ID
39420
Beschrijving
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
Trefwoorden
Versies (3)
- 03-12-19 03-12-19 -
- 06-12-19 06-12-19 -
- 09-01-20 09-01-20 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
9 januari 2020
DOI
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Licentie
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
Beschrijving
Randomisation
Alias
- UMLS CUI-1
- C0034656
Beschrijving
Was the subject able to be randomised?
Datatype
boolean
Alias
- UMLS CUI [1]
- C0034656
Beschrijving
Randomisation Number
Datatype
text
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
Beschrijving
Date of Randomisation
Datatype
date
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0011008
Beschrijving
Electronically Transferred Lab Data
Alias
- UMLS CUI-1
- C0745590
- UMLS CUI-2
- C1705822
Beschrijving
Laboratory Test
Datatype
integer
Alias
- UMLS CUI [1]
- C0022885
Beschrijving
Sample collection date
Datatype
date
Alias
- UMLS CUI [1]
- C1302413
Beschrijving
Sample collection time
Datatype
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0005834
Beschrijving
Laboratory Test not done
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C1272696
Beschrijving
Possible Liver Events
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
- UMLS CUI-3
- C0332149
Beschrijving
Diary - Target Day 1
Alias
- UMLS CUI-1
- C3890583
- UMLS CUI-2
- C1521840
- UMLS CUI-3
- C0439228
Beschrijving
Diary - Target Day 2
Alias
- UMLS CUI-1
- C3890583
- UMLS CUI-2
- C1521840
- UMLS CUI-3
- C0439228
Beschrijving
Target Day 2 - Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1521840
- UMLS CUI [1,2]
- C0439228
- UMLS CUI [1,3]
- C0011008
Beschrijving
Target Day 2 - Time of awakening
Datatype
time
Alias
- UMLS CUI [1,1]
- C1521840
- UMLS CUI [1,2]
- C0439228
- UMLS CUI [1,3]
- C1720052
- UMLS CUI [1,4]
- C0040223
Beschrijving
State you woke up in, following your overnight sleep
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1521840
- UMLS CUI [1,2]
- C0439228
- UMLS CUI [1,3]
- C1720052
- UMLS CUI [1,4]
- C1442792
Beschrijving
Time you took your study medication
Datatype
time
Alias
- UMLS CUI [1,1]
- C1521840
- UMLS CUI [1,2]
- C0439228
- UMLS CUI [1,3]
- C0013227
- UMLS CUI [1,4]
- C0040223
Beschrijving
Diary Day 2
Alias
- UMLS CUI-1
- C3890583
- UMLS CUI-2
- C0439228
Beschrijving
Timepoint
Datatype
integer
Alias
- UMLS CUI [1]
- C2348792
Beschrijving
State
Datatype
integer
Alias
- UMLS CUI [1]
- C1442792
Beschrijving
Troublesome dyskinesia
Datatype
integer
Alias
- UMLS CUI [1]
- C0013384
Beschrijving
Target Day 3
Alias
- UMLS CUI-1
- C1521840
- UMLS CUI-2
- C0439228
Beschrijving
Target Day 3 - Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1521840
- UMLS CUI [1,2]
- C0439228
- UMLS CUI [1,3]
- C0011008
Beschrijving
Target Day 3 - Time of awakening
Datatype
time
Alias
- UMLS CUI [1,1]
- C1521840
- UMLS CUI [1,2]
- C0439228
- UMLS CUI [1,3]
- C1720052
- UMLS CUI [1,4]
- C0040223
Beschrijving
State you woke up in, following your overnight sleep
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1521840
- UMLS CUI [1,2]
- C0439228
- UMLS CUI [1,3]
- C1720052
- UMLS CUI [1,4]
- C1442792
Beschrijving
Time you took your study medication
Datatype
time
Alias
- UMLS CUI [1,1]
- C1521840
- UMLS CUI [1,2]
- C0439228
- UMLS CUI [1,3]
- C0013227
- UMLS CUI [1,4]
- C0040223
Beschrijving
Diary Day 3
Alias
- UMLS CUI-1
- C3890583
- UMLS CUI-2
- C0439228
Beschrijving
Timepoint
Datatype
integer
Alias
- UMLS CUI [1]
- C2348792
Beschrijving
Troublesome dyskinesia
Datatype
integer
Alias
- UMLS CUI [1]
- C0013384
Beschrijving
12 Lead Electrocardiogram
Alias
- UMLS CUI-1
- C0430456
Beschrijving
ECG Information
Alias
- UMLS CUI-1
- C1623258
- UMLS CUI-2
- C1533716
Beschrijving
ECG Sequence Number
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C2348184
Beschrijving
Date and time of ECG
Datatype
datetime
Alias
- UMLS CUI [1]
- C2826846
Beschrijving
Heart rate
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
PR Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C0429087
Beschrijving
QRS Duration
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C0429025
Beschrijving
Uncorrected QT Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C1287082
Beschrijving
Method of QTc Calculation
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
Beschrijving
Record the RR interval that precedes the measured QT interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1,1]
- C0489636
- UMLS CUI [1,2]
- C0332152
- UMLS CUI [1,3]
- C0855331
Beschrijving
RR interval not available
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0489636
- UMLS CUI [1,2]
- C0470187
Beschrijving
QTcB (Bazett)
Datatype
integer
Alias
- UMLS CUI [1]
- C1882512
Beschrijving
QTcB (Bazett) finding
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1,1]
- C1882512
- UMLS CUI [1,2]
- C0243095
Beschrijving
QTcF (Fridericia)
Datatype
integer
Alias
- UMLS CUI [1]
- C1882513
Beschrijving
QTcF (Fridericia) finding
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1,1]
- C1882513
- UMLS CUI [1,2]
- C0243095
Beschrijving
QTc Interval, other method of correction
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
- UMLS CUI [1,3]
- C0205394
Beschrijving
Is this a repeat ECG?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0205341
Beschrijving
Specify reason ECG repeated
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0205341
- UMLS CUI [1,3]
- C0392360
Beschrijving
Specify other reason ECG repeated
Datatype
text
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0205341
- UMLS CUI [1,3]
- C0392360
- UMLS CUI [1,4]
- C0205394
Beschrijving
Result of the ECG
Datatype
integer
Alias
- UMLS CUI [1]
- C0438154
Beschrijving
Rhythm
Datatype
integer
Alias
- UMLS CUI [1]
- C0232187
Beschrijving
Specify other rhythm
Datatype
text
Alias
- UMLS CUI [1,1]
- C0232187
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschrijving
P-Wave Morphology
Datatype
integer
Alias
- UMLS CUI [1]
- C2216025
Beschrijving
Specify other ther P-Wave Morphology
Datatype
text
Alias
- UMLS CUI [1,1]
- C2216025
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschrijving
Conduction
Datatype
integer
Alias
- UMLS CUI [1]
- C0232217
Beschrijving
Specify other conduction
Datatype
text
Alias
- UMLS CUI [1,1]
- C0232217
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschrijving
Myocardial Infarction
Datatype
integer
Alias
- UMLS CUI [1]
- C0027051
Beschrijving
Specify other myocardial infarction
Datatype
text
Alias
- UMLS CUI [1,1]
- C0027051
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschrijving
Depolarisation/Repolarisation (QRS-T)
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1331539
- UMLS CUI [1,2]
- C0948857
Beschrijving
Enter Comment
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
Beschrijving
Other ECG abnormalities
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C0205394
Beschrijving
Specify other ECG abnormalities
Datatype
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])