ID
33454
Description
Study ID: 107434 Clinical Study ID: NAP107434 Study Title: A randomised, double-blind, double-dummy, placebo controlled, three-way cross-over study to investigate the effect of single oral doses of 100 mg GW273225 (4030W92) and 325 mg LAMICTAL on resting motor threshold in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Study Link: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW273225 Trade Name: lamictal Study Indication: Bipolar Disorder This form contains informations about the subjects vital signs. The subject should be resting in semi-supine position for 10 minutes before each reading. It should be filled out at the screening visit and updated at each subsequent visit. Screening Visit: 28 days prior to first dosing. Treatment Period: The day before dosing, until 48h after dosing. Follow-Up: 14-21 days after last dose
Keywords
Versions (4)
- 12/9/18 12/9/18 -
- 12/9/18 12/9/18 -
- 1/8/19 1/8/19 -
- 1/11/19 1/11/19 - Sarah Riepenhausen
Copyright Holder
GlaxoSmithKline
Uploaded on
December 9, 2018
DOI
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License
Creative Commons BY-NC 3.0
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Effect of Lamictal on Resting Motor Threshold
Vital signs
- StudyEvent: ODM
Description
Vital Signs
Description
Actual Time
Data type
datetime
Alias
- UMLS CUI [1]
- C0040223
Description
Pulse Rate
Data type
integer
Measurement units
- bpm
Alias
- UMLS CUI [1]
- C0232117
Description
Blood pressure systolic
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
Blood pressure diastolic
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
Vital Signs Abnormal
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0205161
Description
If yes, please complete the unscheduled vitals form
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0205161
- UMLS CUI [2,1]
- C0205341
- UMLS CUI [2,2]
- C0242485
Description
Repeat if: - systolic pressure is <80mmHg or >150mmHg - diastolic pressure is <35mmHg and >105mmHg - pulse rate is outside of the range 35-100bpm
Data type
text
Description
Conclusion
Alias
- UMLS CUI-1
- C1707478
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Vital signs
- StudyEvent: ODM
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C0205161 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,2])
C0205341 (UMLS CUI [2,1])
C0242485 (UMLS CUI [2,2])
C1552089 (UMLS CUI [1,2])