ID

31735

Descrição

FREEDOM DR: Oral Treprostinil in Combination With an Endothelin Receptor Antagonist (ERA) and/or a Phosphodiesterase-5 (PDE-5) Inhibitor or as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (PAH); ODM derived from: https://clinicaltrials.gov/show/NCT00760916

Link

https://clinicaltrials.gov/show/NCT00760916

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 NCT00760916

Inglês

Eligibility Pulmonary Hypertension NCT00760916

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
between 18 and 70 years of age, inclusive
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
body weight at least 50 kilograms
Descrição

Body Weight

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0005910
pah that is either idiopathic/familial; associated with repaired congenital systemic-to-pulmonary shunts (repaired ≥ 5 years); associated with collagen vascular disease; associated with hiv.
Descrição

Idiopathic pulmonary arterial hypertension | Familial pulmonary arterial hypertension | Pulmonary arterial hypertension associated with congenital systemic-to-pulmonary shunt Repaired | Pulmonary arterial hypertension Associated with Collagen-vascular disease | Pulmonary arterial hypertension associated with HIV infection

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3203102
UMLS CUI [2]
C1701939
UMLS CUI [3,1]
C3698160
UMLS CUI [3,2]
C0205340
UMLS CUI [4,1]
C2973725
UMLS CUI [4,2]
C0332281
UMLS CUI [4,3]
C0262428
UMLS CUI [5]
C3697673
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 or not currently receiving approved pah therapy.
Descrição

Endothelin receptor antagonist Dose Stable | Phosphodiesterase 5 inhibitor Dose Stable | Therapeutic procedure Absent Pulmonary arterial hypertension

Tipo de dados

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
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C2973725
previous testing (e.g., right heart catheterization, echocardiography) consistent with the diagnosis of pah.
Descrição

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

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0039593
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C2973725
UMLS CUI [2]
C0189896
UMLS CUI [3]
C0013516
reliable and cooperative with protocol requirements.
Descrição

Protocol Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
nursing or pregnant.
Descrição

Breast Feeding | Pregnancy

Tipo de dados

boolean

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

Prostacyclins

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0205911
pah due to conditions other than noted in the above inclusion criteria.
Descrição

Pulmonary arterial hypertension Due to Other medical condition | Exception Inclusion criteria

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2973725
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C3843040
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1512693
history of uncontrolled sleep apnea, renal insufficiency, anemia, left sided heart disease, uncontrolled systemic hypertension, or parenchymal lung disease.
Descrição

Sleep Apnea Uncontrolled | Renal Insufficiency | Anemia | Heart Disease Left sided | Uncontrolled hypertension | Diffuse Parenchymal Lung Disease

Tipo de dados

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]
C1868885
UMLS CUI [6]
C0206062
use of an investigational drug within 30 days of baseline
Descrição

Investigational New Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013230
Voltar ao início da página

Similar models

Eligibility Pulmonary Hypertension NCT00760916

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
between 18 and 70 years of age, inclusive
boolean
C0001779 (UMLS CUI [1])
Body Weight
Item
body weight at least 50 kilograms
boolean
C0005910 (UMLS CUI [1])
Idiopathic pulmonary arterial hypertension | Familial pulmonary arterial hypertension | Pulmonary arterial hypertension associated with congenital systemic-to-pulmonary shunt Repaired | Pulmonary arterial hypertension Associated with Collagen-vascular disease | Pulmonary arterial hypertension associated with HIV infection
Item
pah that is either idiopathic/familial; associated with repaired congenital systemic-to-pulmonary shunts (repaired ≥ 5 years); associated with collagen vascular disease; associated with hiv.
boolean
C3203102 (UMLS CUI [1])
C1701939 (UMLS CUI [2])
C3698160 (UMLS CUI [3,1])
C0205340 (UMLS CUI [3,2])
C2973725 (UMLS CUI [4,1])
C0332281 (UMLS CUI [4,2])
C0262428 (UMLS CUI [4,3])
C3697673 (UMLS CUI [5])
Endothelin receptor antagonist Dose Stable | Phosphodiesterase 5 inhibitor Dose Stable | Therapeutic procedure Absent Pulmonary arterial hypertension
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 or not currently receiving approved pah therapy.
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])
C0087111 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C2973725 (UMLS CUI [3,3])
Testing Consistent with Pulmonary arterial hypertension | Catheterization of right heart | Echocardiography
Item
previous testing (e.g., right heart catheterization, echocardiography) consistent with the diagnosis of pah.
boolean
C0039593 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C2973725 (UMLS CUI [1,3])
C0189896 (UMLS CUI [2])
C0013516 (UMLS CUI [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])
Prostacyclins
Item
received a prostacyclin within the past 30 days.
boolean
C0205911 (UMLS CUI [1])
Pulmonary arterial hypertension Due to Other medical condition | Exception Inclusion criteria
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])
C1705847 (UMLS CUI [2,1])
C1512693 (UMLS CUI [2,2])
Sleep Apnea Uncontrolled | Renal Insufficiency | Anemia | Heart Disease Left sided | Uncontrolled hypertension | Diffuse Parenchymal Lung Disease
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])
C0206062 (UMLS CUI [6])
Investigational New Drugs
Item
use of an investigational drug within 30 days of baseline
boolean
C0013230 (UMLS CUI [1])
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