ID

35122

Beschrijving

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

Trefwoorden

Versies (1)
  1. 18-02-19 18-02-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

18 februari 2019

DOI

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Licentie

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

Engels

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

1 Formulieren  
Administrative
Beschrijving

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschrijving

Subject Identifier

Datatype

integer

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

Vital Signs - Pre-Dose

Alias
UMLS CUI-1
C0518766
Planned Relative Time
Beschrijving

e.g. pre-dose

Datatype

text

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

Actual Time

Datatype

time

Alias
UMLS CUI [1]
C0040223
Systolic Blood Pressure
Beschrijving

Systolic Blood Pressure

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Beschrijving

Diastolic Blood Pressure

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Subject position
Beschrijving

Subject position

Datatype

integer

Alias
UMLS CUI [1]
C1262869
Heart Rate
Beschrijving

Heart Rate

Datatype

integer

Maateenheden
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Subject's Food Intake
Beschrijving

Subject's Food Intake

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

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

Datatype

datetime

Alias
UMLS CUI [1]
C0578574
Investigational Product
Beschrijving

Investigational Product

Alias
UMLS CUI-1
C0304229
Dose Start Date
Beschrijving

Dose Start Date

Datatype

date

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

Dose Start Time

Datatype

time

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

e.g., Last dose prior to Week 10

Datatype

text

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

Vital Signs - 2 Hours Post-Dose

Alias
UMLS CUI-1
C0518766
Planned Relative Time
Beschrijving

e.g., 15 min

Datatype

text

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

Actual Time

Datatype

time

Alias
UMLS CUI [1]
C0040223
Systolic Blood Pressure
Beschrijving

Systolic Blood Pressure

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Beschrijving

Diastolic Blood Pressure

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Subject position
Beschrijving

Subject position

Datatype

integer

Alias
UMLS CUI [1]
C1262869
Heart Rate
Beschrijving

Heart Rate

Datatype

integer

Maateenheden
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Vital Signs - 4 Hours Post-Dose
Beschrijving

Vital Signs - 4 Hours Post-Dose

Alias
UMLS CUI-1
C0518766
Planned Relative Time
Beschrijving

e.g., 15 min

Datatype

time

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

Actual Time

Datatype

time

Alias
UMLS CUI [1]
C0040223
Systolic Blood Pressure
Beschrijving

Systolic Blood Pressure

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Beschrijving

Diastolic Blood Pressure

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Subject position
Beschrijving

Subject position

Datatype

integer

Alias
UMLS CUI [1]
C1262869
Heart Rate
Beschrijving

Heart Rate

Datatype

integer

Maateenheden
  • 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 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
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