ID
33453
Beskrivning
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
Nyckelord
Versioner (4)
- 2018-12-09 2018-12-09 -
- 2018-12-09 2018-12-09 -
- 2019-01-08 2019-01-08 -
- 2019-01-11 2019-01-11 - Sarah Riepenhausen
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
9 december 2018
DOI
För en begäran logga in.
Licens
Creative Commons BY-NC 3.0
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
Itemgroup-kommentar för :
Item-kommentar för :
Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.
Effect of Lamictal on Resting Motor Threshold
Vital signs
- StudyEvent: ODM
Beskrivning
Vital Signs
Beskrivning
Actual Time
Datatyp
datetime
Alias
- UMLS CUI [1]
- C0040223
Beskrivning
Pulse Rate
Datatyp
integer
Måttenheter
- bpm
Alias
- UMLS CUI [1]
- C0232117
Beskrivning
Blood pressure systolic
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beskrivning
Blood pressure diastolic
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beskrivning
Vital Signs Abnormal
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0205161
Beskrivning
If yes, please complete the unscheduled vitals form
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0205161
- UMLS CUI [2,1]
- C0205341
- UMLS CUI [2,2]
- C0242485
Beskrivning
Repeat if: - systolic pressure is <80mmHg or >150mmHg - diastolic pressure is <35mmHg and >105mmHg - pulse rate is outside of the range 35-100bpm
Datatyp
text
Beskrivning
Conclusion
Alias
- UMLS CUI-1
- C1707478
Similar models
Vital signs
- StudyEvent: ODM
C0600091 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
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])