ID

29347

Beschrijving

A Study to Evaluate the Effect of Fimasartan on Pharmacokinetics, and the Safety of Digoxin in Healthy Male Volunteers; ODM derived from: https://clinicaltrials.gov/show/NCT00991783

Link

https://clinicaltrials.gov/show/NCT00991783

Trefwoorden

  1. 20-03-18 20-03-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

20 maart 2018

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0

Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Essential Hypertension NCT00991783

Eligibility Essential Hypertension NCT00991783

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
age: 20 - 40 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
sex: male
Beschrijving

Gender

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
body weight: greater than 55 kg
Beschrijving

Body Weight

Datatype

boolean

Alias
UMLS CUI [1]
C0005910
written informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
known allergy to fimasartan and digoxin
Beschrijving

Hypersensitivity Fimasartan | Digoxin allergy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2825622
UMLS CUI [2]
C0571956
existing cardiac or hematological diseases
Beschrijving

Heart Diseases | Hematological Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0018939
existing hepatic and renal diseases
Beschrijving

Liver diseases | Kidney Diseases

Datatype

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0022658
existing gastrointestinal diseases
Beschrijving

Gastrointestinal Diseases

Datatype

boolean

Alias
UMLS CUI [1]
C0017178
acute or chronic diseases which could affect drug absorption or metabolism history of any serious psychological disorder
Beschrijving

Disease Affecting Drug absorption | Chronic disease Affecting Drug absorption | Disease Affecting Drug metabolism | Chronic disease Affecting Drug metabolism | Mental disorders Serious

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0678745
UMLS CUI [2,1]
C0008679
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0678745
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0683140
UMLS CUI [4,1]
C0008679
UMLS CUI [4,2]
C0392760
UMLS CUI [4,3]
C0683140
UMLS CUI [5,1]
C0004936
UMLS CUI [5,2]
C0205404
positive drug or alcohol screening
Beschrijving

Substance Use Disorders Screening Positive

Datatype

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C0220908
UMLS CUI [1,3]
C1514241
smokers of 10 or more cigarettes per day 3 month ago
Beschrijving

Tobacco use Number of cigarettes per day

Datatype

boolean

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C3694146
participation in a clinical trial during the last 2 months prior to the start of the study
Beschrijving

Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1]
C2348568

Similar models

Eligibility Essential Hypertension NCT00991783

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age: 20 - 40 years
boolean
C0001779 (UMLS CUI [1])
Gender
Item
sex: male
boolean
C0079399 (UMLS CUI [1])
Body Weight
Item
body weight: greater than 55 kg
boolean
C0005910 (UMLS CUI [1])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Fimasartan | Digoxin allergy
Item
known allergy to fimasartan and digoxin
boolean
C0020517 (UMLS CUI [1,1])
C2825622 (UMLS CUI [1,2])
C0571956 (UMLS CUI [2])
Heart Diseases | Hematological Disease
Item
existing cardiac or hematological diseases
boolean
C0018799 (UMLS CUI [1])
C0018939 (UMLS CUI [2])
Liver diseases | Kidney Diseases
Item
existing hepatic and renal diseases
boolean
C0023895 (UMLS CUI [1])
C0022658 (UMLS CUI [2])
Gastrointestinal Diseases
Item
existing gastrointestinal diseases
boolean
C0017178 (UMLS CUI [1])
Disease Affecting Drug absorption | Chronic disease Affecting Drug absorption | Disease Affecting Drug metabolism | Chronic disease Affecting Drug metabolism | Mental disorders Serious
Item
acute or chronic diseases which could affect drug absorption or metabolism history of any serious psychological disorder
boolean
C0012634 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0678745 (UMLS CUI [1,3])
C0008679 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0678745 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0683140 (UMLS CUI [3,3])
C0008679 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C0683140 (UMLS CUI [4,3])
C0004936 (UMLS CUI [5,1])
C0205404 (UMLS CUI [5,2])
Substance Use Disorders Screening Positive
Item
positive drug or alcohol screening
boolean
C0038586 (UMLS CUI [1,1])
C0220908 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
Tobacco use Number of cigarettes per day
Item
smokers of 10 or more cigarettes per day 3 month ago
boolean
C0543414 (UMLS CUI [1,1])
C3694146 (UMLS CUI [1,2])
Study Subject Participation Status
Item
participation in a clinical trial during the last 2 months prior to the start of the study
boolean
C2348568 (UMLS CUI [1])

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

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