ID

36975

Description

Comparative PK PD Study in PAH Patients (Fox vs. I-Neb); ODM derived from: https://clinicaltrials.gov/show/NCT02032836

Link

https://clinicaltrials.gov/show/NCT02032836

Keywords

Versions (2)
  1. 6/25/19 6/25/19 -
  2. 9/17/21 9/17/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 25, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Pulmonary Arterial Hypertension NCT02032836

English

Eligibility Pulmonary Arterial Hypertension NCT02032836

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female aged ≥ 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
current diagnosis of pulmonary hypertension (updated dana point classification 1).
Description

Pulmonary Hypertension Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0020542
UMLS CUI [1,2]
C0008902
current inhalative therapy with 5 µg iloprost using the i-neb nebulizer
Description

Inhalation Therapy Iloprost Dose | Use of Nebulizer

Data type

boolean

Alias
UMLS CUI [1,1]
C0021459
UMLS CUI [1,2]
C0079594
UMLS CUI [1,3]
C0178602
UMLS CUI [2,1]
C1524063
UMLS CUI [2,2]
C0027524
who functional class iii at the time of the patient's commencement of inhalative therapy with iloprost
Description

World Health Organization Class Functional

Data type

boolean

Alias
UMLS CUI [1,1]
C0043237
UMLS CUI [1,2]
C0456387
UMLS CUI [1,3]
C0205245
hemodynamic diagnosis of pulmonary arterial hypertension(pah) showing mean pulmonary arterial pressure (mpap) > 25 mmhg, pulmonary capillary wedge pressure (pcwp) or left ventricular end diastolic pressure (lvedp) < 15 mmhg and pulmonary vascular resistance (pvr) > 320 dyn•s•cm-5
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C2973725
UMLS CUI [2]
C3854605
UMLS CUI [3]
C0086879
UMLS CUI [4]
C0456190
UMLS CUI [5]
C0456261
if non-specific types of chronic treatment for pah are being administered: stable dosage of these for at least the 4 weeks up to screening
Description

Therapeutic procedure chronic Pulmonary arterial hypertension | Dose Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0205191
UMLS CUI [1,3]
C2973725
UMLS CUI [2,1]
C0178602
UMLS CUI [2,2]
C0205360
if pah-specific drug treatments (such as endothelin receptor antagonist (era) or phosphodiesterase-5 (pde5) inhibitors) are being administered: stable dosage of these for at least the 3 months up to screening.
Description

Pharmacotherapy Pulmonary arterial hypertension Specific | Endothelin receptor antagonist Dose Stable | Phosphodiesterase 5 inhibitor Dose Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C2973725
UMLS CUI [1,3]
C0205369
UMLS CUI [2,1]
C1134681
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [3,1]
C1318700
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0205360
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pah related to any other etiology, especially to pulmonary veno-occlusive disease (pvod)
Description

Pulmonary arterial hypertension Relationship Etiology | Etiology Pulmonary Veno-Occlusive Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C2973725
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0015127
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0034091
clinically relevant obstructive lung disease
Description

Lung Diseases, Obstructive

Data type

boolean

Alias
UMLS CUI [1]
C0600260
evidence of thromboembolic disease (probable pulmonary embolism) within 3 years before screening
Description

Thromboembolism | Pulmonary Embolism Probable

Data type

boolean

Alias
UMLS CUI [1]
C0040038
UMLS CUI [2,1]
C0034065
UMLS CUI [2,2]
C0033204
cerebrovascular events within 3 months before screening
Description

Event Cerebrovascular

Data type

boolean

Alias
UMLS CUI [1,1]
C0441471
UMLS CUI [1,2]
C1880018
atrial septostomy within the 6 months before screening
Description

Atrial septostomy

Data type

boolean

Alias
UMLS CUI [1]
C0397233
severe arrhythmia, or severe coronary heart disease or unstable angina, or myocardial infarction within 6 months before screening, or congenital or acquired valvular defects with clinically relevant myocardial function disorders unrelated to pah
Description

Cardiac Arrhythmia Severe | Coronary heart disease Severe | Angina, Unstable | Myocardial Infarction | Valvular defects Congenital | Valvular defects Acquired | Cardiomyopathy Independent of Pulmonary arterial hypertension

Data type

boolean

Alias
UMLS CUI [1,1]
C0003811
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0010068
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0002965
UMLS CUI [4]
C0027051
UMLS CUI [5,1]
C2748945
UMLS CUI [5,2]
C1744681
UMLS CUI [6,1]
C2748945
UMLS CUI [6,2]
C0439661
UMLS CUI [7,1]
C0878544
UMLS CUI [7,2]
C0332291
UMLS CUI [7,3]
C2973725
systolic blood pressure < 85 mm hg, or uncontrolled systemic hypertension (systolic bp > 160 mmhg or diastolic bp > 100 mmhg)
Description

Systolic Pressure | Hypertensive disease Uncontrolled | Diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2,1]
C0020538
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C0428883
hepatic impairment (child pugh b, c) or chronic renal insufficiency (creatinine > 2.5 mg/dl) and /or requirement of dialysis
Description

Hepatic impairment Child-Pugh Classification | Chronic Kidney Insufficiency | Creatinine measurement, serum | Requirement Dialysis

Data type

boolean

Alias
UMLS CUI [1,1]
C0948807
UMLS CUI [1,2]
C2347612
UMLS CUI [2]
C0403447
UMLS CUI [3]
C0201976
UMLS CUI [4,1]
C1514873
UMLS CUI [4,2]
C0011946
clinically relevant bleedings disorders or conditions with increased risk for hemorrhages (active ulcers, trauma etc.)
Description

Blood Coagulation Disorders | High risk of Hemorrhage | Ulcer | Trauma

Data type

boolean

Alias
UMLS CUI [1]
C0005779
UMLS CUI [2,1]
C0332167
UMLS CUI [2,2]
C0019080
UMLS CUI [3]
C0041582
UMLS CUI [4]
C3714660
addition or dose change of pah specific drug treatments such as era or pde5 inhibitors within 3 months before screening, or addition or dose change of non-specific treatments for pah such as calcium channel blockers, nitrates, digitalis, diuretics within 4 weeks before screening, or any kind of prostanoid other than those mentioned in inclusion criteria within less than 5 half-lives before treatment
Description

Pharmacotherapy Pulmonary arterial hypertension Specific | Pharmacotherapy Additional | Medication dose changed | Endothelin receptor antagonist | Phosphodiesterase 5 inhibitor | Therapeutic procedure Additional Pulmonary arterial hypertension | Calcium Channel Blockers | Nitrates | Digitalis preparation | Diuretics | Prostaglandins

Data type

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C2973725
UMLS CUI [1,3]
C0205369
UMLS CUI [2,1]
C0013216
UMLS CUI [2,2]
C1524062
UMLS CUI [3]
C1608430
UMLS CUI [4]
C1134681
UMLS CUI [5]
C1318700
UMLS CUI [6,1]
C0087111
UMLS CUI [6,2]
C1524062
UMLS CUI [6,3]
C2973725
UMLS CUI [7]
C0006684
UMLS CUI [8]
C0028125
UMLS CUI [9]
C0304520
UMLS CUI [10]
C0012798
UMLS CUI [11]
C0033554
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Similar models

Eligibility Pulmonary Arterial Hypertension NCT02032836

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female aged ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Pulmonary Hypertension Classification
Item
current diagnosis of pulmonary hypertension (updated dana point classification 1).
boolean
C0020542 (UMLS CUI [1,1])
C0008902 (UMLS CUI [1,2])
Inhalation Therapy Iloprost Dose | Use of Nebulizer
Item
current inhalative therapy with 5 µg iloprost using the i-neb nebulizer
boolean
C0021459 (UMLS CUI [1,1])
C0079594 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C1524063 (UMLS CUI [2,1])
C0027524 (UMLS CUI [2,2])
World Health Organization Class Functional
Item
who functional class iii at the time of the patient's commencement of inhalative therapy with iloprost
boolean
C0043237 (UMLS CUI [1,1])
C0456387 (UMLS CUI [1,2])
C0205245 (UMLS CUI [1,3])
Pulmonary arterial hypertension | Mean pulmonary arterial pressure | Pulmonary Capillary Wedge Pressure | Left ventricular end-diastolic pressure level | Pulmonary Vascular Resistance
Item
hemodynamic diagnosis of pulmonary arterial hypertension(pah) showing mean pulmonary arterial pressure (mpap) > 25 mmhg, pulmonary capillary wedge pressure (pcwp) or left ventricular end diastolic pressure (lvedp) < 15 mmhg and pulmonary vascular resistance (pvr) > 320 dyn•s•cm-5
boolean
C2973725 (UMLS CUI [1])
C3854605 (UMLS CUI [2])
C0086879 (UMLS CUI [3])
C0456190 (UMLS CUI [4])
C0456261 (UMLS CUI [5])
Therapeutic procedure chronic Pulmonary arterial hypertension | Dose Stable
Item
if non-specific types of chronic treatment for pah are being administered: stable dosage of these for at least the 4 weeks up to screening
boolean
C0087111 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C2973725 (UMLS CUI [1,3])
C0178602 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
Pharmacotherapy Pulmonary arterial hypertension Specific | Endothelin receptor antagonist Dose Stable | Phosphodiesterase 5 inhibitor Dose Stable
Item
if pah-specific drug treatments (such as endothelin receptor antagonist (era) or phosphodiesterase-5 (pde5) inhibitors) are being administered: stable dosage of these for at least the 3 months up to screening.
boolean
C0013216 (UMLS CUI [1,1])
C2973725 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
C1134681 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C1318700 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Pulmonary arterial hypertension Relationship Etiology | Etiology Pulmonary Veno-Occlusive Disease
Item
pah related to any other etiology, especially to pulmonary veno-occlusive disease (pvod)
boolean
C2973725 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C0015127 (UMLS CUI [2,1])
C0034091 (UMLS CUI [2,2])
Lung Diseases, Obstructive
Item
clinically relevant obstructive lung disease
boolean
C0600260 (UMLS CUI [1])
Thromboembolism | Pulmonary Embolism Probable
Item
evidence of thromboembolic disease (probable pulmonary embolism) within 3 years before screening
boolean
C0040038 (UMLS CUI [1])
C0034065 (UMLS CUI [2,1])
C0033204 (UMLS CUI [2,2])
Event Cerebrovascular
Item
cerebrovascular events within 3 months before screening
boolean
C0441471 (UMLS CUI [1,1])
C1880018 (UMLS CUI [1,2])
Atrial septostomy
Item
atrial septostomy within the 6 months before screening
boolean
C0397233 (UMLS CUI [1])
Cardiac Arrhythmia Severe | Coronary heart disease Severe | Angina, Unstable | Myocardial Infarction | Valvular defects Congenital | Valvular defects Acquired | Cardiomyopathy Independent of Pulmonary arterial hypertension
Item
severe arrhythmia, or severe coronary heart disease or unstable angina, or myocardial infarction within 6 months before screening, or congenital or acquired valvular defects with clinically relevant myocardial function disorders unrelated to pah
boolean
C0003811 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0010068 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0002965 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C2748945 (UMLS CUI [5,1])
C1744681 (UMLS CUI [5,2])
C2748945 (UMLS CUI [6,1])
C0439661 (UMLS CUI [6,2])
C0878544 (UMLS CUI [7,1])
C0332291 (UMLS CUI [7,2])
C2973725 (UMLS CUI [7,3])
Systolic Pressure | Hypertensive disease Uncontrolled | Diastolic blood pressure
Item
systolic blood pressure < 85 mm hg, or uncontrolled systemic hypertension (systolic bp > 160 mmhg or diastolic bp > 100 mmhg)
boolean
C0871470 (UMLS CUI [1])
C0020538 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0428883 (UMLS CUI [3])
Hepatic impairment Child-Pugh Classification | Chronic Kidney Insufficiency | Creatinine measurement, serum | Requirement Dialysis
Item
hepatic impairment (child pugh b, c) or chronic renal insufficiency (creatinine > 2.5 mg/dl) and /or requirement of dialysis
boolean
C0948807 (UMLS CUI [1,1])
C2347612 (UMLS CUI [1,2])
C0403447 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
C1514873 (UMLS CUI [4,1])
C0011946 (UMLS CUI [4,2])
Blood Coagulation Disorders | High risk of Hemorrhage | Ulcer | Trauma
Item
clinically relevant bleedings disorders or conditions with increased risk for hemorrhages (active ulcers, trauma etc.)
boolean
C0005779 (UMLS CUI [1])
C0332167 (UMLS CUI [2,1])
C0019080 (UMLS CUI [2,2])
C0041582 (UMLS CUI [3])
C3714660 (UMLS CUI [4])
Pharmacotherapy Pulmonary arterial hypertension Specific | Pharmacotherapy Additional | Medication dose changed | Endothelin receptor antagonist | Phosphodiesterase 5 inhibitor | Therapeutic procedure Additional Pulmonary arterial hypertension | Calcium Channel Blockers | Nitrates | Digitalis preparation | Diuretics | Prostaglandins
Item
addition or dose change of pah specific drug treatments such as era or pde5 inhibitors within 3 months before screening, or addition or dose change of non-specific treatments for pah such as calcium channel blockers, nitrates, digitalis, diuretics within 4 weeks before screening, or any kind of prostanoid other than those mentioned in inclusion criteria within less than 5 half-lives before treatment
boolean
C0013216 (UMLS CUI [1,1])
C2973725 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
C0013216 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
C1608430 (UMLS CUI [3])
C1134681 (UMLS CUI [4])
C1318700 (UMLS CUI [5])
C0087111 (UMLS CUI [6,1])
C1524062 (UMLS CUI [6,2])
C2973725 (UMLS CUI [6,3])
C0006684 (UMLS CUI [7])
C0028125 (UMLS CUI [8])
C0304520 (UMLS CUI [9])
C0012798 (UMLS CUI [10])
C0033554 (UMLS CUI [11])
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