ID

31734

Beschrijving

The Efficacy and Safety of Vardenafil in the Treatment of Pulmonary Arterial Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00718952

Link

https://clinicaltrials.gov/show/NCT00718952

Trefwoorden

Versies (1)
  1. 24-09-18 24-09-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

24 september 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Pulmonary Hypertension NCT00718952

Engels

Eligibility Pulmonary Hypertension NCT00718952

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects aged 12-65.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
confirmed idiopathic pulmonary hypertension, connective tissue disease associated pulmonary hypertension, congenital heart disease(with eisenmenger syndrome) associated pulmonary hypertension.
Beschrijving

Idiopathic pulmonary hypertension | Pulmonary arterial hypertension associated with connective tissue disease | Pulmonary arterial hypertension associated with congenital heart disease | Eisenmenger Complex

Datatype

boolean

Alias
UMLS CUI [1]
C0152171
UMLS CUI [2]
C3697982
UMLS CUI [3]
C3697119
UMLS CUI [4]
C0013743
baseline 6-minutes walking distance 150m-550m.
Beschrijving

6-Minute Walk Test Meter Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0430515
UMLS CUI [1,2]
C0475209
UMLS CUI [1,3]
C1265611
who pulmonary hypertension function ii-iii with non-responder to calcium channel blockers.
Beschrijving

Pulmonary Hypertension WHO classification | Therapy non-responder Calcium Channel Blockers

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020542
UMLS CUI [1,2]
C4267671
UMLS CUI [2,1]
C0919875
UMLS CUI [2,2]
C0006684
documented written informed consent.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
the other types of pulmonary hypertension.
Beschrijving

Pulmonary Hypertension Type Other

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020542
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C0205394
subjects who refuse to subscribe written informed consents or can't cooperate with the trial well.
Beschrijving

Informed Consent Refused | Protocol Compliance Limited

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1705116
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0439801
subjects with serious acute or chronic disease involved liver, kidney, and brain or have to use potent cyp3a4-inhibitor or nitrate to treat the underlying diseases.
Beschrijving

Disease Serious Involvement Liver | Disease Serious Involvement Kidney | Disease Serious Involvement Brain | Chronic disease Serious Involvement Liver | Chronic disease Serious Involvement Kidney | Chronic disease Serious Involvement Brain | CYP3A4 Inhibitor Primary disorders | Nitrate Primary disorders

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C1314939
UMLS CUI [1,4]
C0023884
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C1314939
UMLS CUI [2,4]
C0022646
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0205404
UMLS CUI [3,3]
C1314939
UMLS CUI [3,4]
C0006104
UMLS CUI [4,1]
C0008679
UMLS CUI [4,2]
C0205404
UMLS CUI [4,3]
C1314939
UMLS CUI [4,4]
C0023884
UMLS CUI [5,1]
C0008679
UMLS CUI [5,2]
C0205404
UMLS CUI [5,3]
C1314939
UMLS CUI [5,4]
C0022646
UMLS CUI [6,1]
C0008679
UMLS CUI [6,2]
C0205404
UMLS CUI [6,3]
C1314939
UMLS CUI [6,4]
C0006104
UMLS CUI [7,1]
C3830624
UMLS CUI [7,2]
C0277554
UMLS CUI [8,1]
C0028125
UMLS CUI [8,2]
C0277554
subjects who are currently treated with sildenafil for pah or taking sildenafil or tadalafil.
Beschrijving

Sildenafil Pulmonary arterial hypertension | sildenafil | tadalafil

Datatype

boolean

Alias
UMLS CUI [1,1]
C0529793
UMLS CUI [1,2]
C2973725
UMLS CUI [2]
C0529793
UMLS CUI [3]
C1176316
other contraindications in package insert.
Beschrijving

Package Insert Containing Medical contraindications

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030174
UMLS CUI [1,2]
C0332256
UMLS CUI [1,3]
C1301624
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Similar models

Eligibility Pulmonary Hypertension NCT00718952

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
subjects aged 12-65.
boolean
C0001779 (UMLS CUI [1])
Idiopathic pulmonary hypertension | Pulmonary arterial hypertension associated with connective tissue disease | Pulmonary arterial hypertension associated with congenital heart disease | Eisenmenger Complex
Item
confirmed idiopathic pulmonary hypertension, connective tissue disease associated pulmonary hypertension, congenital heart disease(with eisenmenger syndrome) associated pulmonary hypertension.
boolean
C0152171 (UMLS CUI [1])
C3697982 (UMLS CUI [2])
C3697119 (UMLS CUI [3])
C0013743 (UMLS CUI [4])
6-Minute Walk Test Meter Quantity
Item
baseline 6-minutes walking distance 150m-550m.
boolean
C0430515 (UMLS CUI [1,1])
C0475209 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Pulmonary Hypertension WHO classification | Therapy non-responder Calcium Channel Blockers
Item
who pulmonary hypertension function ii-iii with non-responder to calcium channel blockers.
boolean
C0020542 (UMLS CUI [1,1])
C4267671 (UMLS CUI [1,2])
C0919875 (UMLS CUI [2,1])
C0006684 (UMLS CUI [2,2])
Informed Consent
Item
documented written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pulmonary Hypertension Type Other
Item
the other types of pulmonary hypertension.
boolean
C0020542 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Informed Consent Refused | Protocol Compliance Limited
Item
subjects who refuse to subscribe written informed consents or can't cooperate with the trial well.
boolean
C0021430 (UMLS CUI [1,1])
C1705116 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
Disease Serious Involvement Liver | Disease Serious Involvement Kidney | Disease Serious Involvement Brain | Chronic disease Serious Involvement Liver | Chronic disease Serious Involvement Kidney | Chronic disease Serious Involvement Brain | CYP3A4 Inhibitor Primary disorders | Nitrate Primary disorders
Item
subjects with serious acute or chronic disease involved liver, kidney, and brain or have to use potent cyp3a4-inhibitor or nitrate to treat the underlying diseases.
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])
C0023884 (UMLS CUI [1,4])
C0012634 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C1314939 (UMLS CUI [2,3])
C0022646 (UMLS CUI [2,4])
C0012634 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C1314939 (UMLS CUI [3,3])
C0006104 (UMLS CUI [3,4])
C0008679 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
C1314939 (UMLS CUI [4,3])
C0023884 (UMLS CUI [4,4])
C0008679 (UMLS CUI [5,1])
C0205404 (UMLS CUI [5,2])
C1314939 (UMLS CUI [5,3])
C0022646 (UMLS CUI [5,4])
C0008679 (UMLS CUI [6,1])
C0205404 (UMLS CUI [6,2])
C1314939 (UMLS CUI [6,3])
C0006104 (UMLS CUI [6,4])
C3830624 (UMLS CUI [7,1])
C0277554 (UMLS CUI [7,2])
C0028125 (UMLS CUI [8,1])
C0277554 (UMLS CUI [8,2])
Sildenafil Pulmonary arterial hypertension | sildenafil | tadalafil
Item
subjects who are currently treated with sildenafil for pah or taking sildenafil or tadalafil.
boolean
C0529793 (UMLS CUI [1,1])
C2973725 (UMLS CUI [1,2])
C0529793 (UMLS CUI [2])
C1176316 (UMLS CUI [3])
Package Insert Containing Medical contraindications
Item
other contraindications in package insert.
boolean
C0030174 (UMLS CUI [1,1])
C0332256 (UMLS CUI [1,2])
C1301624 (UMLS CUI [1,3])
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