ID

27197

Beskrivning

Study ID: 101468/168 Clinical Study ID: 101468/168 Study Title: A Randomised, Double Blind, Three Period, Cross-Over Study of Ropinirole CR and Ropinirole IR Monotherapy Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara Study Indication: Parkinson Disease

Nyckelord

Versioner (3)
  1. 2017-09-20 2017-09-20 -
  2. 2017-09-20 2017-09-20 -
  3. 2017-11-03 2017-11-03 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

3 november 2017

DOI

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Licens

Creative Commons BY-NC 3.0
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visit week 12 physical examination Ropinirole CR Ropinirole IR Monotherapy 101468/168

Engelsk

visit week 12 physical examination Ropinirole CR Ropinirole IR Monotherapy 101468/168

1 Formulär  
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Beskrivning

subject number

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
VITAL SIGNS
Beskrivning

VITAL SIGNS

Alias
UMLS CUI-1
C0518766
Semi-Supine Blood Pressure Systolic
Beskrivning

semi-supine blood pressure systolic

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
mmHg
Semi-Supine Blood Pressure Diastolic
Beskrivning

semi-supine blood pressure diastolic

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
beats/min
Semi-Supine Heart Rate
Beskrivning

semi-supine heart rate

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1,1]
C0522019
UMLS CUI [1,2]
C0018810
beats/min
Standing Blood Pressure Systolic
Beskrivning

standing blood pressure systolic

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0231472
mmHg
Standing Blood Pressure Diastolic
Beskrivning

standing blood pressure diastolic

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0231472
beats/min
Standing Heart Rate
Beskrivning

standing heart rate

Datatyp

integer

Alias
UMLS CUI [1]
C2029905
12-LEAD ECG
Beskrivning

12-LEAD ECG

Alias
UMLS CUI-1
C0430456
Date of ECG
Beskrivning

date of ECG

Datatyp

date

Alias
UMLS CUI [1]
C2826640
Result of ECG
Beskrivning

ECG Finding

Datatyp

integer

Alias
UMLS CUI [1]
C0438154
CENTRAL LABORATORY
Beskrivning

CENTRAL LABORATORY

Alias
UMLS CUI-1
C1880016
Date sample taken
Beskrivning

date sample taken

Datatyp

date

Alias
UMLS CUI [1]
C1302413
CLINICAL GLOBAL IMPRESSION (CGI-S)
Beskrivning

CLINICAL GLOBAL IMPRESSION (CGI-S)

Alias
UMLS CUI-1
C3639708
CLINICAL GLOBAL IMPRESSION (CGI-S)
Beskrivning

clinical global impression questionnaire

Datatyp

text

Alias
UMLS CUI [1]
C3639708
UNIFIED PARKINSONS DISEASE RATING SCALE
Beskrivning

UNIFIED PARKINSONS DISEASE RATING SCALE

Alias
UMLS CUI-1
C3639721
UNIFIED PARKINSONS DISEASE RATING SCALE
Beskrivning

unified parkinson's disease rating scale questionnaire

Datatyp

text

Alias
UMLS CUI [1]
C3639721
PARKINSON’S DISEASE SLEEP SCALE (PDSS)
Beskrivning

PARKINSON’S DISEASE SLEEP SCALE (PDSS)

Alias
UMLS CUI-1
C0030567
UMLS CUI-2
C0037313
PARKINSON’S DISEASE SLEEP SCALE (PDSS)
Beskrivning

parkinson's disease sleep scale

Datatyp

text

Alias
UMLS CUI [1,1]
C0851578
UMLS CUI [1,2]
C0681889
BECK DEPRESSION INVENTORY
Beskrivning

BECK DEPRESSION INVENTORY

Ensure the subject has completed the week 12 Beck Depression Inventory
Beskrivning

Beck Depression Inventory completion

Datatyp

boolean

Epworth Sleepiness Scale
Beskrivning

Epworth Sleepiness Scale

Ensure the subject has completed the week 12 Epworth Sleepiness Scale
Beskrivning

Epworth Sleepiness Scale completion

Datatyp

boolean

Stable UPDRS motor score
Beskrivning

Stable UPDRS motor score

Stable UPDRS motor score
Beskrivning

A subject must have a stable UPDRS motor score in order to proceed into the next phase of the study. A stable UPDRS motor score is defined as a score which does not change by more than +/- 2 points during at least the final two visits of the titration phase (Weeks 10 and 12).

Datatyp

boolean

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Similar models

visit week 12 physical examination Ropinirole CR Ropinirole IR Monotherapy 101468/168

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
subject number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
VITAL SIGNS
C0518766 (UMLS CUI-1)
semi-supine blood pressure systolic
Item
Semi-Supine Blood Pressure Systolic
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
semi-supine blood pressure diastolic
Item
Semi-Supine Blood Pressure Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
semi-supine heart rate
Item
Semi-Supine Heart Rate
integer
C0522019 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
standing blood pressure systolic
Item
Standing Blood Pressure Systolic
integer
C0871470 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
standing blood pressure diastolic
Item
Standing Blood Pressure Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
standing heart rate
Item
Standing Heart Rate
integer
C2029905 (UMLS CUI [1])
Item Group
12-LEAD ECG
C0430456 (UMLS CUI-1)
date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
Item
Result of ECG
integer
C0438154 (UMLS CUI [1])
ECG Finding
Code List
Result of ECG
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant (2)
CL Item
Abnormal - clinically significant -> Complete an Adverse Event (AE) or Serious Adverse Event  (3)
CL Item
(SAE) page(s) if clinically significant abnormalities meet the (4)
CL Item
protocol definition for an AE or SAE. (5)
Item Group
CENTRAL LABORATORY
C1880016 (UMLS CUI-1)
date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
Item Group
CLINICAL GLOBAL IMPRESSION (CGI-S)
C3639708 (UMLS CUI-1)
clinical global impression questionnaire
Item
CLINICAL GLOBAL IMPRESSION (CGI-S)
text
C3639708 (UMLS CUI [1])
Item Group
UNIFIED PARKINSONS DISEASE RATING SCALE
C3639721 (UMLS CUI-1)
unified parkinson's disease rating scale questionnaire
Item
UNIFIED PARKINSONS DISEASE RATING SCALE
text
C3639721 (UMLS CUI [1])
Item Group
PARKINSON’S DISEASE SLEEP SCALE (PDSS)
C0030567 (UMLS CUI-1)
C0037313 (UMLS CUI-2)
parkinson's disease sleep scale
Item
PARKINSON’S DISEASE SLEEP SCALE (PDSS)
text
C0851578 (UMLS CUI [1,1])
C0681889 (UMLS CUI [1,2])
Item Group
BECK DEPRESSION INVENTORY
Beck Depression Inventory completion
Item
Ensure the subject has completed the week 12 Beck Depression Inventory
boolean
Item Group
Epworth Sleepiness Scale
Epworth Sleepiness Scale completion
Item
Ensure the subject has completed the week 12 Epworth Sleepiness Scale
boolean
Item Group
Stable UPDRS motor score
Stable UPDRS motor score
Item
Stable UPDRS motor score
boolean
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