ID

35122

Descripción

Study ID: 101468/205 Clinical Study ID: 101468/205 Study Title:A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole XR (Extended Release) in Patients with Restless Legs Syndrome Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00197080 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 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 (1)
  1. 18/2/19 18/2/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

18 de febrero de 2019

DOI

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Licencia

Creative Commons BY-NC 3.0
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Efficacy and Safety of Ropinirole XR (Extended Release) in Patients with Restless Legs Syndrome NCT00197080

Inglés

Week 10 - Vital Signs Pre-Dose; Subject's Food Intake; Investigational Product; Vital Signs - Post-Dose

1 formularios  
Administrative
Descripción

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Descripción

Subject Identifier

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Vital Signs - Pre-Dose
Descripción

Vital Signs - Pre-Dose

Alias
UMLS CUI-1
C0518766
Planned Relative Time
Descripción

e.g. pre-dose

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0439564
Actual Time
Descripción

Actual Time

Tipo de datos

time

Alias
UMLS CUI [1]
C0040223
Systolic Blood Pressure
Descripción

Systolic Blood Pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Descripción

Diastolic Blood Pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Subject position
Descripción

Subject position

Tipo de datos

integer

Alias
UMLS CUI [1]
C1262869
Heart Rate
Descripción

Heart Rate

Tipo de datos

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Subject's Food Intake
Descripción

Subject's Food Intake

Alias
UMLS CUI-1
C0518037
Date and time of finishing last meal prior to the Week 10 Visit:
Descripción

Note: ECG measures should be taken two or more hours after a meal.

Tipo de datos

datetime

Alias
UMLS CUI [1]
C0578574
Investigational Product
Descripción

Investigational Product

Alias
UMLS CUI-1
C0304229
Dose Start Date
Descripción

Dose Start Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0808070
Dose Start Time
Descripción

Dose Start Time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1301880
Dose
Descripción

e.g., Last dose prior to Week 10

Tipo de datos

text

Alias
UMLS CUI [1]
C3174092
Vital Signs - 2 Hours Post-Dose
Descripción

Vital Signs - 2 Hours Post-Dose

Alias
UMLS CUI-1
C0518766
Planned Relative Time
Descripción

e.g., 15 min

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0439564
Actual Time
Descripción

Actual Time

Tipo de datos

time

Alias
UMLS CUI [1]
C0040223
Systolic Blood Pressure
Descripción

Systolic Blood Pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Descripción

Diastolic Blood Pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Subject position
Descripción

Subject position

Tipo de datos

integer

Alias
UMLS CUI [1]
C1262869
Heart Rate
Descripción

Heart Rate

Tipo de datos

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Vital Signs - 4 Hours Post-Dose
Descripción

Vital Signs - 4 Hours Post-Dose

Alias
UMLS CUI-1
C0518766
Planned Relative Time
Descripción

e.g., 15 min

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0439564
Actual Time
Descripción

Actual Time

Tipo de datos

time

Alias
UMLS CUI [1]
C0040223
Systolic Blood Pressure
Descripción

Systolic Blood Pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Descripción

Diastolic Blood Pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Subject position
Descripción

Subject position

Tipo de datos

integer

Alias
UMLS CUI [1]
C1262869
Heart Rate
Descripción

Heart Rate

Tipo de datos

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
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Similar models

Week 10 - Vital Signs Pre-Dose; Subject's Food Intake; Investigational Product; Vital Signs - Post-Dose

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item Group
Vital Signs - Pre-Dose
C0518766 (UMLS CUI-1)
Planned Relative Time
Item
Planned Relative Time
text
C0518766 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1])
Item
Subject position
integer
C1262869 (UMLS CUI [1])
Subject position
Code List
Subject position
CL Item
Supine (1)
CL Item
Sitting (2)
CL Item
Standing (3)
CL Item
Semi-supine (4)
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Item Group
Subject's Food Intake
C0518037 (UMLS CUI-1)
Date and time of finishing last meal prior to the Week 10 Visit:
Item
Date and time of finishing last meal prior to the Week 10 Visit:
datetime
C0578574 (UMLS CUI [1])
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
Dose Start Date
Item
Dose Start Date
date
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Dose Start Time
Item
Dose Start Time
time
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Dose
Item
Dose
text
C3174092 (UMLS CUI [1])
Item Group
Vital Signs - 2 Hours Post-Dose
C0518766 (UMLS CUI-1)
Planned Relative Time
Item
Planned Relative Time
text
C0518766 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1])
Item
Subject position
integer
C1262869 (UMLS CUI [1])
Subject position
Code List
Subject position
CL Item
Supine  (1)
CL Item
Sitting  (2)
CL Item
Standing  (3)
CL Item
Semi-supine (4)
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Item Group
Vital Signs - 4 Hours Post-Dose
C0518766 (UMLS CUI-1)
Planned Relative Time
Item
Planned Relative Time
time
C0518766 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1])
Item
Subject position
integer
C1262869 (UMLS CUI [1])
Subject position
Code List
Subject position
CL Item
Supine  (1)
CL Item
Sitting  (2)
CL Item
Standing  (3)
CL Item
Semi-supine (4)
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Volver a la parte superior de la página 

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