ID

19076

Description

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess Safety and Efficacy of Ambrisentan in Subjects With Pulmonary Arterial Hypertension.; ODM derived from: https://clinicaltrials.gov/show/NCT00423202

Link

https://clinicaltrials.gov/show/NCT00423202

Keywords

  1. 12/4/16 12/4/16 -
Uploaded on

December 4, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Pulmonary Arterial Hypertension NCT00423202

Eligibility Pulmonary Arterial Hypertension NCT00423202

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
18 years of age and older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
current diagnosis of either pph or pah secondary to the scleroderma spectrum of disease, systemic lupus erythematosus, anorexigen use, or hiv infection at the screening visit
Description

Idiopathic pulmonary hypertension Secondary to Scleroderma | Pulmonary arterial hypertension Secondary to Scleroderma | Lupus Erythematosus, Systemic | Appetite Depressants | HIV Infections

Data type

boolean

Alias
UMLS CUI [1,1]
C0152171
UMLS CUI [1,2]
C0175668
UMLS CUI [1,3]
C0011644
UMLS CUI [2,1]
C2973725
UMLS CUI [2,2]
C0175668
UMLS CUI [2,3]
C0011644
UMLS CUI [3]
C0024141
UMLS CUI [4]
C0003620
UMLS CUI [5]
C0019693
right heart catheterization, completed prior to screening visit must meet pre-specified hemodynamic criteria
Description

Catheterization of right heart Complete | Criteria hemodynamic Pre-specified Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0189896
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C0243161
UMLS CUI [2,2]
C0019010
UMLS CUI [2,3]
C2826245
UMLS CUI [2,4]
C1550543
female subjects of childbearing potential must have a negative serum pregnancy test and must agree to use a reliable double barrier method of contraception until study completion and for at least four weeks following their final study visit
Description

Childbearing Potential Serum pregnancy test negative | Childbearing Potential Barrier Contraception double

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0004764
UMLS CUI [2,3]
C0205173
male subjects must be informed of the potential risks of testicular tubular atrophy and infertility associated with taking this study drug and queried regarding his understanding of the potential risks as described in the informed consent form
Description

Gender | Informed Consent | Atrophic seminiferous tubules Risk Associated with Investigational New Drug | Male infertility Risk Associated with Investigational New Drug

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0021430
UMLS CUI [3,1]
C1968705
UMLS CUI [3,2]
C0035647
UMLS CUI [3,3]
C0332281
UMLS CUI [3,4]
C0013230
UMLS CUI [4,1]
C0021364
UMLS CUI [4,2]
C0035647
UMLS CUI [4,3]
C0332281
UMLS CUI [4,4]
C0013230
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pah due to or associated with congenital heart disease, coronary artery disease, left heart disease, interstitial lung disease, chronic obstructive pulmonary disease, veno-occlusive disease, chronic thrombotic and/or embolic disease, or sleep apnea
Description

Pulmonary arterial hypertension Associated with Congenital heart disease | Pulmonary arterial hypertension Associated with Coronary Artery Disease | Pulmonary arterial hypertension Associated with Heart Disease Left sided | Pulmonary arterial hypertension Associated with Lung Diseases, Interstitial | Pulmonary arterial hypertension Associated with Chronic Obstructive Airway Disease | Pulmonary arterial hypertension Associated with Venoocclusive disease | Pulmonary arterial hypertension Associated with Thrombosis chronic | Pulmonary arterial hypertension Associated with Embolism chronic | Pulmonary arterial hypertension Associated with Sleep Apnea

Data type

boolean

Alias
UMLS CUI [1,1]
C2973725
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0152021
UMLS CUI [2,1]
C2973725
UMLS CUI [2,2]
C0332281
UMLS CUI [2,3]
C1956346
UMLS CUI [3,1]
C2973725
UMLS CUI [3,2]
C0332281
UMLS CUI [3,3]
C0018799
UMLS CUI [3,4]
C0443246
UMLS CUI [4,1]
C2973725
UMLS CUI [4,2]
C0332281
UMLS CUI [4,3]
C0206062
UMLS CUI [5,1]
C2973725
UMLS CUI [5,2]
C0332281
UMLS CUI [5,3]
C0024117
UMLS CUI [6,1]
C2973725
UMLS CUI [6,2]
C0332281
UMLS CUI [6,3]
C0948441
UMLS CUI [7,1]
C2973725
UMLS CUI [7,2]
C0332281
UMLS CUI [7,3]
C0040053
UMLS CUI [7,4]
C0205191
UMLS CUI [8,1]
C2973725
UMLS CUI [8,2]
C0332281
UMLS CUI [8,3]
C0013922
UMLS CUI [8,4]
C0205191
UMLS CUI [9,1]
C2973725
UMLS CUI [9,2]
C0332281
UMLS CUI [9,3]
C0037315
portopulmonary hypertension
Description

Portopulmonary hypertension

Data type

boolean

Alias
UMLS CUI [1]
C1868851
bosentan within four weeks prior to screening
Description

bosentan

Data type

boolean

Alias
UMLS CUI [1]
C0252643
phosphodiesterase type v inhibitor or chronic prostanoid therapy within four weeks prior to screening
Description

Phosphodiesterase 5 inhibitor | Prostaglandins chronic

Data type

boolean

Alias
UMLS CUI [1]
C1318700
UMLS CUI [2,1]
C0033554
UMLS CUI [2,2]
C0205191
iv inotrope use within two weeks prior to screening
Description

Cardiotonic Agents Intravenous

Data type

boolean

Alias
UMLS CUI [1,1]
C0007209
UMLS CUI [1,2]
C1522726
alt or ast lab value that is greater than 1.5 times the upper limit of normal
Description

Alanine aminotransferase increased | Aspartate aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0151905
UMLS CUI [2]
C0151904
pulmonary function tests not meeting pre-specified criteria
Description

Pulmonary function tests | Criteria Pre-specified Fulfill

Data type

boolean

Alias
UMLS CUI [1]
C0024119
UMLS CUI [2,1]
C0243161
UMLS CUI [2,2]
C2826245
UMLS CUI [2,3]
C1550543
contraindication to treatment with an era
Description

Medical contraindication Endothelin receptor antagonist

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1134681
history of malignancies other than basal cell carcinoma of the skin or in situ carcinoma of the cervix within the past five years
Description

Malignant Neoplasms | Basal cell carcinoma | Carcinoma in situ of uterine cervix

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0007117
UMLS CUI [3]
C0851140
females who are pregnant or breastfeeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147

Similar models

Eligibility Pulmonary Arterial Hypertension NCT00423202

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
18 years of age and older
boolean
C0001779 (UMLS CUI [1])
Idiopathic pulmonary hypertension Secondary to Scleroderma | Pulmonary arterial hypertension Secondary to Scleroderma | Lupus Erythematosus, Systemic | Appetite Depressants | HIV Infections
Item
current diagnosis of either pph or pah secondary to the scleroderma spectrum of disease, systemic lupus erythematosus, anorexigen use, or hiv infection at the screening visit
boolean
C0152171 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
C0011644 (UMLS CUI [1,3])
C2973725 (UMLS CUI [2,1])
C0175668 (UMLS CUI [2,2])
C0011644 (UMLS CUI [2,3])
C0024141 (UMLS CUI [3])
C0003620 (UMLS CUI [4])
C0019693 (UMLS CUI [5])
Catheterization of right heart Complete | Criteria hemodynamic Pre-specified Fulfill
Item
right heart catheterization, completed prior to screening visit must meet pre-specified hemodynamic criteria
boolean
C0189896 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0243161 (UMLS CUI [2,1])
C0019010 (UMLS CUI [2,2])
C2826245 (UMLS CUI [2,3])
C1550543 (UMLS CUI [2,4])
Childbearing Potential Serum pregnancy test negative | Childbearing Potential Barrier Contraception double
Item
female subjects of childbearing potential must have a negative serum pregnancy test and must agree to use a reliable double barrier method of contraception until study completion and for at least four weeks following their final study visit
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0004764 (UMLS CUI [2,2])
C0205173 (UMLS CUI [2,3])
Gender | Informed Consent | Atrophic seminiferous tubules Risk Associated with Investigational New Drug | Male infertility Risk Associated with Investigational New Drug
Item
male subjects must be informed of the potential risks of testicular tubular atrophy and infertility associated with taking this study drug and queried regarding his understanding of the potential risks as described in the informed consent form
boolean
C0079399 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
C1968705 (UMLS CUI [3,1])
C0035647 (UMLS CUI [3,2])
C0332281 (UMLS CUI [3,3])
C0013230 (UMLS CUI [3,4])
C0021364 (UMLS CUI [4,1])
C0035647 (UMLS CUI [4,2])
C0332281 (UMLS CUI [4,3])
C0013230 (UMLS CUI [4,4])
Item Group
C0680251 (UMLS CUI)
Pulmonary arterial hypertension Associated with Congenital heart disease | Pulmonary arterial hypertension Associated with Coronary Artery Disease | Pulmonary arterial hypertension Associated with Heart Disease Left sided | Pulmonary arterial hypertension Associated with Lung Diseases, Interstitial | Pulmonary arterial hypertension Associated with Chronic Obstructive Airway Disease | Pulmonary arterial hypertension Associated with Venoocclusive disease | Pulmonary arterial hypertension Associated with Thrombosis chronic | Pulmonary arterial hypertension Associated with Embolism chronic | Pulmonary arterial hypertension Associated with Sleep Apnea
Item
pah due to or associated with congenital heart disease, coronary artery disease, left heart disease, interstitial lung disease, chronic obstructive pulmonary disease, veno-occlusive disease, chronic thrombotic and/or embolic disease, or sleep apnea
boolean
C2973725 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0152021 (UMLS CUI [1,3])
C2973725 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C1956346 (UMLS CUI [2,3])
C2973725 (UMLS CUI [3,1])
C0332281 (UMLS CUI [3,2])
C0018799 (UMLS CUI [3,3])
C0443246 (UMLS CUI [3,4])
C2973725 (UMLS CUI [4,1])
C0332281 (UMLS CUI [4,2])
C0206062 (UMLS CUI [4,3])
C2973725 (UMLS CUI [5,1])
C0332281 (UMLS CUI [5,2])
C0024117 (UMLS CUI [5,3])
C2973725 (UMLS CUI [6,1])
C0332281 (UMLS CUI [6,2])
C0948441 (UMLS CUI [6,3])
C2973725 (UMLS CUI [7,1])
C0332281 (UMLS CUI [7,2])
C0040053 (UMLS CUI [7,3])
C0205191 (UMLS CUI [7,4])
C2973725 (UMLS CUI [8,1])
C0332281 (UMLS CUI [8,2])
C0013922 (UMLS CUI [8,3])
C0205191 (UMLS CUI [8,4])
C2973725 (UMLS CUI [9,1])
C0332281 (UMLS CUI [9,2])
C0037315 (UMLS CUI [9,3])
Portopulmonary hypertension
Item
portopulmonary hypertension
boolean
C1868851 (UMLS CUI [1])
bosentan
Item
bosentan within four weeks prior to screening
boolean
C0252643 (UMLS CUI [1])
Phosphodiesterase 5 inhibitor | Prostaglandins chronic
Item
phosphodiesterase type v inhibitor or chronic prostanoid therapy within four weeks prior to screening
boolean
C1318700 (UMLS CUI [1])
C0033554 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
Cardiotonic Agents Intravenous
Item
iv inotrope use within two weeks prior to screening
boolean
C0007209 (UMLS CUI [1,1])
C1522726 (UMLS CUI [1,2])
Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
alt or ast lab value that is greater than 1.5 times the upper limit of normal
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
Pulmonary function tests | Criteria Pre-specified Fulfill
Item
pulmonary function tests not meeting pre-specified criteria
boolean
C0024119 (UMLS CUI [1])
C0243161 (UMLS CUI [2,1])
C2826245 (UMLS CUI [2,2])
C1550543 (UMLS CUI [2,3])
Medical contraindication Endothelin receptor antagonist
Item
contraindication to treatment with an era
boolean
C1301624 (UMLS CUI [1,1])
C1134681 (UMLS CUI [1,2])
Malignant Neoplasms | Basal cell carcinoma | Carcinoma in situ of uterine cervix
Item
history of malignancies other than basal cell carcinoma of the skin or in situ carcinoma of the cervix within the past five years
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
C0851140 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
females who are pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])

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