ID

31715

Beskrivning

Safety Evaluation of Inhaled Treprostinil Administration Following Transition From Inhaled Ventavis in Pulmonary Arterial Hypertension (PAH) Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT00741819

Länk

https://clinicaltrials.gov/show/NCT00741819

Nyckelord

Versioner (1)
  1. 2018-09-22 2018-09-22 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

22 september 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Pulmonary Arterial Hypertension NCT00741819

Engelsk

Eligibility Pulmonary Arterial Hypertension NCT00741819

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
between 18 and 75 years of age
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
pah diagnosis defined by following who group i categories: idiopathic/familial, associated with unrepaired or repaired congenital systemic-to-pulmonary shunts (repaired >/= 5 years), associated with collagen vascular disease, associated with hiv, associated with appetite suppressant/toxin use
Beskrivning

Pulmonary arterial hypertension WHO classification | Idiopathic pulmonary arterial hypertension | Familial pulmonary arterial hypertension | Pulmonary arterial hypertension associated with congenital systemic-to-pulmonary shunt | Pulmonary arterial hypertension associated with congenital systemic-to-pulmonary shunt Repaired | Pulmonary arterial hypertension Associated with Collagen-vascular disease | Pulmonary arterial hypertension associated with HIV infection | Pulmonary arterial hypertension Associated with Appetite Depressants | Pulmonary arterial hypertension Associated with Use of Toxin

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2973725
UMLS CUI [1,2]
C4267671
UMLS CUI [2]
C3203102
UMLS CUI [3]
C1701939
UMLS CUI [4]
C3698160
UMLS CUI [5,1]
C3698160
UMLS CUI [5,2]
C0205340
UMLS CUI [6,1]
C2973725
UMLS CUI [6,2]
C0332281
UMLS CUI [6,3]
C0262428
UMLS CUI [7]
C3697673
UMLS CUI [8,1]
C2973725
UMLS CUI [8,2]
C0332281
UMLS CUI [8,3]
C0003620
UMLS CUI [9,1]
C2973725
UMLS CUI [9,2]
C0332281
UMLS CUI [9,3]
C1524063
UMLS CUI [9,4]
C0040549
baseline six-minute walk distance (6mwd) >/= 250 meters
Beskrivning

6-Minute Walk Test Meter Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0430515
UMLS CUI [1,2]
C0475209
UMLS CUI [1,3]
C1265611
currently receiving ventavis and be stable at current dose for 30 days prior to baseline
Beskrivning

Ventavis Dose Stable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1541936
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
if currently receiving other approved background therapy (i.e. endothelin receptor antagonist or phosphodiesterase-5-inhibitor or both) must be on stable dose for 30 days prior to baseline
Beskrivning

Background Therapy Dose Stable | Endothelin receptor antagonist Dose Stable | Phosphodiesterase 5 inhibitor Dose Stable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1706907
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0205360
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
previous testing (e.g. right heart catheterization, echocardiography) consistent with diagnosis of pah
Beskrivning

Testing Consistent with Pulmonary arterial hypertension | Catheterization of right heart | Echocardiography

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0039593
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C2973725
UMLS CUI [2]
C0189896
UMLS CUI [3]
C0013516
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
nursing or pregnant
Beskrivning

Breast Feeding | Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
has acute concomitant disease (e.g. portal hypertension, chronic thromboembolic disease, pulmonary veno-occlusive disease, etc) other than those accepted as part of the inclusion criteria or has had atrial septostomy
Beskrivning

Comorbidity Except Inclusion criteria | Hypertension, Portal | Thromboembolism chronic | Pulmonary Veno-Occlusive Disease | Atrial septostomy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0332300
UMLS CUI [1,3]
C1512693
UMLS CUI [2]
C0020541
UMLS CUI [3,1]
C0040038
UMLS CUI [3,2]
C0205191
UMLS CUI [4]
C0034091
UMLS CUI [5]
C0397233
history of uncontrolled sleep apnea, left-sided heart disease, or parenchymal lung disease
Beskrivning

Sleep Apnea Uncontrolled | Heart Disease Left sided Uncontrolled | Lung disease Parenchymal Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0037315
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0018799
UMLS CUI [2,2]
C0443246
UMLS CUI [2,3]
C0205318
UMLS CUI [3,1]
C0024115
UMLS CUI [3,2]
C4277702
UMLS CUI [3,3]
C0205318
use of investigational drug within 30 days of baseline
Beskrivning

Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
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Similar models

Eligibility Pulmonary Arterial Hypertension NCT00741819

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
between 18 and 75 years of age
boolean
C0001779 (UMLS CUI [1])
Pulmonary arterial hypertension WHO classification | Idiopathic pulmonary arterial hypertension | Familial pulmonary arterial hypertension | Pulmonary arterial hypertension associated with congenital systemic-to-pulmonary shunt | Pulmonary arterial hypertension associated with congenital systemic-to-pulmonary shunt Repaired | Pulmonary arterial hypertension Associated with Collagen-vascular disease | Pulmonary arterial hypertension associated with HIV infection | Pulmonary arterial hypertension Associated with Appetite Depressants | Pulmonary arterial hypertension Associated with Use of Toxin
Item
pah diagnosis defined by following who group i categories: idiopathic/familial, associated with unrepaired or repaired congenital systemic-to-pulmonary shunts (repaired >/= 5 years), associated with collagen vascular disease, associated with hiv, associated with appetite suppressant/toxin use
boolean
C2973725 (UMLS CUI [1,1])
C4267671 (UMLS CUI [1,2])
C3203102 (UMLS CUI [2])
C1701939 (UMLS CUI [3])
C3698160 (UMLS CUI [4])
C3698160 (UMLS CUI [5,1])
C0205340 (UMLS CUI [5,2])
C2973725 (UMLS CUI [6,1])
C0332281 (UMLS CUI [6,2])
C0262428 (UMLS CUI [6,3])
C3697673 (UMLS CUI [7])
C2973725 (UMLS CUI [8,1])
C0332281 (UMLS CUI [8,2])
C0003620 (UMLS CUI [8,3])
C2973725 (UMLS CUI [9,1])
C0332281 (UMLS CUI [9,2])
C1524063 (UMLS CUI [9,3])
C0040549 (UMLS CUI [9,4])
6-Minute Walk Test Meter Quantity
Item
baseline six-minute walk distance (6mwd) >/= 250 meters
boolean
C0430515 (UMLS CUI [1,1])
C0475209 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Ventavis Dose Stable
Item
currently receiving ventavis and be stable at current dose for 30 days prior to baseline
boolean
C1541936 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Background Therapy Dose Stable | Endothelin receptor antagonist Dose Stable | Phosphodiesterase 5 inhibitor Dose Stable
Item
if currently receiving other approved background therapy (i.e. endothelin receptor antagonist or phosphodiesterase-5-inhibitor or both) must be on stable dose for 30 days prior to baseline
boolean
C1706907 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0205360 (UMLS CUI [1,4])
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])
Testing Consistent with Pulmonary arterial hypertension | Catheterization of right heart | Echocardiography
Item
previous testing (e.g. right heart catheterization, echocardiography) consistent with diagnosis of pah
boolean
C0039593 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C2973725 (UMLS CUI [1,3])
C0189896 (UMLS CUI [2])
C0013516 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Breast Feeding | Pregnancy
Item
nursing or pregnant
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
Comorbidity Except Inclusion criteria | Hypertension, Portal | Thromboembolism chronic | Pulmonary Veno-Occlusive Disease | Atrial septostomy
Item
has acute concomitant disease (e.g. portal hypertension, chronic thromboembolic disease, pulmonary veno-occlusive disease, etc) other than those accepted as part of the inclusion criteria or has had atrial septostomy
boolean
C0009488 (UMLS CUI [1,1])
C0332300 (UMLS CUI [1,2])
C1512693 (UMLS CUI [1,3])
C0020541 (UMLS CUI [2])
C0040038 (UMLS CUI [3,1])
C0205191 (UMLS CUI [3,2])
C0034091 (UMLS CUI [4])
C0397233 (UMLS CUI [5])
Sleep Apnea Uncontrolled | Heart Disease Left sided Uncontrolled | Lung disease Parenchymal Uncontrolled
Item
history of uncontrolled sleep apnea, left-sided heart disease, or parenchymal lung disease
boolean
C0037315 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0018799 (UMLS CUI [2,1])
C0443246 (UMLS CUI [2,2])
C0205318 (UMLS CUI [2,3])
C0024115 (UMLS CUI [3,1])
C4277702 (UMLS CUI [3,2])
C0205318 (UMLS CUI [3,3])
Investigational New Drugs
Item
use of investigational drug within 30 days of baseline
boolean
C0013230 (UMLS CUI [1])
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