ID
39420
Beskrivning
Study ID: 111569 Clinical Study ID: 111569 Study Title: A fixed dose, dose-response study for ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01494532 Sponsor: GlaxoSmithKline Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Ropinirole, placebo Study Indication: Parkinson's Disease
Nyckelord
Versioner (3)
- 2019-12-03 2019-12-03 -
- 2019-12-06 2019-12-06 -
- 2020-01-09 2020-01-09 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
9 januari 2020
DOI
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Licens
Creative Commons BY-NC 3.0
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Ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease (NCT01494532)
Baseline - Consent; Central Laboratory; Diary; ECG
- StudyEvent: ODM
Beskrivning
Randomisation
Alias
- UMLS CUI-1
- C0034656
Beskrivning
Was the subject able to be randomised?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0034656
Beskrivning
Randomisation Number
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
Beskrivning
Date of Randomisation
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0011008
Beskrivning
Electronically Transferred Lab Data
Alias
- UMLS CUI-1
- C0745590
- UMLS CUI-2
- C1705822
Beskrivning
Laboratory Test
Datatyp
integer
Alias
- UMLS CUI [1]
- C0022885
Beskrivning
Sample collection date
Datatyp
date
Alias
- UMLS CUI [1]
- C1302413
Beskrivning
Sample collection time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0005834
Beskrivning
Laboratory Test not done
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C1272696
Beskrivning
Possible Liver Events
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
- UMLS CUI-3
- C0332149
Beskrivning
Diary - Target Day 1
Alias
- UMLS CUI-1
- C3890583
- UMLS CUI-2
- C1521840
- UMLS CUI-3
- C0439228
Beskrivning
Diary - Target Day 2
Alias
- UMLS CUI-1
- C3890583
- UMLS CUI-2
- C1521840
- UMLS CUI-3
- C0439228
Beskrivning
Target Day 2 - Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1521840
- UMLS CUI [1,2]
- C0439228
- UMLS CUI [1,3]
- C0011008
Beskrivning
Target Day 2 - Time of awakening
Datatyp
time
Alias
- UMLS CUI [1,1]
- C1521840
- UMLS CUI [1,2]
- C0439228
- UMLS CUI [1,3]
- C1720052
- UMLS CUI [1,4]
- C0040223
Beskrivning
State you woke up in, following your overnight sleep
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1521840
- UMLS CUI [1,2]
- C0439228
- UMLS CUI [1,3]
- C1720052
- UMLS CUI [1,4]
- C1442792
Beskrivning
Time you took your study medication
Datatyp
time
Alias
- UMLS CUI [1,1]
- C1521840
- UMLS CUI [1,2]
- C0439228
- UMLS CUI [1,3]
- C0013227
- UMLS CUI [1,4]
- C0040223
Beskrivning
Diary Day 2
Alias
- UMLS CUI-1
- C3890583
- UMLS CUI-2
- C0439228
Beskrivning
Timepoint
Datatyp
integer
Alias
- UMLS CUI [1]
- C2348792
Beskrivning
State
Datatyp
integer
Alias
- UMLS CUI [1]
- C1442792
Beskrivning
Troublesome dyskinesia
Datatyp
integer
Alias
- UMLS CUI [1]
- C0013384
Beskrivning
Target Day 3
Alias
- UMLS CUI-1
- C1521840
- UMLS CUI-2
- C0439228
Beskrivning
Target Day 3 - Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1521840
- UMLS CUI [1,2]
- C0439228
- UMLS CUI [1,3]
- C0011008
Beskrivning
Target Day 3 - Time of awakening
Datatyp
time
Alias
- UMLS CUI [1,1]
- C1521840
- UMLS CUI [1,2]
- C0439228
- UMLS CUI [1,3]
- C1720052
- UMLS CUI [1,4]
- C0040223
Beskrivning
State you woke up in, following your overnight sleep
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1521840
- UMLS CUI [1,2]
- C0439228
- UMLS CUI [1,3]
- C1720052
- UMLS CUI [1,4]
- C1442792
Beskrivning
Time you took your study medication
Datatyp
time
Alias
- UMLS CUI [1,1]
- C1521840
- UMLS CUI [1,2]
- C0439228
- UMLS CUI [1,3]
- C0013227
- UMLS CUI [1,4]
- C0040223
Beskrivning
Diary Day 3
Alias
- UMLS CUI-1
- C3890583
- UMLS CUI-2
- C0439228
Beskrivning
Timepoint
Datatyp
integer
Alias
- UMLS CUI [1]
- C2348792
Beskrivning
Troublesome dyskinesia
Datatyp
integer
Alias
- UMLS CUI [1]
- C0013384
Beskrivning
12 Lead Electrocardiogram
Alias
- UMLS CUI-1
- C0430456
Beskrivning
ECG Information
Alias
- UMLS CUI-1
- C1623258
- UMLS CUI-2
- C1533716
Beskrivning
ECG Sequence Number
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C2348184
Beskrivning
Date and time of ECG
Datatyp
datetime
Alias
- UMLS CUI [1]
- C2826846
Beskrivning
Heart rate
Datatyp
integer
Måttenheter
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beskrivning
PR Interval
Datatyp
integer
Måttenheter
- ms
Alias
- UMLS CUI [1]
- C0429087
Beskrivning
QRS Duration
Datatyp
integer
Måttenheter
- ms
Alias
- UMLS CUI [1]
- C0429025
Beskrivning
Uncorrected QT Interval
Datatyp
integer
Måttenheter
- ms
Alias
- UMLS CUI [1]
- C1287082
Beskrivning
Method of QTc Calculation
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
Beskrivning
Record the RR interval that precedes the measured QT interval
Datatyp
integer
Måttenheter
- ms
Alias
- UMLS CUI [1,1]
- C0489636
- UMLS CUI [1,2]
- C0332152
- UMLS CUI [1,3]
- C0855331
Beskrivning
RR interval not available
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0489636
- UMLS CUI [1,2]
- C0470187
Beskrivning
QTcB (Bazett)
Datatyp
integer
Alias
- UMLS CUI [1]
- C1882512
Beskrivning
QTcB (Bazett) finding
Datatyp
integer
Måttenheter
- ms
Alias
- UMLS CUI [1,1]
- C1882512
- UMLS CUI [1,2]
- C0243095
Beskrivning
QTcF (Fridericia)
Datatyp
integer
Alias
- UMLS CUI [1]
- C1882513
Beskrivning
QTcF (Fridericia) finding
Datatyp
integer
Måttenheter
- ms
Alias
- UMLS CUI [1,1]
- C1882513
- UMLS CUI [1,2]
- C0243095
Beskrivning
QTc Interval, other method of correction
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
- UMLS CUI [1,3]
- C0205394
Beskrivning
Is this a repeat ECG?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0205341
Beskrivning
Specify reason ECG repeated
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0205341
- UMLS CUI [1,3]
- C0392360
Beskrivning
Specify other reason ECG repeated
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0205341
- UMLS CUI [1,3]
- C0392360
- UMLS CUI [1,4]
- C0205394
Beskrivning
Result of the ECG
Datatyp
integer
Alias
- UMLS CUI [1]
- C0438154
Beskrivning
Rhythm
Datatyp
integer
Alias
- UMLS CUI [1]
- C0232187
Beskrivning
Specify other rhythm
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0232187
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beskrivning
P-Wave Morphology
Datatyp
integer
Alias
- UMLS CUI [1]
- C2216025
Beskrivning
Specify other ther P-Wave Morphology
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2216025
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beskrivning
Conduction
Datatyp
integer
Alias
- UMLS CUI [1]
- C0232217
Beskrivning
Specify other conduction
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0232217
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beskrivning
Myocardial Infarction
Datatyp
integer
Alias
- UMLS CUI [1]
- C0027051
Beskrivning
Specify other myocardial infarction
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0027051
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beskrivning
Depolarisation/Repolarisation (QRS-T)
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1331539
- UMLS CUI [1,2]
- C0948857
Beskrivning
Enter Comment
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
Beskrivning
Other ECG abnormalities
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C0205394
Beskrivning
Specify other ECG abnormalities
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Similar models
Baseline - Consent; Central Laboratory; Diary; ECG
- StudyEvent: ODM
C0237753 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1705822 (UMLS CUI-2)
C0005834 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,2])
C0877248 (UMLS CUI-2)
C0332149 (UMLS CUI-3)
C0877248 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,3])
C0005834 (UMLS CUI [2])
C1521840 (UMLS CUI-2)
C0439228 (UMLS CUI-3)
C0439228 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1521840 (UMLS CUI-2)
C0439228 (UMLS CUI-3)
C0439228 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0439228 (UMLS CUI [1,2])
C1720052 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0439228 (UMLS CUI [1,2])
C1720052 (UMLS CUI [1,3])
C1442792 (UMLS CUI [1,4])
C0439228 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0439228 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0439228 (UMLS CUI [1,2])
C1720052 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0439228 (UMLS CUI [1,2])
C1720052 (UMLS CUI [1,3])
C1442792 (UMLS CUI [1,4])
C0439228 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C2348184 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,2])
C0855331 (UMLS CUI [1,3])
C0470187 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0205341 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C0205341 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0948857 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])