ID
44519
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 (3)
- 5/19/20 5/19/20 -
- 5/20/20 5/20/20 -
- 9/27/21 9/27/21 -
Copyright Holder
GlaxoSmithKline
Uploaded on
September 27, 2021
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)
Pharmacogenetic Research; Prior Medication; Baseline Signs and Symptoms
Description
Pharmacogenetic Research
Alias
- UMLS CUI-1
- C0031325
Description
Has informed consent been obtained for Pharmacogenetic Research?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C2347500
Description
If informed consent has been obtained for Pharmacogenetic Research, record date
Data type
date
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C2347500
- UMLS CUI [1,3]
- C0011008
Description
If informed consent has not been obtained for Pharmacogenetic Research, check one reason
Data type
integer
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C2347500
- UMLS CUI [1,3]
- C2826287
Description
If other reason for informed consent has not been obtained for Pharmacogenetic Research, specify
Data type
text
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C2347500
- UMLS CUI [1,3]
- C2826287
- UMLS CUI [2,1]
- C0205394
- UMLS CUI [2,2]
- C2348235
Description
Has a blood sample been collected for Pharmacogenetic Research?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0005834
Description
If a blood sample has been collected for Pharmacogenetic Research, record date
Data type
date
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0005834
- UMLS CUI [1,3]
- C0011008
Description
Has this subject withdrawn consent for Pharmacogenetic Research?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0021430
- UMLS CUI [1,3]
- C2349954
Description
Has a request been made for sample destruction?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1948029
- UMLS CUI [1,2]
- C0178913
- UMLS CUI [1,3]
- C1272683
Description
If a request has been made for sample destruction, check one reason
Data type
integer
Alias
- UMLS CUI [1,1]
- C1948029
- UMLS CUI [1,2]
- C0178913
- UMLS CUI [1,3]
- C1272683
- UMLS CUI [1,4]
- C0566251
Description
If other reason for request for sample destruction, specify
Data type
text
Alias
- UMLS CUI [1,1]
- C1948029
- UMLS CUI [1,2]
- C0178913
- UMLS CUI [1,3]
- C1272683
- UMLS CUI [1,4]
- C0566251
- UMLS CUI [2,1]
- C0205394
- UMLS CUI [2,2]
- C2348235
Description
Prior Medication
Alias
- UMLS CUI-1
- C2826257
Description
Has the subject taken any medication within 1 week PRIOR to the first dose of study medication?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2826257
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C3174092
- UMLS CUI [1,4]
- C0205435
Description
Prior Medication
Alias
- UMLS CUI-1
- C2826257
Description
Trade Name preferred
Data type
text
Alias
- UMLS CUI [1]
- C0013227
Description
e.g. 500 mg
Data type
text
Alias
- UMLS CUI [1]
- C1960417
Description
(e.g.BID,PRN)
Data type
text
Alias
- UMLS CUI [1]
- C3476109
Description
Medication Route
Data type
text
Alias
- UMLS CUI [1]
- C0013153
Description
Medication Indication
Data type
text
Alias
- UMLS CUI [1,1]
- C3146298
- UMLS CUI [1,2]
- C0013227
Description
eg.6 years
Data type
text
Alias
- UMLS CUI [1]
- C0444921
Description
Medication End Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Description
Medication continuing at end of study?
Data type
boolean
Alias
- UMLS CUI [1]
- C1553904
Description
Baseline Signs and Symptoms
Alias
- UMLS CUI-1
- C0037088
- UMLS CUI-2
- C1442488
Description
Baseline Sign/ Symptom
Data type
text
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C1442488
Description
Signs/ Symptoms Onset Date and Time
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C0574845
- UMLS CUI [1,3]
- C0449244
Description
(If ongoing please leave blank)
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [1,3]
- C1522314
Description
Signs/ Symptoms Outcome
Data type
integer
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C1547647
Description
Signs/ Symptoms Event Course
Data type
integer
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C0750729
- UMLS CUI [1,3]
- C0441471
Description
If intermittent Course, record number of episodes
Data type
integer
Alias
- UMLS CUI [1,1]
- C0750729
- UMLS CUI [1,2]
- C0205267
- UMLS CUI [1,3]
- C4086638
Description
maximum
Data type
integer
Alias
- UMLS CUI [1]
- C0518690
Description
Relationship to study procedures performed prior to randomisation
Data type
integer
Alias
- UMLS CUI [1,1]
- C2700391
- UMLS CUI [1,2]
- C0439849
- UMLS CUI [1,3]
- C0034656
Description
Signs/ Symptoms Corrective Therapy
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C0087111
Description
Was subject withdrawn due to this event?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0877248
Description
Baseline Signs and Symptoms - Investigator's Signature
Alias
- UMLS CUI-1
- C0037088
- UMLS CUI-2
- C1442488
- UMLS CUI-3
- C2346576
Similar models
Pharmacogenetic Research; Prior Medication; Baseline Signs and Symptoms
C2347500 (UMLS CUI [1,2])
C2347500 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C2347500 (UMLS CUI [1,2])
C2826287 (UMLS CUI [1,3])
C2347500 (UMLS CUI [1,2])
C2826287 (UMLS CUI [1,3])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
C0005834 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0021430 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,3])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
C0013230 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
C0205435 (UMLS CUI [1,4])
C0013227 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C1442488 (UMLS CUI-2)
C1442488 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
C0449244 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
C1547647 (UMLS CUI [1,2])
C0750729 (UMLS CUI [1,2])
C0441471 (UMLS CUI [1,3])
C0205267 (UMLS CUI [1,2])
C4086638 (UMLS CUI [1,3])
C0439849 (UMLS CUI [1,2])
C0034656 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
C1442488 (UMLS CUI-2)
C2346576 (UMLS CUI-3)
C0011008 (UMLS CUI [1,2])