ID
44519
Beskrivning
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
Nyckelord
Versioner (3)
- 2020-05-19 2020-05-19 -
- 2020-05-20 2020-05-20 -
- 2021-09-27 2021-09-27 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
27 september 2021
DOI
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Licens
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
Beskrivning
Pharmacogenetic Research
Alias
- UMLS CUI-1
- C0031325
Beskrivning
Has informed consent been obtained for Pharmacogenetic Research?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C2347500
Beskrivning
If informed consent has been obtained for Pharmacogenetic Research, record date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C2347500
- UMLS CUI [1,3]
- C0011008
Beskrivning
If informed consent has not been obtained for Pharmacogenetic Research, check one reason
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C2347500
- UMLS CUI [1,3]
- C2826287
Beskrivning
If other reason for informed consent has not been obtained for Pharmacogenetic Research, specify
Datatyp
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
Beskrivning
Has a blood sample been collected for Pharmacogenetic Research?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0005834
Beskrivning
If a blood sample has been collected for Pharmacogenetic Research, record date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0005834
- UMLS CUI [1,3]
- C0011008
Beskrivning
Has this subject withdrawn consent for Pharmacogenetic Research?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0021430
- UMLS CUI [1,3]
- C2349954
Beskrivning
Has a request been made for sample destruction?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1948029
- UMLS CUI [1,2]
- C0178913
- UMLS CUI [1,3]
- C1272683
Beskrivning
If a request has been made for sample destruction, check one reason
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1948029
- UMLS CUI [1,2]
- C0178913
- UMLS CUI [1,3]
- C1272683
- UMLS CUI [1,4]
- C0566251
Beskrivning
If other reason for request for sample destruction, specify
Datatyp
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
Beskrivning
Prior Medication
Alias
- UMLS CUI-1
- C2826257
Beskrivning
Has the subject taken any medication within 1 week PRIOR to the first dose of study medication?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2826257
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C3174092
- UMLS CUI [1,4]
- C0205435
Beskrivning
Prior Medication
Alias
- UMLS CUI-1
- C2826257
Beskrivning
Trade Name preferred
Datatyp
text
Alias
- UMLS CUI [1]
- C0013227
Beskrivning
e.g. 500 mg
Datatyp
text
Alias
- UMLS CUI [1]
- C1960417
Beskrivning
(e.g.BID,PRN)
Datatyp
text
Alias
- UMLS CUI [1]
- C3476109
Beskrivning
Medication Route
Datatyp
text
Alias
- UMLS CUI [1]
- C0013153
Beskrivning
Medication Indication
Datatyp
text
Alias
- UMLS CUI [1,1]
- C3146298
- UMLS CUI [1,2]
- C0013227
Beskrivning
eg.6 years
Datatyp
text
Alias
- UMLS CUI [1]
- C0444921
Beskrivning
Medication End Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Beskrivning
Medication continuing at end of study?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1553904
Beskrivning
Baseline Signs and Symptoms
Alias
- UMLS CUI-1
- C0037088
- UMLS CUI-2
- C1442488
Beskrivning
Baseline Sign/ Symptom
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C1442488
Beskrivning
Signs/ Symptoms Onset Date and Time
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C0574845
- UMLS CUI [1,3]
- C0449244
Beskrivning
(If ongoing please leave blank)
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [1,3]
- C1522314
Beskrivning
Signs/ Symptoms Outcome
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C1547647
Beskrivning
Signs/ Symptoms Event Course
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C0750729
- UMLS CUI [1,3]
- C0441471
Beskrivning
If intermittent Course, record number of episodes
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0750729
- UMLS CUI [1,2]
- C0205267
- UMLS CUI [1,3]
- C4086638
Beskrivning
maximum
Datatyp
integer
Alias
- UMLS CUI [1]
- C0518690
Beskrivning
Relationship to study procedures performed prior to randomisation
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C2700391
- UMLS CUI [1,2]
- C0439849
- UMLS CUI [1,3]
- C0034656
Beskrivning
Signs/ Symptoms Corrective Therapy
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C0087111
Beskrivning
Was subject withdrawn due to this event?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0877248
Beskrivning
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])