ID
33942
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 is for documentation of the measurement of vital signs in the semi-supine position. It should be filled out at each treatment period visit. 3 measurements will be taken predose on Day 1, the baseline will be considered the mean of the 3 measurements 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)
- 03/12/2018 03/12/2018 -
- 16/12/2018 16/12/2018 -
- 08/01/2019 08/01/2019 -
- 11/01/2019 11/01/2019 - Sarah Riepenhausen
Détendeur de droits
GlaxoSmithKline
Téléchargé le
8 janvier 2019
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY-NC 3.0
Modèle Commentaires :
Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.
Groupe Item commentaires pour :
Item commentaires pour :
Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.
Effect of Lamictal on Resting Motor Threshold Study-ID 107434
Semi-Supine Vital Signs (Treatment Period)
- StudyEvent: ODM
Description
Semi-supine Vital Signs
Alias
- UMLS CUI-1
- C0522019
- UMLS CUI-2
- C0518766
Description
Study Day
Type de données
integer
Alias
- UMLS CUI [1]
- C2826182
Description
3 measurements will be taken predose on Day 1, the baseline will be considered the mean of the 3 measurements
Type de données
text
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C2348563
Description
Date
Type de données
date
Alias
- UMLS CUI [1]
- C0011008
Description
Actual Time
Type de données
time
Alias
- UMLS CUI [1]
- C0040223
Description
To be measured after 10 minutes in semi-supine position.
Type de données
integer
Unités de mesure
- bpm
Alias
- UMLS CUI [1]
- C0232117
Description
To be measured after 10 minutes in semi-supine position.
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
To be measured after 10 minutes in semi-supine position.
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
Comments
Type de données
text
Alias
- UMLS CUI [1]
- C0947611
Description
Vital Abnormal
Type de données
boolean
Alias
- UMLS CUI [1]
- C0277804
Description
No = Asymptomatic
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0205341
- UMLS CUI [1,3]
- C0242485
Description
Clinical Staff Initials
Type de données
text
Alias
- UMLS CUI [1,1]
- C2986440
- UMLS CUI [1,2]
- C1552089
Description
Baseline Vital Sign
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C1442488
Description
Baseline = Mean measurement of triplicate Pre dose vital signs
Type de données
integer
Unités de mesure
- bpm
Alias
- UMLS CUI [1,1]
- C0232117
- UMLS CUI [1,2]
- C1442488
Description
Blood Pressure Systolic Baseline
Type de données
integer
Alias
- UMLS CUI [1]
- C0871470
Description
Blood Pressure Diastolic Baseline
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C1442488
Description
Mean calculated by
Type de données
text
Alias
- UMLS CUI [1,1]
- C2986440
- UMLS CUI [1,2]
- C0031831
Similar models
Semi-Supine Vital Signs (Treatment Period)
- StudyEvent: ODM
C0600091 (UMLS CUI [1,2])
C0518766 (UMLS CUI-2)
C0205341 (UMLS CUI [1,2])
C0242485 (UMLS CUI [1,3])
C1552089 (UMLS CUI [1,2])
C1442488 (UMLS CUI [1,2])
C1442488 (UMLS CUI [1,2])
C0031831 (UMLS CUI [1,2])