ID

25636

Description

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.

Keywords

Versions (2)
  1. 8/6/17 8/6/17 -
  2. 9/7/17 9/7/17 -
Uploaded on

September 7, 2017

DOI

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License

Creative Commons BY-NC 3.0
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12-lead ECG GSK study Dyskinesia in Parkinson's disease NCT00363727

English

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

1 forms  
General information
Description

General information

Protocol identifier
Description

Protocol identifier

Data type

text

Alias
UMLS CUI [1]
C2826693
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Visit description
Description

Visit description

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0678257
12-lead ECG
Description

12-lead ECG

Date of ECG
Description

Date of ECG

Data type

date

Alias
UMLS CUI [1]
C2826640
Time of ECG
Description

Time of ECG

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0013798
Ventricular Rate
Description

Ventricular Rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C2189285
beats/min
PR Interval
Description

PR Interval

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429087
msec
QRS Duration
Description

QRS Duration

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429025
msec
Uncorrected QT Interval
Description

Uncorrected QT Interval

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1287082
msec
QTc Interval
Description

QTc Interval

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1]
C0855331
msec
Method of QTc Calculation
Description

Method of QTc Calculation

Data type

integer

Result of the ECG
Description

ECG results

Data type

integer

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Similar models

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

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
General information
Protocol identifier
Item
Protocol identifier
text
C2826693 (UMLS CUI [1])
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit description
Item
Visit description
text
C0545082 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Item Group
12-lead ECG
Date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
Time of ECG
Item
Time of ECG
time
C0040223 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
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
Method of QTc Calculation
Code List
Method of QTc Calculation
CL Item
Machine (1)
CL Item
Manual (2)
Item
Result of the ECG
integer
ECG results
Code List
Result of the ECG
CL Item
Normal (1)
C0522054 (UMLS CUI-1)
(Comment:en)
CL Item
Abnormal - not clinically significant (2)
C0522055 (UMLS CUI-1)
C2826632 (UMLS CUI-2)
(Comment:en)
CL Item
Abnormal - clinically significant (3)
C0522055 (UMLS CUI-1)
C2826632 (UMLS CUI-2)
(Comment:en)
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