ID

40842

Description

A Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH); ODM derived from: https://clinicaltrials.gov/show/NCT01178073

Link

https://clinicaltrials.gov/show/NCT01178073

Keywords

Versions (1)
  1. 5/24/20 5/24/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 24, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension, Pulmonary NCT01178073

English

Eligibility Hypertension, Pulmonary NCT01178073

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects must have a diagnosis of pulmonary arterial hypertension (pah) due to the following:
Description

Pulmonary arterial hypertension

Data type

boolean

Alias
UMLS CUI [1]
C2973725
a. idiopathic or heritable pah b. pah associated with: i. connective tissue disease (e.g., limited scleroderma, diffuse scleroderma, mixed connective tissue disease, systemic lupus erythematosus, or overlap syndrome) ii. drugs or toxins iii. human immunodeficiency virus (hiv) infection iv. congenital heart defects repaired greater than 1 year prior to screening (i.e., atrial septal defects, ventricular septal defects, and patent ductus arteriosus) nb: subjects with portopulmonary hypertension and pulmonary veno-occlusive disease are not eligible for the study
Description

Idiopathic pulmonary arterial hypertension | Heritable pulmonary arterial hypertension | Connective Tissue Disease | Scleroderma, Limited | Diffuse Scleroderma | Mixed Connective Tissue Disease | Lupus Erythematosus, Systemic | Overlap syndrome | Drugs | Toxins | HIV Infection | Congenital Heart Defects Repaired | Atrial Septal Defects | Ventricular Septal Defects | Patent ductus arteriosus | Portopulmonary hypertension Ineligible | Pulmonary Veno-Occlusive Disease Ineligible

Data type

boolean

Alias
UMLS CUI [1]
C3203102
UMLS CUI [2]
C0340543
UMLS CUI [3]
C0009782
UMLS CUI [4]
C0748540
UMLS CUI [5]
C1258104
UMLS CUI [6]
C0026272
UMLS CUI [7]
C0024141
UMLS CUI [8]
C0410000
UMLS CUI [9]
C0242508
UMLS CUI [10]
C0040549
UMLS CUI [11]
C0019693
UMLS CUI [12,1]
C0018798
UMLS CUI [12,2]
C0205340
UMLS CUI [13]
C0018817
UMLS CUI [14]
C0018818
UMLS CUI [15]
C0013274
UMLS CUI [16,1]
C1868851
UMLS CUI [16,2]
C1512714
UMLS CUI [17,1]
C0034091
UMLS CUI [17,2]
C1512714
subject must have a current diagnosis of being in world health organisation (who) functional class ii or iii.
Description

Diagnosis WHO classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C4267671
subject must meet all of the following haemodynamic criteria by means of a right heart catheterization prior to screening:
Description

Criteria Hemodynamic Fulfill | Catheterization of right heart

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C0019010
UMLS CUI [1,3]
C1550543
UMLS CUI [2]
C0189896
i. mpap of ≥25 mmhg ii. pvr ≥ 300 dynes/sec/cm5 iii. pcwp or lvedp of ≤12 mmhg if pvr
Description

Mean pulmonary arterial pressure | Pulmonary Vascular Resistance | Pulmonary Capillary Wedge Pressure | Left ventricular end-diastolic pressure

Data type

boolean

Alias
UMLS CUI [1]
C3854605
UMLS CUI [2]
C0456261
UMLS CUI [3]
C0086879
UMLS CUI [4]
C0456190
≥300 to <500 dyne/sec/cm5 , or pcwp/lvedp ≤ 15 mmhg if pvr ≥500 dynes/sec/cm5
Description

Pulmonary Capillary Wedge Pressure | Left ventricular end-diastolic pressure | Pulmonary Vascular Resistance

Data type

boolean

Alias
UMLS CUI [1]
C0086879
UMLS CUI [2]
C0456190
UMLS CUI [3]
C0456261
subject must walk a distance of ≥125m and ≤500m at the screening visit
Description

Able to walk Distance m

Data type

boolean

Alias
UMLS CUI [1,1]
C2712089
UMLS CUI [1,2]
C0012751
UMLS CUI [1,3]
C0475209
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject received previous pah therapy (phosphodiesterase type 5 inhibitor (pde5i), endothelin receptor antagonist (era), chronic prostanoid*) within 4 weeks prior to the screening visit (*chronic prostanoid use is considered >7 days of treatment)
Description

Prior Therapy Pulmonary arterial hypertension | Phosphodiesterase 5 inhibitor | Endothelin receptor antagonist | Prostaglandins chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C2973725
UMLS CUI [2]
C1318700
UMLS CUI [3]
C1134681
UMLS CUI [4,1]
C0033554
UMLS CUI [4,2]
C0205191
subject received era treatment (e.g., bosentan or sitaxentan) or pde5i treatment (e.g. sildenafil) at any time and discontinued due to tolerance issues other than those associated with liver function abnormalities
Description

Endothelin receptor antagonist | bosentan | sitaxsentan | Phosphodiesterase 5 inhibitor | sildenafil

Data type

boolean

Alias
UMLS CUI [1]
C1134681
UMLS CUI [2]
C0252643
UMLS CUI [3]
C1704271
UMLS CUI [4]
C1318700
UMLS CUI [5]
C0529793
subjects who have previously discontinued ambrisentan or tadalafil in either another clinical study or commercial product (volibris/letairis or adcirca) for safety or tolerability reasons.
Description

Ambrisentan Discontinued | Tadalafil Discontinued | Letairis Discontinued | Adcirca Discontinued

Data type

boolean

Alias
UMLS CUI [1,1]
C1176329
UMLS CUI [1,2]
C1444662
UMLS CUI [2,1]
C1176316
UMLS CUI [2,2]
C1444662
UMLS CUI [3,1]
C1949323
UMLS CUI [3,2]
C1444662
UMLS CUI [4,1]
C2709986
UMLS CUI [4,2]
C1444662
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Similar models

Eligibility Hypertension, Pulmonary NCT01178073

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Pulmonary arterial hypertension
Item
subjects must have a diagnosis of pulmonary arterial hypertension (pah) due to the following:
boolean
C2973725 (UMLS CUI [1])
Idiopathic pulmonary arterial hypertension | Heritable pulmonary arterial hypertension | Connective Tissue Disease | Scleroderma, Limited | Diffuse Scleroderma | Mixed Connective Tissue Disease | Lupus Erythematosus, Systemic | Overlap syndrome | Drugs | Toxins | HIV Infection | Congenital Heart Defects Repaired | Atrial Septal Defects | Ventricular Septal Defects | Patent ductus arteriosus | Portopulmonary hypertension Ineligible | Pulmonary Veno-Occlusive Disease Ineligible
Item
a. idiopathic or heritable pah b. pah associated with: i. connective tissue disease (e.g., limited scleroderma, diffuse scleroderma, mixed connective tissue disease, systemic lupus erythematosus, or overlap syndrome) ii. drugs or toxins iii. human immunodeficiency virus (hiv) infection iv. congenital heart defects repaired greater than 1 year prior to screening (i.e., atrial septal defects, ventricular septal defects, and patent ductus arteriosus) nb: subjects with portopulmonary hypertension and pulmonary veno-occlusive disease are not eligible for the study
boolean
C3203102 (UMLS CUI [1])
C0340543 (UMLS CUI [2])
C0009782 (UMLS CUI [3])
C0748540 (UMLS CUI [4])
C1258104 (UMLS CUI [5])
C0026272 (UMLS CUI [6])
C0024141 (UMLS CUI [7])
C0410000 (UMLS CUI [8])
C0242508 (UMLS CUI [9])
C0040549 (UMLS CUI [10])
C0019693 (UMLS CUI [11])
C0018798 (UMLS CUI [12,1])
C0205340 (UMLS CUI [12,2])
C0018817 (UMLS CUI [13])
C0018818 (UMLS CUI [14])
C0013274 (UMLS CUI [15])
C1868851 (UMLS CUI [16,1])
C1512714 (UMLS CUI [16,2])
C0034091 (UMLS CUI [17,1])
C1512714 (UMLS CUI [17,2])
Diagnosis WHO classification
Item
subject must have a current diagnosis of being in world health organisation (who) functional class ii or iii.
boolean
C0011900 (UMLS CUI [1,1])
C4267671 (UMLS CUI [1,2])
Criteria Hemodynamic Fulfill | Catheterization of right heart
Item
subject must meet all of the following haemodynamic criteria by means of a right heart catheterization prior to screening:
boolean
C0243161 (UMLS CUI [1,1])
C0019010 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
C0189896 (UMLS CUI [2])
Mean pulmonary arterial pressure | Pulmonary Vascular Resistance | Pulmonary Capillary Wedge Pressure | Left ventricular end-diastolic pressure
Item
i. mpap of ≥25 mmhg ii. pvr ≥ 300 dynes/sec/cm5 iii. pcwp or lvedp of ≤12 mmhg if pvr
boolean
C3854605 (UMLS CUI [1])
C0456261 (UMLS CUI [2])
C0086879 (UMLS CUI [3])
C0456190 (UMLS CUI [4])
Pulmonary Capillary Wedge Pressure | Left ventricular end-diastolic pressure | Pulmonary Vascular Resistance
Item
≥300 to <500 dyne/sec/cm5 , or pcwp/lvedp ≤ 15 mmhg if pvr ≥500 dynes/sec/cm5
boolean
C0086879 (UMLS CUI [1])
C0456190 (UMLS CUI [2])
C0456261 (UMLS CUI [3])
Able to walk Distance m
Item
subject must walk a distance of ≥125m and ≤500m at the screening visit
boolean
C2712089 (UMLS CUI [1,1])
C0012751 (UMLS CUI [1,2])
C0475209 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Prior Therapy Pulmonary arterial hypertension | Phosphodiesterase 5 inhibitor | Endothelin receptor antagonist | Prostaglandins chronic
Item
subject received previous pah therapy (phosphodiesterase type 5 inhibitor (pde5i), endothelin receptor antagonist (era), chronic prostanoid*) within 4 weeks prior to the screening visit (*chronic prostanoid use is considered >7 days of treatment)
boolean
C1514463 (UMLS CUI [1,1])
C2973725 (UMLS CUI [1,2])
C1318700 (UMLS CUI [2])
C1134681 (UMLS CUI [3])
C0033554 (UMLS CUI [4,1])
C0205191 (UMLS CUI [4,2])
Endothelin receptor antagonist | bosentan | sitaxsentan | Phosphodiesterase 5 inhibitor | sildenafil
Item
subject received era treatment (e.g., bosentan or sitaxentan) or pde5i treatment (e.g. sildenafil) at any time and discontinued due to tolerance issues other than those associated with liver function abnormalities
boolean
C1134681 (UMLS CUI [1])
C0252643 (UMLS CUI [2])
C1704271 (UMLS CUI [3])
C1318700 (UMLS CUI [4])
C0529793 (UMLS CUI [5])
Ambrisentan Discontinued | Tadalafil Discontinued | Letairis Discontinued | Adcirca Discontinued
Item
subjects who have previously discontinued ambrisentan or tadalafil in either another clinical study or commercial product (volibris/letairis or adcirca) for safety or tolerability reasons.
boolean
C1176329 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C1176316 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C1949323 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
C2709986 (UMLS CUI [4,1])
C1444662 (UMLS CUI [4,2])
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