ID

19121

Description

Phase 2 Extension Study of Ambrisentan in Pulmonary Arterial Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00424021

Link

https://clinicaltrials.gov/show/NCT00424021

Keywords

Versions (1)
  1. 12/6/16 12/6/16 -
Uploaded on

December 6, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Pulmonary Hypertension NCT00424021

English

Eligibility Pulmonary Hypertension NCT00424021

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
must have completed visit 14/week 24 of the nct00046319 study.
Description

Clinical Trial Previous Visit Completed

Data type

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C1512346
UMLS CUI [1,4]
C0205197
women of childbearing potential must have a negative urine pregnancy test at the screening/enrollment visit and agree to use a reliable double barrier method of contraception until study completion and for >=4 weeks following their final study visit.
Description

Childbearing Potential Urine pregnancy test negative | Childbearing Potential Barrier Contraception Double

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430057
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0004764
UMLS CUI [2,3]
C0205173
must have completed the down-titration period of nct00046319 prior to enrollment in amb-220-e and will meet the following additional criteria:
Description

Titration Decrease Completed | ambrisentan

Data type

boolean

Alias
UMLS CUI [1,1]
C0162621
UMLS CUI [1,2]
C0547047
UMLS CUI [1,3]
C0205197
UMLS CUI [2]
C1176329
subjects with a diagnosis of hiv must have stable disease status at the time of screening/enrollment.
Description

HIV Infection Stable status

Data type

boolean

Alias
UMLS CUI [1,1]
C0019693
UMLS CUI [1,2]
C0205360
must be stable on conventional therapy for pah for >=4 weeks prior to the screening visit.
Description

Conventional Treatment Stable Pulmonary arterial hypertension

Data type

boolean

Alias
UMLS CUI [1,1]
C2945704
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C2973725
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
chronic prostanoid therapy, or other investigational prostacyclin derivative within 4 weeks prior to the screening visit.
Description

Prostaglandin chronic | Epoprostenol Derivative Investigational

Data type

boolean

Alias
UMLS CUI [1,1]
C0033554
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0033567
UMLS CUI [2,2]
C1527240
UMLS CUI [2,3]
C1517586
intravenous inotrope use within 2 weeks prior to the screening visit.
Description

Cardiotonic Agent Intravenous

Data type

boolean

Alias
UMLS CUI [1,1]
C0007209
UMLS CUI [1,2]
C1522726
females who are pregnant or breastfeeding.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
contraindication to treatment with an endothelin receptor antagonist (era).
Description

Medical contraindication Endothelin receptor antagonist

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1134681
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Similar models

Eligibility Pulmonary Hypertension NCT00424021

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Clinical Trial Previous Visit Completed
Item
must have completed visit 14/week 24 of the nct00046319 study.
boolean
C0008976 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1512346 (UMLS CUI [1,3])
C0205197 (UMLS CUI [1,4])
Childbearing Potential Urine pregnancy test negative | Childbearing Potential Barrier Contraception Double
Item
women of childbearing potential must have a negative urine pregnancy test at the screening/enrollment visit and agree to use a reliable double barrier method of contraception until study completion and for >=4 weeks following their final study visit.
boolean
C3831118 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0004764 (UMLS CUI [2,2])
C0205173 (UMLS CUI [2,3])
Titration Decrease Completed | ambrisentan
Item
must have completed the down-titration period of nct00046319 prior to enrollment in amb-220-e and will meet the following additional criteria:
boolean
C0162621 (UMLS CUI [1,1])
C0547047 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C1176329 (UMLS CUI [2])
HIV Infection Stable status
Item
subjects with a diagnosis of hiv must have stable disease status at the time of screening/enrollment.
boolean
C0019693 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Conventional Treatment Stable Pulmonary arterial hypertension
Item
must be stable on conventional therapy for pah for >=4 weeks prior to the screening visit.
boolean
C2945704 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C2973725 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Prostaglandin chronic | Epoprostenol Derivative Investigational
Item
chronic prostanoid therapy, or other investigational prostacyclin derivative within 4 weeks prior to the screening visit.
boolean
C0033554 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0033567 (UMLS CUI [2,1])
C1527240 (UMLS CUI [2,2])
C1517586 (UMLS CUI [2,3])
Cardiotonic Agent Intravenous
Item
intravenous inotrope use within 2 weeks prior to the screening visit.
boolean
C0007209 (UMLS CUI [1,1])
C1522726 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
females who are pregnant or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Medical contraindication Endothelin receptor antagonist
Item
contraindication to treatment with an endothelin receptor antagonist (era).
boolean
C1301624 (UMLS CUI [1,1])
C1134681 (UMLS CUI [1,2])
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