ID

40847

Beskrivning

First-line Bosentan and Sildenafil Combination Therapy for Pulmonary Arterial Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT01247116

Länk

https://clinicaltrials.gov/show/NCT01247116

Nyckelord

Versioner (1)
  1. 2020-05-24 2020-05-24 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

24 maj 2020

DOI

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Creative Commons BY 4.0
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Eligibility Hypertension, Pulmonary NCT01247116

Engelsk

Eligibility Hypertension, Pulmonary NCT01247116

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with symptomatic functional class iii pah in the following categories: idiopathic (ipah), familial (fpah), associated with connective tissue disease, associated with drugs or toxins
Beskrivning

Pulmonary arterial hypertension Symptomatic Functional Status Class | Idiopathic pulmonary arterial hypertension | Familial pulmonary arterial hypertension | Connective Tissue Disease | Drugs | Toxins

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2973725
UMLS CUI [1,2]
C0231220
UMLS CUI [1,3]
C0598463
UMLS CUI [1,4]
C0456387
UMLS CUI [2]
C3203102
UMLS CUI [3]
C1701939
UMLS CUI [4]
C0009782
UMLS CUI [5]
C0242508
UMLS CUI [6]
C0040549
pah diagnosed by right heart catheterization, defined as: mean pulmonary arterial pressure (mpap) ≥ 25 mmhg, pvr > 3 mmhg/l/min (wood units) or > 240 dyn sec cm-5, pulmonary capillary wedge pressure (pcwp) ≤ 15 mmhg
Beskrivning

Pulmonary arterial hypertension Catheterization of right heart | Mean pulmonary arterial pressure | Pulmonary Vascular Resistance Wood units | Pulmonary Vascular Resistance | Pulmonary Capillary Wedge Pressure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2973725
UMLS CUI [1,2]
C0189896
UMLS CUI [2]
C3854605
UMLS CUI [3,1]
C0456261
UMLS CUI [3,2]
C0439525
UMLS CUI [4]
C0456261
UMLS CUI [5]
C0086879
baseline 6 mwt distance > 150 and < 450 m
Beskrivning

6 Minute Walk Functional Test Distance m

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3900196
UMLS CUI [1,2]
C0012751
UMLS CUI [1,3]
C0475209
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with eras other than bosentan;
Beskrivning

Endothelin receptor antagonist | Exception Bosentan

Datatyp

boolean

Alias
UMLS CUI [1]
C1134681
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0252643
treatment with pde5 inhibitors other than sildenafil;
Beskrivning

Phosphodiesterase 5 inhibitor | Exception Sildenafil

Datatyp

boolean

Alias
UMLS CUI [1]
C1318700
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0529793
treatment with any prostanoid;
Beskrivning

Prostaglandins

Datatyp

boolean

Alias
UMLS CUI [1]
C0033554
pah associated with thyroid disorders, glycogen storage disease, gaucher disease, hereditary hemorrhagic telangiectasia, hemoglobinopathies, myeloproliferative disorders and splenectomy; valvular disease with valvular lesions to be excluded by echocardiogram within 2 years prior to randomization
Beskrivning

Pulmonary arterial hypertension Associated with Disease Specified | Thyroid Diseases | Glycogen Storage Disease | Gaucher Disease | Hereditary hemorrhagic telangiectasia | Hemoglobinopathies | Myeloproliferative disease | Splenectomy | Valvular disease | Valve Lesion Echocardiography

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2973725
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0012634
UMLS CUI [1,4]
C0205369
UMLS CUI [2]
C0040128
UMLS CUI [3]
C0017919
UMLS CUI [4]
C0017205
UMLS CUI [5]
C0039445
UMLS CUI [6]
C0019045
UMLS CUI [7]
C0027022
UMLS CUI [8]
C0037995
UMLS CUI [9]
C3258293
UMLS CUI [10,1]
C1186983
UMLS CUI [10,2]
C0221198
UMLS CUI [10,3]
C0013516
restrictive lung disease: total lung capacity (tlc) < 60% of normal predicted value;
Beskrivning

Restrictive lung disease | Percent Predicted Total Lung Capacity

Datatyp

boolean

Alias
UMLS CUI [1]
C0085581
UMLS CUI [2]
C3828589
obstructive lung disease: forced expiratory volume/forced vital capacity (fev1/fvc) < 50%
Beskrivning

Lung Diseases, Obstructive | FEV1/FVC percent

Datatyp

boolean

Alias
UMLS CUI [1]
C0600260
UMLS CUI [2]
C0730560
Tillbaka till toppen

Similar models

Eligibility Hypertension, Pulmonary NCT01247116

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Pulmonary arterial hypertension Symptomatic Functional Status Class | Idiopathic pulmonary arterial hypertension | Familial pulmonary arterial hypertension | Connective Tissue Disease | Drugs | Toxins
Item
patients with symptomatic functional class iii pah in the following categories: idiopathic (ipah), familial (fpah), associated with connective tissue disease, associated with drugs or toxins
boolean
C2973725 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0598463 (UMLS CUI [1,3])
C0456387 (UMLS CUI [1,4])
C3203102 (UMLS CUI [2])
C1701939 (UMLS CUI [3])
C0009782 (UMLS CUI [4])
C0242508 (UMLS CUI [5])
C0040549 (UMLS CUI [6])
Pulmonary arterial hypertension Catheterization of right heart | Mean pulmonary arterial pressure | Pulmonary Vascular Resistance Wood units | Pulmonary Vascular Resistance | Pulmonary Capillary Wedge Pressure
Item
pah diagnosed by right heart catheterization, defined as: mean pulmonary arterial pressure (mpap) ≥ 25 mmhg, pvr > 3 mmhg/l/min (wood units) or > 240 dyn sec cm-5, pulmonary capillary wedge pressure (pcwp) ≤ 15 mmhg
boolean
C2973725 (UMLS CUI [1,1])
C0189896 (UMLS CUI [1,2])
C3854605 (UMLS CUI [2])
C0456261 (UMLS CUI [3,1])
C0439525 (UMLS CUI [3,2])
C0456261 (UMLS CUI [4])
C0086879 (UMLS CUI [5])
6 Minute Walk Functional Test Distance m
Item
baseline 6 mwt distance > 150 and < 450 m
boolean
C3900196 (UMLS CUI [1,1])
C0012751 (UMLS CUI [1,2])
C0475209 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Endothelin receptor antagonist | Exception Bosentan
Item
treatment with eras other than bosentan;
boolean
C1134681 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0252643 (UMLS CUI [2,2])
Phosphodiesterase 5 inhibitor | Exception Sildenafil
Item
treatment with pde5 inhibitors other than sildenafil;
boolean
C1318700 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0529793 (UMLS CUI [2,2])
Prostaglandins
Item
treatment with any prostanoid;
boolean
C0033554 (UMLS CUI [1])
Pulmonary arterial hypertension Associated with Disease Specified | Thyroid Diseases | Glycogen Storage Disease | Gaucher Disease | Hereditary hemorrhagic telangiectasia | Hemoglobinopathies | Myeloproliferative disease | Splenectomy | Valvular disease | Valve Lesion Echocardiography
Item
pah associated with thyroid disorders, glycogen storage disease, gaucher disease, hereditary hemorrhagic telangiectasia, hemoglobinopathies, myeloproliferative disorders and splenectomy; valvular disease with valvular lesions to be excluded by echocardiogram within 2 years prior to randomization
boolean
C2973725 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C0205369 (UMLS CUI [1,4])
C0040128 (UMLS CUI [2])
C0017919 (UMLS CUI [3])
C0017205 (UMLS CUI [4])
C0039445 (UMLS CUI [5])
C0019045 (UMLS CUI [6])
C0027022 (UMLS CUI [7])
C0037995 (UMLS CUI [8])
C3258293 (UMLS CUI [9])
C1186983 (UMLS CUI [10,1])
C0221198 (UMLS CUI [10,2])
C0013516 (UMLS CUI [10,3])
Restrictive lung disease | Percent Predicted Total Lung Capacity
Item
restrictive lung disease: total lung capacity (tlc) < 60% of normal predicted value;
boolean
C0085581 (UMLS CUI [1])
C3828589 (UMLS CUI [2])
Lung Diseases, Obstructive | FEV1/FVC percent
Item
obstructive lung disease: forced expiratory volume/forced vital capacity (fev1/fvc) < 50%
boolean
C0600260 (UMLS CUI [1])
C0730560 (UMLS CUI [2])
Tillbaka till toppen 

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