ID

40858

Beschrijving

Study ID: 101468/902 Clinical Study ID: 101468/902 Study Title:A study to evaluate the effect of repeated oral doses of ropinirole on cardiac conduction as assessed by 12-lead electrocardiogram compared to placebo and single oral doses of moxifloxacin (Bayer) as a positive control. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline 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

Trefwoorden

  1. 26-05-20 26-05-20 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

26 mei 2020

DOI

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Licentie

Creative Commons BY-NC 4.0

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Effect of ropinirole on cardiac conduction as assessed by 12-lead electrocardiogram (101468/902)

PK Blood Sampling

  1. StudyEvent: ODM
    1. PK Blood Sampling
Administrative
Beschrijving

Administrative

Alias
UMLS CUI-1
C1320722
Subject Number
Beschrijving

Subject Number

Datatype

text

Alias
UMLS CUI [1]
C2348585
PK Blood Sampling
Beschrijving

PK Blood Sampling

Alias
UMLS CUI-1
C0031327
UMLS CUI-2
C0178913
Time relative to start of dose
Beschrijving

Time relative to start of dose

Datatype

integer

Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C0178602
PK blood sampling - Date
Beschrijving

PK blood sampling - Date

Datatype

date

Alias
UMLS CUI [1,1]
C0031327
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C0011008
PK blood sampling - Actual Time
Beschrijving

PK blood sampling - Actual Time

Datatype

time

Alias
UMLS CUI [1,1]
C0031327
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C0040223
PK blood sampling - Sample Taken
Beschrijving

PK blood sampling - Sample Taken

Datatype

boolean

Alias
UMLS CUI [1,1]
C0031327
UMLS CUI [1,2]
C0178913
PK Blood Sampling - Comments
Beschrijving

PK Blood Sampling - Comments

Datatype

text

Alias
UMLS CUI [1,1]
C0031327
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C0947611

Similar models

PK Blood Sampling

  1. StudyEvent: ODM
    1. PK Blood Sampling
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item Group
PK Blood Sampling
C0031327 (UMLS CUI-1)
C0178913 (UMLS CUI-2)
Item
Time relative to start of dose
integer
C1301880 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Code List
Time relative to start of dose
CL Item
Pre-dose (1)
CL Item
+0.25 hr (2)
CL Item
+0.50 hr (3)
CL Item
+0.75 hr (4)
CL Item
+1 hrs (5)
CL Item
+1.25 hrs (6)
CL Item
+1.5 hrs (7)
CL Item
+2 hrs (8)
CL Item
+3 hrs (9)
CL Item
+4 hrs (10)
CL Item
+6 hrs (11)
CL Item
+8 hrs (12)
CL Item
+16-18 hrs (13)
PK blood sampling - Date
Item
PK blood sampling - Date
date
C0031327 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
PK blood sampling - Actual Time
Item
PK blood sampling - Actual Time
time
C0031327 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
PK blood sampling - Sample Taken
Item
PK blood sampling - Sample Taken
boolean
C0031327 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
PK Blood Sampling - Comments
Item
PK Blood Sampling - Comments
text
C0031327 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])

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