ID

21888

Description

Pulmonary Artery Remodelling With Bosentan; ODM derived from: https://clinicaltrials.gov/show/NCT00595049

Link

https://clinicaltrials.gov/show/NCT00595049

Keywords

Versions (2)
  1. 5/6/17 5/6/17 -
  2. 9/20/21 9/20/21 -
Uploaded on

May 6, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension, Pulmonary NCT00595049

English

Eligibility Hypertension, Pulmonary NCT00595049

1 forms  
Criteria
Description

Criteria

symptomatic (modified nyha class iii) ipah or pah-ssc·
Description

idiopathic or systemic sclerosis associated pulmonary hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0152171
UMLS CUI [2,1]
C0036421
UMLS CUI [2,2]
C0020542
pah confirmed by right heart catheterization performed within 3 months before enrolment mpap > 25 mmhg, pcwp < 15 mmhg and pvr > 3 mmhg/l/min.
Description

pulmonary artery hypertension by heart catheterization, mpap, pcwp, pvr

Data type

boolean

Alias
UMLS CUI [1,1]
C0020542
UMLS CUI [1,2]
C0018795
UMLS CUI [1,3]
C3854605
UMLS CUI [1,4]
C0086879
UMLS CUI [1,5]
C0456261
women of childbearing potential must have a negative pre-treatment pregnancy test and use a reliable method of contraception during study treatment and for 3 months after study treatment termination.
Description

pregnancy, contraception

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0700589
bosentan naïve patients
Description

bosentan

Data type

boolean

Alias
UMLS CUI [1]
C0252643
exclusion criteria : · pah other than ipah or pah-ssc
Description

exclusion criteria pulmonary hypertension other than idiopathic or systemic sclerosis associated

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0020542
UMLS CUI [1,3]
C0152171
UMLS CUI [1,4]
C0036421
significant vasoreactivity during right heart catheterization defined as a fall in mpap to < 40 mmhg with a decrease >= 10 mmhg and with a normal cardiac index (>= 2.5 l/min.m2)· severe obstructive lung disease: fev1/fvc < 0.5
Description

vasoreactivity during right heart catheterization, mpap, cardiac index, fev1/fvc

Data type

boolean

Alias
UMLS CUI [1,1]
C0189896
UMLS CUI [1,2]
C4076759
UMLS CUI [1,3]
C3854605
UMLS CUI [2]
C0428776
UMLS CUI [3,1]
C0600260
UMLS CUI [3,2]
C0016529
severe restrictive lung disease: tlc < 0.7 of normal predicted value
Description

restrictive lung disease, total lung capacity

Data type

boolean

Alias
UMLS CUI [1,1]
C0085581
UMLS CUI [1,2]
C0040509
hemoglobin <75% of the lower limit of the normal range· systolic blood pressure < 85 mmhg
Description

hemoglobin, systolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C0019046
UMLS CUI [2]
C0871470
body weight < 40 kg
Description

body weight

Data type

boolean

Alias
UMLS CUI [1]
C0005910
pregnancy or breast-feeding
Description

pregnancy, breast feeding

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
moderate to severe hepatic impairment, i.e., child-pugh class b or c.
Description

hepatic impairment child-pugh classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0948807
UMLS CUI [1,2]
C2347612
baseline aminotransferases, i.e., aspartate aminotransferases (ast) and/or alanine aminotransferases (alt) > 3 times the upper limit of the normal (uln) range.
Description

aminotransferases

Data type

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
treatment for ipah or pah-ssc within 1 month before start of study treatment, excluding warfarin and acute administration of vasodilators for vascular reactivity testing during heart catheterization.
Description

pulmonary hypertension treatment, warfarin, vasodilators during heart catheterization

Data type

boolean

Alias
UMLS CUI [1,1]
C0020542
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0043031
UMLS CUI [1,4]
C0018795
UMLS CUI [1,5]
C0042402
treatment with epoprostenol or other prostacyclin analogs for ipah or pah-ssc within 1 month before start of study treatment
Description

epoprostenol

Data type

boolean

Alias
UMLS CUI [1]
C0033567
treatment with glibenclamide (glyburide), fluconazole ketoconazole or ritonavir within 1 week before start of study treatment.
Description

glibenclamide, fluconazole, ketoconazole, ritonavir

Data type

boolean

Alias
UMLS CUI [1]
C0017628
UMLS CUI [2]
C0016277
UMLS CUI [3]
C0022625
UMLS CUI [4]
C0292818
current treatment with cyclosporine a or tacrolimus
Description

cyclosporine, tacrolimus

Data type

boolean

Alias
UMLS CUI [1]
C0010592
UMLS CUI [2]
C0085149
hypersensitivity to bosentan or any of the excipients of its formulation.
Description

bosentan hypersensitivity

Data type

boolean

Alias
UMLS CUI [1,1]
C0252643
UMLS CUI [1,2]
C0020517
patient who received an investigational drug (such as sildenafil) within 3 months before start of study treatment
Description

investigational drug

Data type

boolean

Alias
UMLS CUI [1]
C0013230
conditions that prevent compliance with the protocol or adherence to therapy.
Description

compliance

Data type

boolean

Alias
UMLS CUI [1]
C1321605
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Similar models

Eligibility Hypertension, Pulmonary NCT00595049

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
idiopathic or systemic sclerosis associated pulmonary hypertension
Item
symptomatic (modified nyha class iii) ipah or pah-ssc·
boolean
C0152171 (UMLS CUI [1])
C0036421 (UMLS CUI [2,1])
C0020542 (UMLS CUI [2,2])
pulmonary artery hypertension by heart catheterization, mpap, pcwp, pvr
Item
pah confirmed by right heart catheterization performed within 3 months before enrolment mpap > 25 mmhg, pcwp < 15 mmhg and pvr > 3 mmhg/l/min.
boolean
C0020542 (UMLS CUI [1,1])
C0018795 (UMLS CUI [1,2])
C3854605 (UMLS CUI [1,3])
C0086879 (UMLS CUI [1,4])
C0456261 (UMLS CUI [1,5])
pregnancy, contraception
Item
women of childbearing potential must have a negative pre-treatment pregnancy test and use a reliable method of contraception during study treatment and for 3 months after study treatment termination.
boolean
C0032961 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
bosentan
Item
bosentan naïve patients
boolean
C0252643 (UMLS CUI [1])
exclusion criteria pulmonary hypertension other than idiopathic or systemic sclerosis associated
Item
exclusion criteria : · pah other than ipah or pah-ssc
boolean
C0680251 (UMLS CUI [1,1])
C0020542 (UMLS CUI [1,2])
C0152171 (UMLS CUI [1,3])
C0036421 (UMLS CUI [1,4])
vasoreactivity during right heart catheterization, mpap, cardiac index, fev1/fvc
Item
significant vasoreactivity during right heart catheterization defined as a fall in mpap to < 40 mmhg with a decrease >= 10 mmhg and with a normal cardiac index (>= 2.5 l/min.m2)· severe obstructive lung disease: fev1/fvc < 0.5
boolean
C0189896 (UMLS CUI [1,1])
C4076759 (UMLS CUI [1,2])
C3854605 (UMLS CUI [1,3])
C0428776 (UMLS CUI [2])
C0600260 (UMLS CUI [3,1])
C0016529 (UMLS CUI [3,2])
restrictive lung disease, total lung capacity
Item
severe restrictive lung disease: tlc < 0.7 of normal predicted value
boolean
C0085581 (UMLS CUI [1,1])
C0040509 (UMLS CUI [1,2])
hemoglobin, systolic blood pressure
Item
hemoglobin <75% of the lower limit of the normal range· systolic blood pressure < 85 mmhg
boolean
C0019046 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
body weight
Item
body weight < 40 kg
boolean
C0005910 (UMLS CUI [1])
pregnancy, breast feeding
Item
pregnancy or breast-feeding
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
hepatic impairment child-pugh classification
Item
moderate to severe hepatic impairment, i.e., child-pugh class b or c.
boolean
C0948807 (UMLS CUI [1,1])
C2347612 (UMLS CUI [1,2])
aminotransferases
Item
baseline aminotransferases, i.e., aspartate aminotransferases (ast) and/or alanine aminotransferases (alt) > 3 times the upper limit of the normal (uln) range.
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
pulmonary hypertension treatment, warfarin, vasodilators during heart catheterization
Item
treatment for ipah or pah-ssc within 1 month before start of study treatment, excluding warfarin and acute administration of vasodilators for vascular reactivity testing during heart catheterization.
boolean
C0020542 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0043031 (UMLS CUI [1,3])
C0018795 (UMLS CUI [1,4])
C0042402 (UMLS CUI [1,5])
epoprostenol
Item
treatment with epoprostenol or other prostacyclin analogs for ipah or pah-ssc within 1 month before start of study treatment
boolean
C0033567 (UMLS CUI [1])
glibenclamide, fluconazole, ketoconazole, ritonavir
Item
treatment with glibenclamide (glyburide), fluconazole ketoconazole or ritonavir within 1 week before start of study treatment.
boolean
C0017628 (UMLS CUI [1])
C0016277 (UMLS CUI [2])
C0022625 (UMLS CUI [3])
C0292818 (UMLS CUI [4])
cyclosporine, tacrolimus
Item
current treatment with cyclosporine a or tacrolimus
boolean
C0010592 (UMLS CUI [1])
C0085149 (UMLS CUI [2])
bosentan hypersensitivity
Item
hypersensitivity to bosentan or any of the excipients of its formulation.
boolean
C0252643 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
investigational drug
Item
patient who received an investigational drug (such as sildenafil) within 3 months before start of study treatment
boolean
C0013230 (UMLS CUI [1])
compliance
Item
conditions that prevent compliance with the protocol or adherence to therapy.
boolean
C1321605 (UMLS CUI [1])
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