ID
40876
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)
- 5/29/20 5/29/20 -
Copyright Holder
GlaxoSmithKline
Uploaded on
May 29, 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)
Follow-Up - Pregnancy Information; Study Conclusion; Investigator's Statement; General Comments
Description
Pregnancy Information
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Description
Study Conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
Description
If ’NO’, mark the one most appropriate category
Data type
boolean
Alias
- UMLS CUI [1]
- C2348577
Description
If the subject did not complete the study as planned, mark the most appropriate category
Data type
integer
Alias
- UMLS CUI [1,1]
- C2348577
- UMLS CUI [1,2]
- C0683312
Description
If other reason for not completing the study, specify
Data type
text
Alias
- UMLS CUI [1,1]
- C2348577
- UMLS CUI [1,2]
- C3840932
- UMLS CUI [1,3]
- C2348235
Description
Comments on reason for withdrawal:
Data type
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0392360
Description
Date of Withdrawal:
Data type
date
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0011008
Description
Time of Withdrawal:
Data type
time
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0040223
Description
Date of Final Dose:
Data type
date
Alias
- UMLS CUI [1]
- C1762893
Description
Time of Final Dose:
Data type
time
Alias
- UMLS CUI [1]
- C0946444
Description
Investigator's Statement
Alias
- UMLS CUI-1
- C0008961
- UMLS CUI-2
- C1710187
Description
Check all Adverse Event forms are up to date and complete
Data type
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0920316
- UMLS CUI [1,3]
- C0205197
Description
Check that the Concomitant Medication form is up to date
Data type
integer
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0920316
- UMLS CUI [1,3]
- C0237400
Description
Check that all appropriate pages are signed (thus indicating completion) and dated
Data type
integer
Alias
- UMLS CUI [1,1]
- C0805732
- UMLS CUI [1,2]
- C1283174
Description
Check that laboratory results are included
Data type
integer
Alias
- UMLS CUI [1,1]
- C1254595
- UMLS CUI [1,2]
- C0920316
Description
I certify that the observtions and findings are recorded correctly and completely in this CRF.
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
Date
Data type
date
Alias
- UMLS CUI [1]
- C0011008
Description
General Comments
Alias
- UMLS CUI-1
- C0947611
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Follow-Up - Pregnancy Information; Study Conclusion; Investigator's Statement; General Comments
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C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
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C0920316 (UMLS CUI [1,2])