ID

32005

Beskrivning

Ambrisentan (Letairis) for Sarcoidosis Associated Pulmonary Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00851929

Länk

https://clinicaltrials.gov/show/NCT00851929

Nyckelord

Versioner (1)
  1. 2018-10-11 2018-10-11 -
Rättsinnehavare

See clinicaltrials.gov

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11 oktober 2018

DOI

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Creative Commons BY 4.0
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Eligibility Sarcoidosis NCT00851929

Engelsk

Eligibility Sarcoidosis NCT00851929

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
biopsy proven sarcoidosis
Beskrivning

Sarcoidosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0036202
mean pulmonary artery pressure > 25 mmhg at rest and greater than 30 mmhg with exercise by right heart catheterization within 1 year prior to entry into study
Beskrivning

Mean pulmonary arterial pressure At rest Catheterization of right heart | Mean pulmonary arterial pressure Exercise Catheterization of right heart

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3854605
UMLS CUI [1,2]
C0443144
UMLS CUI [1,3]
C0189896
UMLS CUI [2,1]
C3854605
UMLS CUI [2,2]
C0015259
UMLS CUI [2,3]
C0189896
pulmonary capillary wedge pressure ≤ 15 mmhg
Beskrivning

Pulmonary Capillary Wedge Pressure

Datatyp

boolean

Alias
UMLS CUI [1]
C0086879
pvr values >3.0 woods units
Beskrivning

Pulmonary Vascular Resistance Wood units

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0456261
UMLS CUI [1,2]
C0439525
forced vital capacity (fvc) >40%
Beskrivning

Forced Vital Capacity

Datatyp

boolean

Alias
UMLS CUI [1]
C3714541
who functional class ii or iii
Beskrivning

WHO classification Functional Status Class

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4267671
UMLS CUI [1,2]
C0598463
UMLS CUI [1,3]
C0456387
stable sarcoidosis treatment regimen for three months prior to entry into study
Beskrivning

Therapy Stable Sarcoidosis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C0036202
6 minute walk distance between 150-450 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
stable dose of antihypertensive medications
Beskrivning

Antihypertensive Agents Dose Stable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
on no other medication to treat pah (sildenafil, tadalafil, vardenafil, treprostinil, epoprostenol, iloprost, bosentan, sitaxsentan) within one month prior to enrollment and during duration of the study
Beskrivning

Absence Pharmaceutical Preparations Other Pulmonary arterial hypertension | sildenafil | tadalafil | vardenafil | Treprostinil | Epoprostenol | Iloprost | bosentan | sitaxsentan

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2973725
UMLS CUI [2]
C0529793
UMLS CUI [3]
C1176316
UMLS CUI [4]
C0971579
UMLS CUI [5]
C1145760
UMLS CUI [6]
C0033567
UMLS CUI [7]
C0079594
UMLS CUI [8]
C0252643
UMLS CUI [9]
C1704271
non-pregnant females
Beskrivning

Gender | Pregnancy Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0332197
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
exercise limitation related to a non-cardiopulmonary reason (e.g. arthritis)
Beskrivning

Exercise Limited | Etiology Except Cardiopulmonary disease | Etiology Arthritis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0015259
UMLS CUI [1,2]
C0439801
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C0034072
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0003864
severe systemic hypertension > 170/95
Beskrivning

Systemic hypertension Severe

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C0205082
patients with congestive heart failure (left ventricular dysfunction) or primary right ventricular dysfunction
Beskrivning

Congestive heart failure | Ventricular Dysfunction, Left | Right Ventricular Dysfunction Primary

Datatyp

boolean

Alias
UMLS CUI [1]
C0018802
UMLS CUI [2]
C0242698
UMLS CUI [3,1]
C0242707
UMLS CUI [3,2]
C0205225
anticipation by the investigator for escalation in sarcoidosis treatment during the course of the study
Beskrivning

Treatment escalation plan Sarcoidosis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4543664
UMLS CUI [1,2]
C0036202
pulmonary hypertension related to etiology other than sarcoidosis (i.e. hiv, scleroderma, etc.)
Beskrivning

Pulmonary Hypertension Relationship Etiology | Exception Sarcoidosis | HIV Infection | Scleroderma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020542
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0015127
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0036202
UMLS CUI [3]
C0019693
UMLS CUI [4]
C0011644
use within 1 month of an endothelin receptor antagonists (bosentan, sitaxsentan).
Beskrivning

Endothelin receptor antagonist | bosentan | sitaxsentan

Datatyp

boolean

Alias
UMLS CUI [1]
C1134681
UMLS CUI [2]
C0252643
UMLS CUI [3]
C1704271
who functional class iv status
Beskrivning

WHO classification Functional Status Class

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4267671
UMLS CUI [1,2]
C0598463
UMLS CUI [1,3]
C0456387
patients with significant left ventricular dysfunction
Beskrivning

Ventricular Dysfunction, Left

Datatyp

boolean

Alias
UMLS CUI [1]
C0242698
significant liver dysfunction not due to sarcoidosis.
Beskrivning

Liver Dysfunction | Relationship Absent Sarcoidosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2,1]
C0439849
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0036202
patients with severe other organ disease felt by investigators to impact on survival during the course of the study.
Beskrivning

Organic disease Severe Impact Survival

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0683324
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C4049986
UMLS CUI [1,4]
C0220921
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Similar models

Eligibility Sarcoidosis NCT00851929

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Sarcoidosis
Item
biopsy proven sarcoidosis
boolean
C0036202 (UMLS CUI [1])
Mean pulmonary arterial pressure At rest Catheterization of right heart | Mean pulmonary arterial pressure Exercise Catheterization of right heart
Item
mean pulmonary artery pressure > 25 mmhg at rest and greater than 30 mmhg with exercise by right heart catheterization within 1 year prior to entry into study
boolean
C3854605 (UMLS CUI [1,1])
C0443144 (UMLS CUI [1,2])
C0189896 (UMLS CUI [1,3])
C3854605 (UMLS CUI [2,1])
C0015259 (UMLS CUI [2,2])
C0189896 (UMLS CUI [2,3])
Pulmonary Capillary Wedge Pressure
Item
pulmonary capillary wedge pressure ≤ 15 mmhg
boolean
C0086879 (UMLS CUI [1])
Pulmonary Vascular Resistance Wood units
Item
pvr values >3.0 woods units
boolean
C0456261 (UMLS CUI [1,1])
C0439525 (UMLS CUI [1,2])
Forced Vital Capacity
Item
forced vital capacity (fvc) >40%
boolean
C3714541 (UMLS CUI [1])
WHO classification Functional Status Class
Item
who functional class ii or iii
boolean
C4267671 (UMLS CUI [1,1])
C0598463 (UMLS CUI [1,2])
C0456387 (UMLS CUI [1,3])
Therapy Stable Sarcoidosis
Item
stable sarcoidosis treatment regimen for three months prior to entry into study
boolean
C0087111 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0036202 (UMLS CUI [1,3])
6-Minute Walk Test Meter Quantity
Item
6 minute walk distance between 150-450 meters
boolean
C0430515 (UMLS CUI [1,1])
C0475209 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Antihypertensive Agents Dose Stable
Item
stable dose of antihypertensive medications
boolean
C0003364 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Absence Pharmaceutical Preparations Other Pulmonary arterial hypertension | sildenafil | tadalafil | vardenafil | Treprostinil | Epoprostenol | Iloprost | bosentan | sitaxsentan
Item
on no other medication to treat pah (sildenafil, tadalafil, vardenafil, treprostinil, epoprostenol, iloprost, bosentan, sitaxsentan) within one month prior to enrollment and during duration of the study
boolean
C0332197 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2973725 (UMLS CUI [1,4])
C0529793 (UMLS CUI [2])
C1176316 (UMLS CUI [3])
C0971579 (UMLS CUI [4])
C1145760 (UMLS CUI [5])
C0033567 (UMLS CUI [6])
C0079594 (UMLS CUI [7])
C0252643 (UMLS CUI [8])
C1704271 (UMLS CUI [9])
Gender | Pregnancy Absent
Item
non-pregnant females
boolean
C0079399 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Exercise Limited | Etiology Except Cardiopulmonary disease | Etiology Arthritis
Item
exercise limitation related to a non-cardiopulmonary reason (e.g. arthritis)
boolean
C0015259 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0015127 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0034072 (UMLS CUI [2,3])
C0015127 (UMLS CUI [3,1])
C0003864 (UMLS CUI [3,2])
Systemic hypertension Severe
Item
severe systemic hypertension > 170/95
boolean
C0020538 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Congestive heart failure | Ventricular Dysfunction, Left | Right Ventricular Dysfunction Primary
Item
patients with congestive heart failure (left ventricular dysfunction) or primary right ventricular dysfunction
boolean
C0018802 (UMLS CUI [1])
C0242698 (UMLS CUI [2])
C0242707 (UMLS CUI [3,1])
C0205225 (UMLS CUI [3,2])
Treatment escalation plan Sarcoidosis
Item
anticipation by the investigator for escalation in sarcoidosis treatment during the course of the study
boolean
C4543664 (UMLS CUI [1,1])
C0036202 (UMLS CUI [1,2])
Pulmonary Hypertension Relationship Etiology | Exception Sarcoidosis | HIV Infection | Scleroderma
Item
pulmonary hypertension related to etiology other than sarcoidosis (i.e. hiv, scleroderma, etc.)
boolean
C0020542 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0036202 (UMLS CUI [2,2])
C0019693 (UMLS CUI [3])
C0011644 (UMLS CUI [4])
Endothelin receptor antagonist | bosentan | sitaxsentan
Item
use within 1 month of an endothelin receptor antagonists (bosentan, sitaxsentan).
boolean
C1134681 (UMLS CUI [1])
C0252643 (UMLS CUI [2])
C1704271 (UMLS CUI [3])
WHO classification Functional Status Class
Item
who functional class iv status
boolean
C4267671 (UMLS CUI [1,1])
C0598463 (UMLS CUI [1,2])
C0456387 (UMLS CUI [1,3])
Ventricular Dysfunction, Left
Item
patients with significant left ventricular dysfunction
boolean
C0242698 (UMLS CUI [1])
Liver Dysfunction | Relationship Absent Sarcoidosis
Item
significant liver dysfunction not due to sarcoidosis.
boolean
C0086565 (UMLS CUI [1])
C0439849 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0036202 (UMLS CUI [2,3])
Organic disease Severe Impact Survival
Item
patients with severe other organ disease felt by investigators to impact on survival during the course of the study.
boolean
C0683324 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C4049986 (UMLS CUI [1,3])
C0220921 (UMLS CUI [1,4])
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