ID

31735

Beskrivning

FREEDOM DR: Oral Treprostinil in Combination With an Endothelin Receptor Antagonist (ERA) and/or a Phosphodiesterase-5 (PDE-5) Inhibitor or as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (PAH); ODM derived from: https://clinicaltrials.gov/show/NCT00760916

Länk

https://clinicaltrials.gov/show/NCT00760916

Nyckelord

Versioner (1)
  1. 2018-09-24 2018-09-24 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

24 september 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Pulmonary Hypertension NCT00760916

Engelsk

Eligibility Pulmonary Hypertension NCT00760916

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
between 18 and 70 years of age, inclusive
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
body weight at least 50 kilograms
Beskrivning

Body Weight

Datatyp

boolean

Alias
UMLS CUI [1]
C0005910
pah that is either idiopathic/familial; associated with repaired congenital systemic-to-pulmonary shunts (repaired ≥ 5 years); associated with collagen vascular disease; associated with hiv.
Beskrivning

Idiopathic pulmonary arterial hypertension | Familial pulmonary arterial hypertension | 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

Datatyp

boolean

Alias
UMLS CUI [1]
C3203102
UMLS CUI [2]
C1701939
UMLS CUI [3,1]
C3698160
UMLS CUI [3,2]
C0205340
UMLS CUI [4,1]
C2973725
UMLS CUI [4,2]
C0332281
UMLS CUI [4,3]
C0262428
UMLS CUI [5]
C3697673
currently receiving an approved endothelin receptor antagonist and/or an approved phosphodiesterase-5 inhibitor for at least 90 days and on a stable dose for at least the last 30 days or not currently receiving approved pah therapy.
Beskrivning

Endothelin receptor antagonist Dose Stable | Phosphodiesterase 5 inhibitor Dose Stable | Therapeutic procedure Absent Pulmonary arterial hypertension

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1134681
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C1318700
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C2973725
previous testing (e.g., right heart catheterization, echocardiography) consistent with the 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
reliable and cooperative with protocol requirements.
Beskrivning

Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
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
received a prostacyclin within the past 30 days.
Beskrivning

Prostacyclins

Datatyp

boolean

Alias
UMLS CUI [1]
C0205911
pah due to conditions other than noted in the above inclusion criteria.
Beskrivning

Pulmonary arterial hypertension Due to Other medical condition | Exception Inclusion criteria

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2973725
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C3843040
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1512693
history of uncontrolled sleep apnea, renal insufficiency, anemia, left sided heart disease, uncontrolled systemic hypertension, or parenchymal lung disease.
Beskrivning

Sleep Apnea Uncontrolled | Renal Insufficiency | Anemia | Heart Disease Left sided | Uncontrolled hypertension | Diffuse Parenchymal Lung Disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0037315
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C1565489
UMLS CUI [3]
C0002871
UMLS CUI [4,1]
C0018799
UMLS CUI [4,2]
C0443246
UMLS CUI [5]
C1868885
UMLS CUI [6]
C0206062
use of an 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 Hypertension NCT00760916

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
between 18 and 70 years of age, inclusive
boolean
C0001779 (UMLS CUI [1])
Body Weight
Item
body weight at least 50 kilograms
boolean
C0005910 (UMLS CUI [1])
Idiopathic pulmonary arterial hypertension | Familial pulmonary arterial hypertension | 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
Item
pah that is either idiopathic/familial; associated with repaired congenital systemic-to-pulmonary shunts (repaired ≥ 5 years); associated with collagen vascular disease; associated with hiv.
boolean
C3203102 (UMLS CUI [1])
C1701939 (UMLS CUI [2])
C3698160 (UMLS CUI [3,1])
C0205340 (UMLS CUI [3,2])
C2973725 (UMLS CUI [4,1])
C0332281 (UMLS CUI [4,2])
C0262428 (UMLS CUI [4,3])
C3697673 (UMLS CUI [5])
Endothelin receptor antagonist Dose Stable | Phosphodiesterase 5 inhibitor Dose Stable | Therapeutic procedure Absent Pulmonary arterial hypertension
Item
currently receiving an approved endothelin receptor antagonist and/or an approved phosphodiesterase-5 inhibitor for at least 90 days and on a stable dose for at least the last 30 days or not currently receiving approved pah therapy.
boolean
C1134681 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C1318700 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0087111 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C2973725 (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 the 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])
Protocol Compliance
Item
reliable and cooperative with protocol requirements.
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Breast Feeding | Pregnancy
Item
nursing or pregnant.
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
Prostacyclins
Item
received a prostacyclin within the past 30 days.
boolean
C0205911 (UMLS CUI [1])
Pulmonary arterial hypertension Due to Other medical condition | Exception Inclusion criteria
Item
pah due to conditions other than noted in the above inclusion criteria.
boolean
C2973725 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C3843040 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C1512693 (UMLS CUI [2,2])
Sleep Apnea Uncontrolled | Renal Insufficiency | Anemia | Heart Disease Left sided | Uncontrolled hypertension | Diffuse Parenchymal Lung Disease
Item
history of uncontrolled sleep apnea, renal insufficiency, anemia, left sided heart disease, uncontrolled systemic hypertension, or parenchymal lung disease.
boolean
C0037315 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C1565489 (UMLS CUI [2])
C0002871 (UMLS CUI [3])
C0018799 (UMLS CUI [4,1])
C0443246 (UMLS CUI [4,2])
C1868885 (UMLS CUI [5])
C0206062 (UMLS CUI [6])
Investigational New Drugs
Item
use of an investigational drug within 30 days of baseline
boolean
C0013230 (UMLS CUI [1])
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