ID

24568

Beskrivning

Study ID: 101468/228 Clinical Study ID: 101468/228 Study Title:A two year Phase IIIb randomised, multicenter, double-blind, SINEMET controlled, parallel group, flexible dose study, to assess the effectiveness of controlled release ropinirole add-on therapy to L-dopa at increasing the time to onset of dyskinesia in Parkinson's disease subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00363727 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Dyskinesias; Parkinson Disease; Parkinson's Disease Study part: 12-lead ECG.

Nyckelord

  1. 2017-08-06 2017-08-06 -
  2. 2017-09-07 2017-09-07 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

6 augusti 2017

DOI

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Licens

Creative Commons BY-NC 3.0

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12-lead ECG GSK study Dyskinesia in Parkinson's disease NCT00363727

12-lead ECG GSK study Dyskinesia in Parkinson's disease NCT00363727

General information
Beskrivning

General information

Protocol identifier
Beskrivning

Protocol identifier

Datatyp

text

Subject Identifier
Beskrivning

Subject Identifier

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Visit description
Beskrivning

Visit description

Datatyp

text

12-lead ECG
Beskrivning

12-lead ECG

Date of ECG
Beskrivning

Date of ECG

Datatyp

date

Time of ECG
Beskrivning

Time of ECG

Datatyp

time

Ventricular Rate
Beskrivning

Ventricular Rate

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C2189285
beats/min
PR Interval
Beskrivning

PR Interval

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429087
msec
QRS Duration
Beskrivning

QRS Duration

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429025
msec
Uncorrected QT Interval
Beskrivning

Uncorrected QT Interval

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1287082
msec
QTc Interval
Beskrivning

QTc Interval

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0855331
msec
Method of QTc Calculation
Beskrivning

Method of QTc Calculation

Datatyp

integer

Result of the ECG
Beskrivning

ECG results

Datatyp

integer

Similar models

12-lead ECG GSK study Dyskinesia in Parkinson's disease NCT00363727

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
General information
Protocol identifier
Item
Protocol identifier
text
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit description
Item
Visit description
text
Item Group
12-lead ECG
Date of ECG
Item
Date of ECG
date
Time of ECG
Item
Time of ECG
time
Ventricular Rate
Item
Ventricular Rate
integer
C0430456 (UMLS CUI [1,1])
C2189285 (UMLS CUI [1,2])
PR Interval
Item
PR Interval
integer
C0430456 (UMLS CUI [1,1])
C0429087 (UMLS CUI [1,2])
QRS Duration
Item
QRS Duration
integer
C0430456 (UMLS CUI [1,1])
C0429025 (UMLS CUI [1,2])
Uncorrected QT Interval
Item
Uncorrected QT Interval
integer
C0430456 (UMLS CUI [1,1])
C1287082 (UMLS CUI [1,2])
QTc Interval
Item
QTc Interval
integer
C0855331 (UMLS CUI [1])
Item
Method of QTc Calculation
integer
Code List
Method of QTc Calculation
CL Item
Machine (1)
CL Item
Manual (2)
Item
Result of the ECG
integer
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant (2)
CL Item
Abnormal - clinically significant (3)

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