ID

40857

Descripción

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

Palabras clave

Versiones (2)
  1. 26/5/20 26/5/20 -
  2. 26/5/20 26/5/20 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

26 de mayo de 2020

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

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

Inglés

Vital Signs

1 formularios  
  1. StudyEvent: ODM
    1. Vital Signs
Administrative
Descripción

Administrative

Alias
UMLS CUI-1
C1320722
Subject Number
Descripción

Subject Number

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Vital Signs
Descripción

Vital Signs

Alias
UMLS CUI-1
C0518766
Study Time
Descripción

Study Time

Tipo de datos

integer

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

Vital Signs - Date and Time

Tipo de datos

datetime

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

Supine systolic blood pressure

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
mm[Hg]
Supine diastolic blood pressure
Descripción

Supine diastolic blood pressure

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
mm[Hg]
Supine heart rate
Descripción

Supine heart rate

Tipo de datos

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0038846
beats/min
Vital Signs Time
Descripción

Vital Signs Time

Tipo de datos

time

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

Erect systolic blood pressure

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0522014
UMLS CUI [1,2]
C0871470
mm[Hg]
Erect diastolic blood pressure
Descripción

Erect diastolic blood pressure

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0522014
UMLS CUI [1,2]
C0428883
mm[Hg]
Erect heart rate
Descripción

Erect heart rate

Tipo de datos

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1,1]
C0522014
UMLS CUI [1,2]
C0018810
beats/min
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Did the subject have a diastolic blood pressure ≥ 90 mmHg or ≤ 50 mmHg OR systolic blood pressure ≥ 140 mmHg or ≤ 90 mmHg at baseline (Day 1 pre-dose of Period 1)?
Descripción

If ’Yes’ the subject must be excluded from the study.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0428883
UMLS CUI [2]
C0871470
UMLS CUI [3]
C1442488
Vital Signs
Descripción

Vital Signs

Alias
UMLS CUI-1
C0518766
Study Time
Descripción

Study Time

Tipo de datos

integer

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

Vital Signs - Date and Time

Tipo de datos

datetime

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

Supine systolic blood pressure

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
mm[Hg]
Supine diastolic blood pressure
Descripción

Supine diastolic blood pressure

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
mm[Hg]
Supine heart rate
Descripción

Supine heart rate

Tipo de datos

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0038846
beats/min
Vital Signs Time
Descripción

Vital Signs Time

Tipo de datos

time

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

Erect systolic blood pressure

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0522014
UMLS CUI [1,2]
C0871470
mm[Hg]
Erect diastolic blood pressure
Descripción

Erect diastolic blood pressure

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0522014
UMLS CUI [1,2]
C0428883
mm[Hg]
Erect heart rate
Descripción

Erect heart rate

Tipo de datos

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1,1]
C0522014
UMLS CUI [1,2]
C0018810
beats/min
Vital Signs
Descripción

Vital Signs

Alias
UMLS CUI-1
C0518766
Study Time
Descripción

Study Time

Tipo de datos

integer

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

Vital Signs - Date and Time

Tipo de datos

datetime

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

Supine systolic blood pressure

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
mm[Hg]
Supine diastolic blood pressure
Descripción

Supine diastolic blood pressure

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
mm[Hg]
Supine heart rate
Descripción

Supine heart rate

Tipo de datos

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0038846
beats/min
Vital Signs Time
Descripción

Vital Signs Time

Tipo de datos

time

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

Erect systolic blood pressure

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0522014
UMLS CUI [1,2]
C0871470
mm[Hg]
Erect diastolic blood pressure
Descripción

Erect diastolic blood pressure

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0522014
UMLS CUI [1,2]
C0428883
mm[Hg]
Erect heart rate
Descripción

Erect heart rate

Tipo de datos

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1,1]
C0522014
UMLS CUI [1,2]
C0018810
beats/min
Vital Signs (Follow-Up)
Descripción

Vital Signs (Follow-Up)

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C1522577
Vital Signs - Date and Time
Descripción

Vital Signs - Date and Time

Tipo de datos

datetime

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

Supine systolic blood pressure

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
mm[Hg]
Supine diastolic blood pressure
Descripción

Supine diastolic blood pressure

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
mm[Hg]
Supine heart rate
Descripción

Supine heart rate

Tipo de datos

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0038846
beats/min
Vital Signs Time
Descripción

Vital Signs Time

Tipo de datos

time

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

Erect systolic blood pressure

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0522014
UMLS CUI [1,2]
C0871470
mm[Hg]
Erect diastolic blood pressure
Descripción

Erect diastolic blood pressure

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0522014
UMLS CUI [1,2]
C0428883
mm[Hg]
Erect heart rate
Descripción

Erect heart rate

Tipo de datos

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1,1]
C0522014
UMLS CUI [1,2]
C0018810
beats/min
Research Physician’s Signature:
Descripción

Research Physician’s Signature:

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

Research Physician’s Signature

Tipo de datos

text

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

Research Physician’s Signature date

Tipo de datos

date

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

Vital Signs

1 formularios
  1. StudyEvent: ODM
    1. Vital Signs
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Item
Study Time
integer
C2348563 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Study Time
Code List
Study Time
CL Item
Pre-dose (1)
CL Item
+18hrs (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
Exclusion Criteria
C0680251 (UMLS CUI-1)
Did the subject have a diastolic blood pressure ≥ 90 mmHg or ≤ 50 mmHg OR systolic blood pressure ≥ 140 mmHg or ≤ 90 mmHg at baseline (Day 1 pre-dose of Period 1)?
Item
Did the subject have a diastolic blood pressure ≥ 90 mmHg or ≤ 50 mmHg OR systolic blood pressure ≥ 140 mmHg or ≤ 90 mmHg at baseline (Day 1 pre-dose of Period 1)?
boolean
C0428883 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C1442488 (UMLS CUI [3])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Item
Study Time
integer
C2348563 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Study Time
Code List
Study Time
CL Item
Pre-dose  (1)
CL Item
+2hrs (2)
CL Item
+4hrs (3)
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
Vital Signs
C0518766 (UMLS CUI-1)
Item
Study Time
integer
C2348563 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Study Time
Code List
Study Time
CL Item
Pre-dose  (1)
CL Item
+2 hrs  (2)
CL Item
+8 hrs (3)
CL Item
+ 18 hrs (4)
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
Vital Signs (Follow-Up)
C0518766 (UMLS CUI-1)
C1522577 (UMLS CUI-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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