ID

35121

Description

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

Keywords

Versions (1)
  1. 2/18/19 2/18/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

February 18, 2019

DOI

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License

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

English

Week 1 - Vital Signs; Onset of Improvement; Week 2,3,4,5,6,8 - Vital Signs

1 forms  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Week 1 - Vital Signs
Description

Week 1 - Vital Signs

Alias
UMLS CUI-1
C0518766
Systolic Blood Pressure
Description

Systolic Blood Pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Description

Diastolic Blood Pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Subject position
Description

Subject position

Data type

integer

Alias
UMLS CUI [1]
C1262869
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Onset of Improvement
Description

Onset of Improvement

Alias
UMLS CUI-1
C2986411
UMLS CUI-2
C0332162
Date of first improvement in RLS Symptoms
Description

What is the date that the subject first recalled improvement in RLS symptoms (if present) during the past week of treatment, whether or not they believe it is entirely due to drug treatment?

Data type

date

Alias
UMLS CUI [1,1]
C2986411
UMLS CUI [1,2]
C0574845
UMLS CUI [1,3]
C0035258
UMLS CUI [1,4]
C1457887
Check, if subject did NOT experience any improvement during the past week
Description

Check, if subject did NOT experience any improvement during the past week

Data type

integer

Alias
UMLS CUI [1,1]
C3844714
UMLS CUI [1,2]
C0035258
UMLS CUI [1,3]
C1457887
Week 2 - Vital Signs
Description

Week 2 - Vital Signs

Alias
UMLS CUI-1
C0518766
Systolic Blood Pressure
Description

Systolic Blood Pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Description

Diastolic Blood Pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Subject position
Description

Subject position

Data type

integer

Alias
UMLS CUI [1]
C1262869
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Week 3 - Vital Signs
Description

Week 3 - Vital Signs

Alias
UMLS CUI-1
C0518766
Systolic Blood Pressure
Description

Systolic Blood Pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Description

Diastolic Blood Pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Subject position
Description

Subject position

Data type

integer

Alias
UMLS CUI [1]
C1262869
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Week 4 - Vital Signs
Description

Week 4 - Vital Signs

Alias
UMLS CUI-1
C0518766
Systolic Blood Pressure
Description

Systolic Blood Pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Description

Diastolic Blood Pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Subject position
Description

Subject position

Data type

integer

Alias
UMLS CUI [1]
C1262869
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Week 5 - Vital Signs
Description

Week 5 - Vital Signs

Alias
UMLS CUI-1
C0518766
Systolic Blood Pressure
Description

Systolic Blood Pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Description

Diastolic Blood Pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Subject position
Description

Subject position

Data type

integer

Alias
UMLS CUI [1]
C1262869
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Week 6 - Vital Signs
Description

Week 6 - Vital Signs

Alias
UMLS CUI-1
C0518766
Systolic Blood Pressure
Description

Systolic Blood Pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Description

Diastolic Blood Pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Subject position
Description

Subject position

Data type

integer

Alias
UMLS CUI [1]
C1262869
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Week 8 - Vital Signs
Description

Week 8 - Vital Signs

Alias
UMLS CUI-1
C0518766
Systolic Blood Pressure
Description

Systolic Blood Pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Description

Diastolic Blood Pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Subject position
Description

Subject position

Data type

integer

Alias
UMLS CUI [1]
C1262869
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
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Similar models

Week 1 - Vital Signs; Onset of Improvement; Week 2,3,4,5,6,8 - Vital Signs

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item Group
Week 1 - Vital Signs
C0518766 (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
Onset of Improvement
C2986411 (UMLS CUI-1)
C0332162 (UMLS CUI-2)
Date of first improvement in RLS Symptoms
Item
Date of first improvement in RLS Symptoms
date
C2986411 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
Item
Check, if subject did NOT experience any improvement during the past week
integer
C3844714 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
Check, if subject did NOT experience any improvement during the past week
Code List
Check, if subject did NOT experience any improvement during the past week
CL Item
Subject did NOT experience any improvement during the past week (1)
Item Group
Week 2 - Vital Signs
C0518766 (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
Week 3 - Vital Signs
C0518766 (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
Week 4 - Vital Signs
C0518766 (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
Week 5 - Vital Signs
C0518766 (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
Week 6 - Vital Signs
C0518766 (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
Week 8 - Vital Signs
C0518766 (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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