ID
40834
Description
Study ID: 101468/902 Clinical Study ID: 101468/902 Study Title:A study to evaluate the effect of repeated oral doses of ropinirole on cardiac conduction as assessed by 12-lead electrocardiogram compared to placebo and single oral doses of moxifloxacin (Bayer) as a positive control. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome
Keywords
Versions (1)
- 5/21/20 5/21/20 -
Copyright Holder
GlaxoSmithKline
Uploaded on
May 21, 2020
DOI
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License
Creative Commons BY-NC 4.0
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Effect of ropinirole on cardiac conduction as assessed by 12-lead electrocardiogram (101468/902)
Dosing Details; ECG Monitoring; Safety ECG Monitoring
- StudyEvent: ODM
Description
Dosing Details
Alias
- UMLS CUI-1
- C0678766
- UMLS CUI-2
- C1522508
Description
Dosing Details - Study Time
Data type
time
Alias
- UMLS CUI [1,1]
- C0678766
- UMLS CUI [1,2]
- C1522508
- UMLS CUI [2,1]
- C2348563
- UMLS CUI [2,2]
- C0040223
Description
Dosing Details - Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0678766
- UMLS CUI [1,2]
- C1522508
- UMLS CUI [1,3]
- C0011008
Description
Dosing Details - Actual Time
Data type
time
Alias
- UMLS CUI [1,1]
- C0678766
- UMLS CUI [1,2]
- C1522508
- UMLS CUI [1,3]
- C0040223
Description
Dosing Details
Alias
- UMLS CUI-1
- C0678766
- UMLS CUI-2
- C1522508
Description
Dosing Details - Study Time
Data type
time
Alias
- UMLS CUI [1,1]
- C0678766
- UMLS CUI [1,2]
- C1522508
- UMLS CUI [2,1]
- C2348563
- UMLS CUI [2,2]
- C0040223
Description
Dosing Details - Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0678766
- UMLS CUI [1,2]
- C1522508
- UMLS CUI [1,3]
- C0011008
Description
Dosing Details - Actual Time
Data type
time
Alias
- UMLS CUI [1,1]
- C0678766
- UMLS CUI [1,2]
- C1522508
- UMLS CUI [1,3]
- C0040223
Description
Dose checked and administered by:
Data type
text
Alias
- UMLS CUI [1]
- C2348343
Description
Dose checked and witnessed by:
Data type
text
Alias
- UMLS CUI [1,1]
- C0682356
- UMLS CUI [1,2]
- C1283174
- UMLS CUI [1,3]
- C0178602
Description
ECG Monitoring - Supine
Alias
- UMLS CUI-1
- C1623258
- UMLS CUI-2
- C1283169
- UMLS CUI-3
- C0038846
Description
ECG Monitoring - Supine
Alias
- UMLS CUI-1
- C1623258
- UMLS CUI-2
- C1283169
- UMLS CUI-3
- C0038846
Description
ECG Monitoring - Supine - Study Time
Data type
integer
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C1283169
- UMLS CUI [1,3]
- C0038846
- UMLS CUI [2,1]
- C2348563
- UMLS CUI [2,2]
- C0040223
Description
ECG Monitoring - Supine - Date
Data type
date
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C1283169
- UMLS CUI [1,3]
- C0038846
- UMLS CUI [2]
- C0011008
Description
ECG Monitoring - Supine - Actual Time
Data type
time
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C1283169
- UMLS CUI [1,3]
- C0038846
- UMLS CUI [2]
- C0040223
Description
ECG Monitoring - Supine - ECG normal?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C1283169
- UMLS CUI [1,3]
- C0038846
- UMLS CUI [1,4]
- C0522054
Description
ECG Monitoring - Supine - Comments
Data type
text
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C1283169
- UMLS CUI [1,3]
- C0038846
- UMLS CUI [2]
- C0947611
Description
ECG Monitoring - Supine (Follow-Up)
Alias
- UMLS CUI-1
- C1623258
- UMLS CUI-2
- C1283169
- UMLS CUI-3
- C0038846
- UMLS CUI-4
- C1522577
Description
ECG Monitoring - Supine - Study Time
Data type
integer
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C1283169
- UMLS CUI [1,3]
- C0038846
- UMLS CUI [2,1]
- C2348563
- UMLS CUI [2,2]
- C0040223
Description
ECG Monitoring - Supine - Date
Data type
date
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C1283169
- UMLS CUI [1,3]
- C0038846
- UMLS CUI [2]
- C0011008
Description
ECG Monitoring - Supine - Actual Time
Data type
time
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C1283169
- UMLS CUI [1,3]
- C0038846
- UMLS CUI [2]
- C0040223
Description
ECG Monitoring - Supine - ECG normal?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C1283169
- UMLS CUI [1,3]
- C0038846
- UMLS CUI [1,4]
- C0522054
Description
ECG Monitoring - Supine - Comments
Data type
text
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C1283169
- UMLS CUI [1,3]
- C0038846
- UMLS CUI [2]
- C0947611
Description
Safety ECG Monitoring - Supine
Alias
- UMLS CUI-1
- C1623258
- UMLS CUI-2
- C1283169
- UMLS CUI-3
- C0038846
Description
ECG Monitoring - Supine - Study Time
Data type
integer
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C1283169
- UMLS CUI [1,3]
- C0038846
- UMLS CUI [2,1]
- C2348563
- UMLS CUI [2,2]
- C0040223
Description
ECG Monitoring - Supine - Date
Data type
date
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C1283169
- UMLS CUI [1,3]
- C0038846
- UMLS CUI [2]
- C0011008
Description
ECG Monitoring - Supine - Actual Time
Data type
time
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C1283169
- UMLS CUI [1,3]
- C0038846
- UMLS CUI [2]
- C0040223
Description
ECG Monitoring - Supine - ECG normal?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C1283169
- UMLS CUI [1,3]
- C0038846
- UMLS CUI [1,4]
- C0522054
Description
ECG Monitoring - Supine - Comments
Data type
text
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C1283169
- UMLS CUI [1,3]
- C0038846
- UMLS CUI [2]
- C0947611
Description
ECG Monitoring - Supine - Research Physician's Signature
Alias
- UMLS CUI-1
- C1623258
- UMLS CUI-2
- C1283169
- UMLS CUI-3
- C0038846
- UMLS CUI-4
- C1519316
- UMLS CUI-5
- C0031831
Description
Research Physician’s Signature
Data type
text
Alias
- UMLS CUI [1,1]
- C1519316
- UMLS CUI [1,2]
- C0031831
Description
Research Physician’s Signature - Date
Data type
date
Alias
- UMLS CUI [1,1]
- C1519316
- UMLS CUI [1,2]
- C0031831
- UMLS CUI [1,3]
- C0011008
Similar models
Dosing Details; ECG Monitoring; Safety ECG Monitoring
- StudyEvent: ODM
C1522508 (UMLS CUI [1,2])
C2348563 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
C1522508 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1522508 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C1522508 (UMLS CUI [1,2])
C2348563 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
C1522508 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1522508 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C1283174 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C1283169 (UMLS CUI-2)
C0038846 (UMLS CUI-3)
C0877248 (UMLS CUI [1,2])
C1283169 (UMLS CUI-2)
C0038846 (UMLS CUI-3)
C1283169 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,3])
C2348563 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
C1283169 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,3])
C0011008 (UMLS CUI [2])
C1283169 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,3])
C0040223 (UMLS CUI [2])
C1283169 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,3])
C0522054 (UMLS CUI [1,4])
C1283169 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,3])
C0947611 (UMLS CUI [2])
C1283169 (UMLS CUI-2)
C0038846 (UMLS CUI-3)
C1522577 (UMLS CUI-4)
C1283169 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,3])
C2348563 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
C1283169 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,3])
C0011008 (UMLS CUI [2])
C1283169 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,3])
C0040223 (UMLS CUI [2])
C1283169 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,3])
C0522054 (UMLS CUI [1,4])
C1283169 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,3])
C0947611 (UMLS CUI [2])
C1283169 (UMLS CUI-2)
C0038846 (UMLS CUI-3)
C1283169 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,3])
C2348563 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
C1283169 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,3])
C0011008 (UMLS CUI [2])
C1283169 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,3])
C0040223 (UMLS CUI [2])
C1283169 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,3])
C0522054 (UMLS CUI [1,4])
C1283169 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,3])
C0947611 (UMLS CUI [2])
C1283169 (UMLS CUI-2)
C0038846 (UMLS CUI-3)
C1519316 (UMLS CUI-4)
C0031831 (UMLS CUI-5)
C0031831 (UMLS CUI [1,2])
C0031831 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])