ID

40875

Description

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

Keywords

Versions (1)
  1. 5/29/20 5/29/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

May 29, 2020

DOI

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License

Creative Commons BY-NC 4.0
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Effect of ropinirole on cardiac conduction as assessed by 12-lead electrocardiogram (101468/902)

English

Blank Pages

1 forms  
  1. StudyEvent: ODM
    1. Blank Pages
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Dosing Details
Description

Dosing Details

Alias
UMLS CUI-1
C0678766
UMLS CUI-2
C1522508
Study Time
Description

Study Time

Data type

text

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0040223
Dosing Details - Date
Description

Dosing Details - Date

Data type

date

Alias
UMLS CUI [1,1]
C0678766
UMLS CUI [1,2]
C1522508
UMLS CUI [1,3]
C0011008
Dosing Details - Actual Time
Description

Dosing Details - Actual Time

Data type

time

Alias
UMLS CUI [1,1]
C0678766
UMLS CUI [1,2]
C1522508
Dose checked and administered by:
Description

Dose checked and administered by:

Data type

text

Alias
UMLS CUI [1,1]
C1283174
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C2348343
Dose checked and witnessed by:
Description

Dose checked and witnessed by:

Data type

text

Alias
UMLS CUI [1,1]
C1283174
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0682356
UMLS CUI [1,4]
C0178602
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Vital Signs - Study Time
Description

Vital Signs - Study Time

Data type

text

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0040223
Vital Signs - Date and Time
Description

Vital Signs - Date and Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Supine systolic blood pressure
Description

Supine systolic blood pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
mm[Hg]
Supine diastolic blood pressure
Description

Supine diastolic blood pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
mm[Hg]
Supine heart rate
Description

Supine heart rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0038846
beats/min
Vital Signs Time
Description

Vital Signs Time

Data type

time

Alias
UMLS CUI [1]
C2826762
Erect systolic blood pressure
Description

Erect systolic blood pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0522014
UMLS CUI [1,2]
C0871470
mm[Hg]
Erect diastolic blood pressure
Description

Erect diastolic blood pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0522014
UMLS CUI [1,2]
C0428883
mm[Hg]
Erect heart rate
Description

Erect heart rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1,1]
C0522014
UMLS CUI [1,2]
C0018810
beats/min
Research Physician’s Signature:
Description

Research Physician’s Signature:

Alias
UMLS CUI-1
C1519316
UMLS CUI-2
C0031831
Research Physician’s Signature
Description

Research Physician’s Signature

Data type

text

Alias
UMLS CUI [1,1]
C1519316
UMLS CUI [1,2]
C0031831
Research Physician’s Signature date
Description

Research Physician’s Signature date

Data type

date

Alias
UMLS CUI [1,1]
C1519316
UMLS CUI [1,2]
C0031831
UMLS CUI [1,3]
C0011008
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Similar models

Blank Pages

1 forms
  1. StudyEvent: ODM
    1. Blank Pages
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item Group
Dosing Details
C0678766 (UMLS CUI-1)
C1522508 (UMLS CUI-2)
Study Time
Item
Study Time
text
C2348563 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Dosing Details - Date
Item
Dosing Details - Date
date
C0678766 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Dosing Details - Actual Time
Item
Dosing Details - Actual Time
time
C0678766 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
Dose checked and administered by:
Item
Dose checked and administered by:
text
C1283174 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C2348343 (UMLS CUI [1,3])
Dose checked and witnessed by:
Item
Dose checked and witnessed by:
text
C1283174 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0682356 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,4])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Vital Signs - Study Time
Item
Vital Signs - Study Time
text
C2348563 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Vital Signs - Date and Time
Item
Vital Signs - Date and Time
datetime
C0518766 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Supine systolic blood pressure
Item
Supine systolic blood pressure
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Supine diastolic blood pressure
Item
Supine diastolic blood pressure
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Supine heart rate
Item
Supine heart rate
integer
C0018810 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Vital Signs Time
Item
Vital Signs Time
time
C2826762 (UMLS CUI [1])
Erect systolic blood pressure
Item
Erect systolic blood pressure
integer
C0522014 (UMLS CUI [1,1])
C0871470 (UMLS CUI [1,2])
Erect diastolic blood pressure
Item
Erect diastolic blood pressure
integer
C0522014 (UMLS CUI [1,1])
C0428883 (UMLS CUI [1,2])
Erect heart rate
Item
Erect heart rate
integer
C0522014 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
Item Group
Research Physician’s Signature:
C1519316 (UMLS CUI-1)
C0031831 (UMLS CUI-2)
Research Physician’s Signature
Item
Research Physician’s Signature
text
C1519316 (UMLS CUI [1,1])
C0031831 (UMLS CUI [1,2])
Research Physician’s Signature date
Item
Research Physician’s Signature date
date
C1519316 (UMLS CUI [1,1])
C0031831 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
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