ID

22872

Description

FREEDOM-C: Oral Treprostinil in Combination With an Endothelin Receptor Antagonist (ERA) and/or a Phosphodiesterase-5 (PDE-5) Inhibitor for the Treatment of Pulmonary Arterial Hypertension (PAH); ODM derived from: https://clinicaltrials.gov/show/NCT00325442

Link

https://clinicaltrials.gov/show/NCT00325442

Keywords

Versions (1)
  1. 6/13/17 6/13/17 -
Uploaded on

June 13, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Pulmonary Hypertension NCT00325442

English

Eligibility Pulmonary Hypertension NCT00325442

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
between 12 and 70 years of age, inclusive.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
body weight at least 45 kg (approximately 100 pounds).
Description

Body Weight

Data type

boolean

Alias
UMLS CUI [1]
C0005910
pah that is either idiopathic/heritable (including pah associated with appetite suppressant/toxin use); pah associated with repaired congenital systemic-to-pulmonary shunts (repaired ≥ 5 years); pah associated with collagen vascular disease; or pah associated with hiv.
Description

Idiopathic pulmonary arterial hypertension | Familial primary pulmonary hypertension | Pulmonary arterial hypertension Associated with Appetite Depressants | Pulmonary arterial hypertension Associated with Toxin | Pulmonary arterial hypertension associated with congenital systemic-to-pulmonary shunt | Pulmonary arterial hypertension Associated with Collagen Disease | Pulmonary arterial hypertension Associated with HIV Infection

Data type

boolean

Alias
UMLS CUI [1]
C3203102
UMLS CUI [2]
C0340543
UMLS CUI [3,1]
C2973725
UMLS CUI [3,2]
C0332281
UMLS CUI [3,3]
C0003620
UMLS CUI [4,1]
C2973725
UMLS CUI [4,2]
C0332281
UMLS CUI [4,3]
C0040549
UMLS CUI [5]
C3698160
UMLS CUI [6,1]
C2973725
UMLS CUI [6,2]
C0332281
UMLS CUI [6,3]
C0009326
UMLS CUI [7,1]
C2973725
UMLS CUI [7,2]
C0332281
UMLS CUI [7,3]
C0019693
baseline 6-minute walk distance between 150 and 450 meters, inclusive.
Description

6-minute walk test Distance

Data type

boolean

Alias
UMLS CUI [1,1]
C0430515
UMLS CUI [1,2]
C0012751
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.
Description

Endothelin receptor antagonist Dose Stable | Phosphodiesterase 5 inhibitor Dose Stable

Data type

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
previous testing (e.g., right heart catheterization, echocardiography) consistent with the diagnosis of pah.
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0189896
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C2973725
UMLS CUI [2,1]
C0013516
UMLS CUI [2,2]
C0332290
UMLS CUI [2,3]
C2973725
reliable and cooperative with protocol requirements.
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
nursing or pregnant.
Description

Breast Feeding | Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
received a prostacyclin within the past 30 days.
Description

Epoprostenol

Data type

boolean

Alias
UMLS CUI [1]
C0033567
pah due to conditions other than noted in the above inclusion criteria.
Description

Pulmonary arterial hypertension Due to Other medical condition

Data type

boolean

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

Sleep Apnea Uncontrolled | Renal Insufficiency | Anemia | Heart Disease Left sided | Uncontrolled hypertension Systemic | Parenchymal lung disorders

Data type

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 [5,1]
C1868885
UMLS CUI [5,2]
C0205373
UMLS CUI [6]
C0852114
use of an investigational drug within 30 days of baseline.
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
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Similar models

Eligibility Pulmonary Hypertension NCT00325442

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
between 12 and 70 years of age, inclusive.
boolean
C0001779 (UMLS CUI [1])
Body Weight
Item
body weight at least 45 kg (approximately 100 pounds).
boolean
C0005910 (UMLS CUI [1])
Idiopathic pulmonary arterial hypertension | Familial primary pulmonary hypertension | Pulmonary arterial hypertension Associated with Appetite Depressants | Pulmonary arterial hypertension Associated with Toxin | Pulmonary arterial hypertension associated with congenital systemic-to-pulmonary shunt | Pulmonary arterial hypertension Associated with Collagen Disease | Pulmonary arterial hypertension Associated with HIV Infection
Item
pah that is either idiopathic/heritable (including pah associated with appetite suppressant/toxin use); pah associated with repaired congenital systemic-to-pulmonary shunts (repaired ≥ 5 years); pah associated with collagen vascular disease; or pah associated with hiv.
boolean
C3203102 (UMLS CUI [1])
C0340543 (UMLS CUI [2])
C2973725 (UMLS CUI [3,1])
C0332281 (UMLS CUI [3,2])
C0003620 (UMLS CUI [3,3])
C2973725 (UMLS CUI [4,1])
C0332281 (UMLS CUI [4,2])
C0040549 (UMLS CUI [4,3])
C3698160 (UMLS CUI [5])
C2973725 (UMLS CUI [6,1])
C0332281 (UMLS CUI [6,2])
C0009326 (UMLS CUI [6,3])
C2973725 (UMLS CUI [7,1])
C0332281 (UMLS CUI [7,2])
C0019693 (UMLS CUI [7,3])
6-minute walk test Distance
Item
baseline 6-minute walk distance between 150 and 450 meters, inclusive.
boolean
C0430515 (UMLS CUI [1,1])
C0012751 (UMLS CUI [1,2])
Endothelin receptor antagonist Dose Stable | Phosphodiesterase 5 inhibitor Dose Stable
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.
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])
Catheterization of right heart Consistent with Pulmonary arterial hypertension | Echocardiography Consistent with Pulmonary arterial hypertension
Item
previous testing (e.g., right heart catheterization, echocardiography) consistent with the diagnosis of pah.
boolean
C0189896 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C2973725 (UMLS CUI [1,3])
C0013516 (UMLS CUI [2,1])
C0332290 (UMLS CUI [2,2])
C2973725 (UMLS CUI [2,3])
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])
Epoprostenol
Item
received a prostacyclin within the past 30 days.
boolean
C0033567 (UMLS CUI [1])
Pulmonary arterial hypertension Due to Other medical condition
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])
Sleep Apnea Uncontrolled | Renal Insufficiency | Anemia | Heart Disease Left sided | Uncontrolled hypertension Systemic | Parenchymal lung disorders
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 [5,1])
C0205373 (UMLS CUI [5,2])
C0852114 (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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