatyp

integer

Måttenheter
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
PR interval
Beskrivning

PR interval

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS duration
Beskrivning

QRS duration

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0429025
msec
QT duration
Beskrivning

QT duration

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1]
C1880452
msec
QTc interval
Beskrivning

QTc interval

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0489625
msec
Is the ECG normal?
Beskrivning

ECG normal

Datatyp

text

Alias
UMLS CUI [1]
C0522054
Comments (Include Clinically Significant ECG Abnormalities)
Beskrivning

Comments

Datatyp

text

Alias
UMLS CUI [1]
C0947611
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Similar models

Electrocardiography

1 Formulär
  1. StudyEvent: ODM
    1. Electrocardiography
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Item
Visit type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Visit type
Code List
Visit type
CL Item
Session 1 day 1 (1)
CL Item
Session 1 day 2 (2)
CL Item
Session 2 day 1  (3)
CL Item
Session 2 day 2 (4)
CL Item
Session 3 day 1 (5)
CL Item
Session 3 day 2 (6)
CL Item
Session 4 day 1 (7)
CL Item
Session 4 day 2 (8)
CL Item
Session 5 day 1 (9)
CL Item
Session 5 day 2 (10)
Item Group
12 LEAD ECG
C0430456 (UMLS CUI-1)
Item
Planned relative time, Day 1
integer
C0439564 (UMLS CUI [1,1])
C1623258 (UMLS CUI [1,2])
Planned relative time, Day 1
Code List
Planned relative time, Day 1
CL Item
predose (1)
CL Item
+1h (2)
CL Item
+2h (3)
CL Item
+3h (4)
CL Item
+4h (5)
CL Item
+5h (6)
CL Item
+6h (7)
Item
Planned relative time, Day 2
integer
C0439564 (UMLS CUI [1,1])
C1623258 (UMLS CUI [1,2])
Planned relative time, Day 1
Code List
Planned relative time, Day 2
CL Item
+16h (1)
CL Item
+24h (2)
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])
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