ID

31734

Descrição

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

Palavras-chave

Versões (1)
  1. 24/09/2018 24/09/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

24 de setembro de 2018

DOI

Para um pedido faça login.

Licença

Creative Commons BY 4.0
Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Voltar para os comentários do modelo
Comentários do grupo de itens para :

Comentários do item para :

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

Eligibility Pulmonary Hypertension NCT00718952

Inglês

Eligibility Pulmonary Hypertension NCT00718952

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects aged 12-65.
Descrição

Age

Tipo de dados

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.
Descrição

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

Tipo de dados

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.
Descrição

6-Minute Walk Test Meter Quantity

Tipo de dados

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.
Descrição

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

Tipo de dados

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.
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

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

Pulmonary Hypertension Type Other

Tipo de dados

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.
Descrição

Informed Consent Refused | Protocol Compliance Limited

Tipo de dados

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.
Descrição

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

Tipo de dados

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.
Descrição

Sildenafil Pulmonary arterial hypertension | sildenafil | tadalafil

Tipo de dados

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.
Descrição

Package Insert Containing Medical contraindications

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0030174
UMLS CUI [1,2]
C0332256
UMLS CUI [1,3]
C1301624
Voltar ao início da página

Similar models

Eligibility Pulmonary Hypertension NCT00718952

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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])
Voltar ao início da página 

Contacto

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

Ajuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial