ID

35044

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. 2/12/19 2/12/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

February 12, 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

Baseline - Vital Signs Pre-Dose; Subject's Food Intake; 12-Lead-ECG - Pre-Dose; Randomisation Number; Investigational Product; Vital Signs - Post-Dose

1 forms  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

integer

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

Vital Signs - Pre-Dose

Alias
UMLS CUI-1
C0518766
Planned Relative Time
Description

e.g. pre-dose

Data type

text

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

Actual Time

Data type

time

Alias
UMLS CUI [1]
C0040223
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
Subject's Food Intake
Description

Subject's Food Intake

Alias
UMLS CUI-1
C0518037
Date and time of finishing last meal prior to the Baseline Visit:
Description

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

Data type

datetime

Alias
UMLS CUI [1]
C0578574
12-Lead ECG - Pre-Dose
Description

12-Lead ECG - Pre-Dose

Alias
UMLS CUI-1
C0430456
Result of the ECG
Description

Note: Perform ECGs in triplicate at least 2 hours after the subject’s last meal. Note: If abnormal, document abnormality in the Investigator Comment Log. Note: If any clinically significant abnormalities are still noted on pre-dose ECG, the subject is NOT eligible for the study. Check one:

Data type

integer

Alias
UMLS CUI [1]
C0438154
Randomisation Number
Description

Randomisation Number

Alias
UMLS CUI-1
C0034656
UMLS CUI-2
C0237753
Randomisation Number
Description

Randomisation Number

Data type

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Investigational Product
Description

Investigational Product

Alias
UMLS CUI-1
C0304229
Date of Dose
Description

Date of Dose

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
Time of Dose
Description

Time of Dose

Data type

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0040223
Vital Signs - 2 Hours Post-Dose
Description

Vital Signs - 2 Hours Post-Dose

Alias
UMLS CUI-1
C0518766
Planned Relative Time
Description

e.g., 15 min

Data type

text

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

Actual Time

Data type

time

Alias
UMLS CUI [1]
C0040223
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
Vital Signs - 4 Hours Post-Dose
Description

Vital Signs - 4 Hours Post-Dose

Alias
UMLS CUI-1
C0518766
Planned Relative Time
Description

e.g., 15 min

Data type

time

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

Actual Time

Data type

time

Alias
UMLS CUI [1]
C0040223
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

Baseline - Vital Signs Pre-Dose; Subject's Food Intake; 12-Lead-ECG - Pre-Dose; Randomisation Number; Investigational Product; Vital Signs - Post-Dose

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
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 Baseline Visit:
Item
Date and time of finishing last meal prior to the Baseline Visit:
datetime
C0578574 (UMLS CUI [1])
Item Group
12-Lead ECG - Pre-Dose
C0430456 (UMLS CUI-1)
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
Result of the ECG
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
Item Group
Randomisation Number
C0034656 (UMLS CUI-1)
C0237753 (UMLS CUI-2)
Randomisation Number
Item
Randomisation Number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
Date of Dose
Item
Date of Dose
date
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Time of Dose
Item
Time of Dose
time
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
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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