ID

34389

Description

Efficacy and Safety Study of Udenafil in Patient With Pulmonary Arterial Hypertension(PAH); ODM derived from: https://clinicaltrials.gov/show/NCT01553721

Link

https://clinicaltrials.gov/show/NCT01553721

Keywords

  1. 1/17/19 1/17/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 17, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility Pulmonary Arterial Hypertension NCT01553721

Eligibility Pulmonary Arterial Hypertension NCT01553721

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
• subjects aged 18 and over who have any of the following diseases
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
primary pulmonary arterial hypertension
Description

Primary pulmonary arterial hypertension

Data type

boolean

Alias
UMLS CUI [1]
C4509207
secondary pulmonary arterial hypertension caused by connective tissue disease
Description

Secondary pulmonary arterial hypertension caused by Connective Tissue Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C3665995
UMLS CUI [1,2]
C0015127
UMLS CUI [1,3]
C0009782
[phase iib] pulmonary arterial hypertension caused by congenital heart disease(including eisenmenger syndrome)
Description

Pulmonary arterial hypertension caused by Congenital heart disease | Pulmonary arterial hypertension caused by Eisenmenger Syndrome

Data type

boolean

Alias
UMLS CUI [1,1]
C2973725
UMLS CUI [1,2]
C0015127
UMLS CUI [1,3]
C0152021
UMLS CUI [2,1]
C2973725
UMLS CUI [2,2]
C0015127
UMLS CUI [2,3]
C0013743
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects with pulmonary arterial hypertension caused by any etiology other than those specified in the inclusion criteria
Description

Pulmonary arterial hypertension | Etiology Except Inclusion criteria

Data type

boolean

Alias
UMLS CUI [1]
C2973725
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C1512693
bmi(body mass index) < 18.5kg/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
subjects with hypotension(sbp/dbp<90/50mmhg) or uncontrolled hypertension(sbp/dbp>170/100mmhg)
Description

Hypotension | Systolic Pressure | Diastolic blood pressure | Uncontrolled hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0020649
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
UMLS CUI [4]
C1868885
creatinine clearance ≤ 30ml/min
Description

Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1]
C0373595
history of non-arteritic anterior ischemic optic neuropathy(naion)
Description

Nonarteritic anterior ischemic optic neuropathy (NAION)

Data type

boolean

Alias
UMLS CUI [1]
C1852242

Similar models

Eligibility Pulmonary Arterial Hypertension NCT01553721

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
• subjects aged 18 and over who have any of the following diseases
boolean
C0001779 (UMLS CUI [1])
Primary pulmonary arterial hypertension
Item
primary pulmonary arterial hypertension
boolean
C4509207 (UMLS CUI [1])
Secondary pulmonary arterial hypertension caused by Connective Tissue Disease
Item
secondary pulmonary arterial hypertension caused by connective tissue disease
boolean
C3665995 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0009782 (UMLS CUI [1,3])
Pulmonary arterial hypertension caused by Congenital heart disease | Pulmonary arterial hypertension caused by Eisenmenger Syndrome
Item
[phase iib] pulmonary arterial hypertension caused by congenital heart disease(including eisenmenger syndrome)
boolean
C2973725 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0152021 (UMLS CUI [1,3])
C2973725 (UMLS CUI [2,1])
C0015127 (UMLS CUI [2,2])
C0013743 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Pulmonary arterial hypertension | Etiology Except Inclusion criteria
Item
subjects with pulmonary arterial hypertension caused by any etiology other than those specified in the inclusion criteria
boolean
C2973725 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C1512693 (UMLS CUI [2,3])
Body mass index
Item
bmi(body mass index) < 18.5kg/m2
boolean
C1305855 (UMLS CUI [1])
Hypotension | Systolic Pressure | Diastolic blood pressure | Uncontrolled hypertension
Item
subjects with hypotension(sbp/dbp<90/50mmhg) or uncontrolled hypertension(sbp/dbp>170/100mmhg)
boolean
C0020649 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
C1868885 (UMLS CUI [4])
Creatinine clearance measurement
Item
creatinine clearance ≤ 30ml/min
boolean
C0373595 (UMLS CUI [1])
Nonarteritic anterior ischemic optic neuropathy (NAION)
Item
history of non-arteritic anterior ischemic optic neuropathy(naion)
boolean
C1852242 (UMLS CUI [1])

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