ID

21929

Description

The present pharmacokinetic study is designed to assess the pharmacokinetics of RSG XR as monotherapy in patients with mild Alzheimer's disease (AD) as such information will not be obtained from the current phase III trials . The study aims to enroll fourteen patients (seven of each APOE genotype). Each patient will receive a single oral dose of 4mg of RSG XR in the morning under fasted conditions and PK samples will be taken up to 36h. GSK Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT00688207?term=NCT00688207&rank=1

Lien

https://clinicaltrials.gov/ct2/show/NCT00688207?term=NCT00688207&rank=1

Mots-clés

Versions (2)
  1. 09/05/2017 09/05/2017 -
  2. 22/05/2017 22/05/2017 -
Téléchargé le

9 mai 2017

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.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

Study Day 12-Lead ECG Mild Alzheimer's Disease to Assess the of Extended Release Formulation of Rosiglitazone (RSG XR) NCT00688207 / GSK-AVA109941

Anglais

Study Day 12-Lead ECG Mild Alzheimer's Disease to Assess the of Extended Release Formulation of Rosiglitazone (RSG XR) NCT00688207 / GSK-AVA109941

1 Formulaires  
12-Lead ECG
Description

12-Lead ECG

Alias
UMLS CUI-1
C0430456
ECG Number
Description

id

Type de données

text

Alias
UMLS CUI [1,1]
C1300638
UMLS CUI [1,2]
C0180600
Start date of ECG
Description

Start date of ECG

Type de données

date

Unités de mesure
  • Day Month Year
Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0013798
Day Month Year
Planned Relative Time
Description

Planned Relative Time

Type de données

text

Alias
UMLS CUI [1]
C0439564
Start Time of ECG
Description

Start Time of ECG

Type de données

time

Unités de mesure
  • Hr : Min
Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C0013798
Hr : Min
Heart Rate
Description

Heart Rate

Type de données

float

Unités de mesure
  • Beats/min
Alias
UMLS CUI [1]
C0018810
Beats/min
PR Interval
Description

PR Interval

Type de données

time

Unités de mesure
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS Duration
Description

QRS Duration

Type de données

time

Unités de mesure
  • Hr : Min
Alias
UMLS CUI [1]
C0429025
Hr : Min
Uncorrected QT Interval
Description

Uncorrected QT Interval

Type de données

time

Unités de mesure
  • Hr : Min
Alias
UMLS CUI [1]
C1287082
Hr : Min
QTc interval
Description

QTc interval

Type de données

time

Unités de mesure
  • Hr : Min
Alias
UMLS CUI [1]
C0489625
Hr : Min
Result of the ECG (enter Code for result from following list) *Complete the Non-Serious Adverse Events (AE) or Serious Adverse Event (SAE) page(s) if clinically significant abnormalities meet the protocol definition for an AE or SAE. Complete the additional ECG Abnormalities page if clinically significant abnormalities are present.
Description

Result of the ECG

Type de données

integer

Alias
UMLS CUI [1]
C0438154
Retour au début de la page

Similar models

Study Day 12-Lead ECG Mild Alzheimer's Disease to Assess the of Extended Release Formulation of Rosiglitazone (RSG XR) NCT00688207 / GSK-AVA109941

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
12-Lead ECG
C0430456 (UMLS CUI-1)
Item
ECG Number
text
C1300638 (UMLS CUI [1,1])
C0180600 (UMLS CUI [1,2])
id
Code List
ECG Number
CL Item
ECG 1 (1)
CL Item
ECG 2 (2)
CL Item
ECG 3 (3)
CL Item
ECG 4 (ECG 4)
CL Item
ECG 5 (ECG 5)
CL Item
ECG 6 (ECG 6)
CL Item
ECG 7 (ECG 7)
CL Item
ECG 8 (ECG 8)
Start date of ECG
Item
Start date of ECG
date
C0808070 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
Item
Planned Relative Time
text
C0439564 (UMLS CUI [1])
Planned Relative Time
Code List
Planned Relative Time
CL Item
Pre-Dose (1)
CL Item
12 hrs (12 hrs)
CL Item
24 hrs (24 hrs)
CL Item
36 hrs (36 hrs)
CL Item
Unscheduled (Unscheduled)
CL Item
Unscheduled (Unscheduled)
CL Item
Unscheduled (Unscheduled)
CL Item
Unscheduled (Unscheduled)
Start Time of ECG
Item
Start Time of ECG
time
C1301880 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
Heart Rate
Item
Heart Rate
float
C0018810 (UMLS CUI [1])
PR Interval
Item
PR Interval
time
C0429087 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
time
C0429025 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
time
C1287082 (UMLS CUI [1])
QTc interval
Item
QTc interval
time
C0489625 (UMLS CUI [1])
Item
Result of the ECG (enter Code for result from following list) *Complete the Non-Serious Adverse Events (AE) or Serious Adverse Event (SAE) page(s) if clinically significant abnormalities meet the protocol definition for an AE or SAE. Complete the additional ECG Abnormalities page if clinically significant abnormalities are present.
integer
C0438154 (UMLS CUI [1])
Result of the ECG
Code List
Result of the ECG (enter Code for result from following list) *Complete the Non-Serious Adverse Events (AE) or Serious Adverse Event (SAE) page(s) if clinically significant abnormalities meet the protocol definition for an AE or SAE. Complete the additional ECG Abnormalities page if clinically significant abnormalities are present.
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant (2)
CL Item
Abnormal - clinically significant* (3)
CL Item
No result (not available) (4)
Retour au début de la page 

Contact

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Aide

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial