ID

29344

Description

Study to Compare and Assess the Safety and Pharmacokinetic Characteristics After Oral Administration of Fimasartan (BR-A-657∙K) in Healthy Elderly and Young Male Volunteers; ODM derived from: https://clinicaltrials.gov/show/NCT00937534

Link

https://clinicaltrials.gov/show/NCT00937534

Keywords

  1. 3/20/18 3/20/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 20, 2018

DOI

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License

Creative Commons BY 4.0

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Eligibility Essential Hypertension NCT00937534

Eligibility Essential Hypertension NCT00937534

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
young: 19-45 years
Description

Young Adult | Age

Data type

boolean

Alias
UMLS CUI [1]
C0238598
UMLS CUI [2]
C0001779
elderly: more than 65 years
Description

Elderly | Age

Data type

boolean

Alias
UMLS CUI [1]
C0001792
UMLS CUI [2]
C0001779
sex: male
Description

Gender

Data type

boolean

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

Body Weight

Data type

boolean

Alias
UMLS CUI [1]
C0005910
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with contraindication to angiotensin ii receptor antagonist.
Description

Medical contraindication Angiotensin II receptor antagonist

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0521942
patients with a history of liver, renal, gastrointestinal, hematological or cardiac diseases
Description

Liver diseases | Kidney Diseases | Gastrointestinal Diseases | Hematological Disease | Heart Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0022658
UMLS CUI [3]
C0017178
UMLS CUI [4]
C0018939
UMLS CUI [5]
C0018799
patients with history or diseases which might affect absorption of the drug
Description

Medical History Affecting Absorption Investigational New Drugs | Disease Affecting Absorption Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0237442
UMLS CUI [1,4]
C0013230
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0237442
UMLS CUI [2,4]
C0013230
patients with hiv, type b or c hepatitis
Description

HIV Infection | Hepatitis B | Hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
smokers of 20 or more cigarettes per day
Description

Tobacco use Number of cigarettes per day

Data type

boolean

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C3694146

Similar models

Eligibility Essential Hypertension NCT00937534

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age
boolean
C0001779 (UMLS CUI [1])
Young Adult | Age
Item
young: 19-45 years
boolean
C0238598 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Elderly | Age
Item
elderly: more than 65 years
boolean
C0001792 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Gender
Item
sex: male
boolean
C0079399 (UMLS CUI [1])
Body Weight
Item
body weight: greater than 55 kg
boolean
C0005910 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Angiotensin II receptor antagonist
Item
patients with contraindication to angiotensin ii receptor antagonist.
boolean
C1301624 (UMLS CUI [1,1])
C0521942 (UMLS CUI [1,2])
Liver diseases | Kidney Diseases | Gastrointestinal Diseases | Hematological Disease | Heart Diseases
Item
patients with a history of liver, renal, gastrointestinal, hematological or cardiac diseases
boolean
C0023895 (UMLS CUI [1])
C0022658 (UMLS CUI [2])
C0017178 (UMLS CUI [3])
C0018939 (UMLS CUI [4])
C0018799 (UMLS CUI [5])
Medical History Affecting Absorption Investigational New Drugs | Disease Affecting Absorption Investigational New Drugs
Item
patients with history or diseases which might affect absorption of the drug
boolean
C0262926 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0237442 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
C0012634 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0237442 (UMLS CUI [2,3])
C0013230 (UMLS CUI [2,4])
HIV Infection | Hepatitis B | Hepatitis C
Item
patients with hiv, type b or c hepatitis
boolean
C0019693 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Tobacco use Number of cigarettes per day
Item
smokers of 20 or more cigarettes per day
boolean
C0543414 (UMLS CUI [1,1])
C3694146 (UMLS CUI [1,2])

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