ID

24568

Beschrijving

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.

Trefwoorden

  1. 06-08-17 06-08-17 -
  2. 07-09-17 07-09-17 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

6 augustus 2017

DOI

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Licentie

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
Beschrijving

General information

Protocol identifier
Beschrijving

Protocol identifier

Datatype

text

Subject Identifier
Beschrijving

Subject Identifier

Datatype

text

Alias
UMLS CUI [1]
C2348585
Visit description
Beschrijving

Visit description

Datatype

text

12-lead ECG
Beschrijving

12-lead ECG

Date of ECG
Beschrijving

Date of ECG

Datatype

date

Time of ECG
Beschrijving

Time of ECG

Datatype

time

Ventricular Rate
Beschrijving

Ventricular Rate

Datatype

integer

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

PR Interval

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429087
msec
QRS Duration
Beschrijving

QRS Duration

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429025
msec
Uncorrected QT Interval
Beschrijving

Uncorrected QT Interval

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1287082
msec
QTc Interval
Beschrijving

QTc Interval

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1]
C0855331
msec
Method of QTc Calculation
Beschrijving

Method of QTc Calculation

Datatype

integer

Result of the ECG
Beschrijving

ECG results

Datatype

integer

Similar models

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

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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