Informações:
Falhas:
ID
19121
Descrição
Phase 2 Extension Study of Ambrisentan in Pulmonary Arterial Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00424021
Link
https://clinicaltrials.gov/show/NCT00424021
Palavras-chave
Versões (1)
- 06/12/2016 06/12/2016 -
Transferido a
6 de dezembro de 2016
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Pulmonary Hypertension NCT00424021
Eligibility Pulmonary Hypertension NCT00424021
- StudyEvent: Eligibility
Similar models
Eligibility Pulmonary Hypertension NCT00424021
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
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])
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])
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])
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])
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])
C0205360 (UMLS CUI [1,2])
C2973725 (UMLS CUI [1,3])
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])
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])
C1522726 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
females who are pregnant or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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])
C1134681 (UMLS CUI [1,2])