ID
33523
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 information about the subjects 12-lead electrocardiogram. All ECGs will be recorder after 10 minutes rest in the semi-supine position. It should be filled out at screening visit. Unscheduled ECGs should be recorded whenever they have been performed 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
Mots-clés
Versions (4)
- 11/12/2018 11/12/2018 -
- 11/12/2018 11/12/2018 -
- 08/01/2019 08/01/2019 -
- 23/01/2019 23/01/2019 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
11 décembre 2018
DOI
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Licence
Creative Commons BY-NC 3.0
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Effect of Lamictal on Resting Motor Threshold Study-ID 107434
ECG
- StudyEvent: ODM
Description
12- Lead Electrocardiogram
Alias
- UMLS CUI-1
- C0430456
Description
Blood pressure
Type de données
integer
Alias
- UMLS CUI [1]
- C0005823
Description
If ECG abnormal and clinically significant, exclude
Type de données
integer
Alias
- UMLS CUI [1]
- C0438154
Description
ECG comment
Type de données
text
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0947611
Description
Unscheduled 12-Lead Electrocardiogram
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C3854240
Description
Actual Time
Type de données
time
Alias
- UMLS CUI [1]
- C0040223
Description
RR Value
Type de données
integer
Unités de mesure
- ms
Alias
- UMLS CUI [1]
- C0489636
Description
Tick only one
Type de données
integer
Alias
- UMLS CUI [1]
- C0438154
Description
Please enter reason for repeat of ECG.
Type de données
text
Alias
- UMLS CUI [1]
- C0947611
Description
Conclusion
Alias
- UMLS CUI-1
- C1707478
Similar models
ECG
- StudyEvent: ODM
C0600091 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
C3854240 (UMLS CUI-2)
C1552089 (UMLS CUI [1,2])
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