ID

43697

Descripción

Safety, Efficacy and Treatment Satisfaction in Patients With PAH Rapidly Switched From Epoprostenol to Remodulin; ODM derived from: https://clinicaltrials.gov/show/NCT00373360

Link

https://clinicaltrials.gov/show/NCT00373360

Palabras clave

Versiones (2)
  1. 14/6/17 14/6/17 -
  2. 20/9/21 20/9/21 -
Subido en

20 de septiembre de 2021

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Pulmonary Hypertension NCT00373360

Inglés

Eligibility Pulmonary Hypertension NCT00373360

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18 to 70 years
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
diagnosis of idiopathic or familial pulmonary arterial hypertension (pah)or pah associated with a collagen vascular disease or pah associated with congenital systemic-to-pulmonary shunt repaired greater than 5 years prior to study entry or pah associated with portal hypertension with mild or moderate hepatic dysfunction (grade of a or b on the child-pugh classification scale)or pah associated with drug or toxins or cteph
Descripción

Idiopathic pulmonary arterial hypertension | Familial pulmonary arterial hypertension | Pulmonary arterial hypertension Associated with Collagen Disease | Pulmonary arterial hypertension associated with congenital systemic-to-pulmonary shunt | Pulmonary arterial hypertension associated with portal hypertension | Mild Liver dysfunction Child-Pugh Classification | Moderate Liver Dysfunction Child-Pugh Classification | Pulmonary arterial hypertension Associated with Pharmaceutical Preparations | Pulmonary arterial hypertension Associated with Toxin | Pulmonary arterial hypertension Associated with CTEPH

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3203102
UMLS CUI [2]
C1701939
UMLS CUI [3,1]
C2973725
UMLS CUI [3,2]
C0332281
UMLS CUI [3,3]
C0009326
UMLS CUI [4]
C3698160
UMLS CUI [5]
C1868851
UMLS CUI [6,1]
C3279149
UMLS CUI [6,2]
C4050412
UMLS CUI [7,1]
C0086565
UMLS CUI [7,2]
C0205081
UMLS CUI [7,3]
C4050412
UMLS CUI [8,1]
C2973725
UMLS CUI [8,2]
C0332281
UMLS CUI [8,3]
C0013227
UMLS CUI [9,1]
C2973725
UMLS CUI [9,2]
C0332281
UMLS CUI [9,3]
C0040549
UMLS CUI [10,1]
C2973725
UMLS CUI [10,2]
C0332281
UMLS CUI [10,3]
C2363973
who class ii-iii
Descripción

WHO Pulmonary arterial hypertension Class Functional

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0043237
UMLS CUI [1,2]
C2973725
UMLS CUI [1,3]
C0456387
UMLS CUI [1,4]
C0205245
currently receiving intravenous epoprostenol therapy for at least three months and a stable dose for at least one month.
Descripción

Epoprostenol Intravenous Dose Stable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0033567
UMLS CUI [1,2]
C1522726
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0205360
have central intravenous catheter
Descripción

Central venous catheter

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1145640
optimally treated with conventional pulmonary hypertension therapy and clinically stable for at least one month.
Descripción

Therapeutic procedure Optimal Pulmonary Hypertension | Stable status Clinical

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2698651
UMLS CUI [1,3]
C0020542
UMLS CUI [2,1]
C0205360
UMLS CUI [2,2]
C0205210
mentally and physically capable of learning to administer remodulin using an intravenous infusion pump.
Descripción

Remodulin | Infusion pump for intravenous fluids Use of Ability

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1101501
UMLS CUI [2,1]
C2317150
UMLS CUI [2,2]
C1524063
UMLS CUI [2,3]
C0085732
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
nursing or pregnant woman
Descripción

Breast Feeding | Pregnancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
have any other type of pah due to conditions other than noted in the above inclusion criteria, including but not limited to pah related to thrombotic or embolic disease
Descripción

Pulmonary arterial hypertension Due to Other medical condition | Pulmonary arterial hypertension Relationship Thrombotic vascular disease | Pulmonary arterial hypertension Relationship Embolism

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2973725
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C3843040
UMLS CUI [2,1]
C2973725
UMLS CUI [2,2]
C0439849
UMLS CUI [2,3]
C4049573
UMLS CUI [3,1]
C2973725
UMLS CUI [3,2]
C0439849
UMLS CUI [3,3]
C0013922
have any other disease that is associated with pulmonary hypertension (e.g. sickle cell anemia, schistosomiasis)
Descripción

Disease Associated with Pulmonary Hypertension | Anemia, Sickle Cell | Schistosomiasis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0020542
UMLS CUI [2]
C0002895
UMLS CUI [3]
C0036323
changes to chronic pah therapy (i.e., new therapy added within last 30 days[including but not limited to oxygen, a different category of vasodilator, a diuretic, digoxin, bosentan, sildenafil] or pah medication discontinued within 7 days of study entry.
Descripción

Therapeutic procedure Additional Pulmonary arterial hypertension | Oxygen Therapy | Vasodilator Agents Different | Diuretics | Digoxin | bosentan | sildenafil | Pulmonary arterial hypertension Pharmaceutical Preparations Discontinued

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1524062
UMLS CUI [1,3]
C2973725
UMLS CUI [2]
C0184633
UMLS CUI [3,1]
C0042402
UMLS CUI [3,2]
C1705242
UMLS CUI [4]
C0012798
UMLS CUI [5]
C0012265
UMLS CUI [6]
C0252643
UMLS CUI [7]
C0529793
UMLS CUI [8,1]
C2973725
UMLS CUI [8,2]
C0013227
UMLS CUI [8,3]
C1444662
received any prostacyclin or prostacyclin analog except epoprostenol in the past 3 months.
Descripción

Prostaglandins I | Prostaglandins I Analog | Epoprostenol

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0205911
UMLS CUI [2,1]
C0205911
UMLS CUI [2,2]
C0243071
UMLS CUI [3]
C0033567
central venous line infection within the past 30 days.
Descripción

Infection of central venous catheter

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1443396
previous documented evidence of significant parenchymal lung disease
Descripción

Lung disease Parenchyma

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0024115
UMLS CUI [1,2]
C0933845
evidence or history of left-sided heart disease
Descripción

Heart Disease Left sided

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0443246
musculoskeletal disorder or any other disease, which is thought to limit ambulation, or be connected to a machine that is not portable
Descripción

Musculoskeletal Disease Ambulation Limited | Disease Ambulation Limited | machine dependence

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0026857
UMLS CUI [1,2]
C0945826
UMLS CUI [1,3]
C0439801
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0945826
UMLS CUI [2,3]
C0439801
UMLS CUI [3]
C0260703
uncontrolled hypertension, chronic renal insufficiency, or active infection.
Descripción

Uncontrolled hypertension | Chronic Kidney Insufficiency | Communicable Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0403447
UMLS CUI [3]
C0009450
use of investigational drug within past 30 days.
Descripción

Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013230
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Similar models

Eligibility Pulmonary Hypertension NCT00373360

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 18 to 70 years
boolean
C0001779 (UMLS CUI [1])
Idiopathic pulmonary arterial hypertension | Familial pulmonary arterial hypertension | Pulmonary arterial hypertension Associated with Collagen Disease | Pulmonary arterial hypertension associated with congenital systemic-to-pulmonary shunt | Pulmonary arterial hypertension associated with portal hypertension | Mild Liver dysfunction Child-Pugh Classification | Moderate Liver Dysfunction Child-Pugh Classification | Pulmonary arterial hypertension Associated with Pharmaceutical Preparations | Pulmonary arterial hypertension Associated with Toxin | Pulmonary arterial hypertension Associated with CTEPH
Item
diagnosis of idiopathic or familial pulmonary arterial hypertension (pah)or pah associated with a collagen vascular disease or pah associated with congenital systemic-to-pulmonary shunt repaired greater than 5 years prior to study entry or pah associated with portal hypertension with mild or moderate hepatic dysfunction (grade of a or b on the child-pugh classification scale)or pah associated with drug or toxins or cteph
boolean
C3203102 (UMLS CUI [1])
C1701939 (UMLS CUI [2])
C2973725 (UMLS CUI [3,1])
C0332281 (UMLS CUI [3,2])
C0009326 (UMLS CUI [3,3])
C3698160 (UMLS CUI [4])
C1868851 (UMLS CUI [5])
C3279149 (UMLS CUI [6,1])
C4050412 (UMLS CUI [6,2])
C0086565 (UMLS CUI [7,1])
C0205081 (UMLS CUI [7,2])
C4050412 (UMLS CUI [7,3])
C2973725 (UMLS CUI [8,1])
C0332281 (UMLS CUI [8,2])
C0013227 (UMLS CUI [8,3])
C2973725 (UMLS CUI [9,1])
C0332281 (UMLS CUI [9,2])
C0040549 (UMLS CUI [9,3])
C2973725 (UMLS CUI [10,1])
C0332281 (UMLS CUI [10,2])
C2363973 (UMLS CUI [10,3])
WHO Pulmonary arterial hypertension Class Functional
Item
who class ii-iii
boolean
C0043237 (UMLS CUI [1,1])
C2973725 (UMLS CUI [1,2])
C0456387 (UMLS CUI [1,3])
C0205245 (UMLS CUI [1,4])
Epoprostenol Intravenous Dose Stable
Item
currently receiving intravenous epoprostenol therapy for at least three months and a stable dose for at least one month.
boolean
C0033567 (UMLS CUI [1,1])
C1522726 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0205360 (UMLS CUI [1,4])
Central venous catheter
Item
have central intravenous catheter
boolean
C1145640 (UMLS CUI [1])
Therapeutic procedure Optimal Pulmonary Hypertension | Stable status Clinical
Item
optimally treated with conventional pulmonary hypertension therapy and clinically stable for at least one month.
boolean
C0087111 (UMLS CUI [1,1])
C2698651 (UMLS CUI [1,2])
C0020542 (UMLS CUI [1,3])
C0205360 (UMLS CUI [2,1])
C0205210 (UMLS CUI [2,2])
Remodulin | Infusion pump for intravenous fluids Use of Ability
Item
mentally and physically capable of learning to administer remodulin using an intravenous infusion pump.
boolean
C1101501 (UMLS CUI [1])
C2317150 (UMLS CUI [2,1])
C1524063 (UMLS CUI [2,2])
C0085732 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Breast Feeding | Pregnancy
Item
nursing or pregnant woman
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
Pulmonary arterial hypertension Due to Other medical condition | Pulmonary arterial hypertension Relationship Thrombotic vascular disease | Pulmonary arterial hypertension Relationship Embolism
Item
have any other type of pah due to conditions other than noted in the above inclusion criteria, including but not limited to pah related to thrombotic or embolic disease
boolean
C2973725 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C3843040 (UMLS CUI [1,3])
C2973725 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C4049573 (UMLS CUI [2,3])
C2973725 (UMLS CUI [3,1])
C0439849 (UMLS CUI [3,2])
C0013922 (UMLS CUI [3,3])
Disease Associated with Pulmonary Hypertension | Anemia, Sickle Cell | Schistosomiasis
Item
have any other disease that is associated with pulmonary hypertension (e.g. sickle cell anemia, schistosomiasis)
boolean
C0012634 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0020542 (UMLS CUI [1,3])
C0002895 (UMLS CUI [2])
C0036323 (UMLS CUI [3])
Therapeutic procedure Additional Pulmonary arterial hypertension | Oxygen Therapy | Vasodilator Agents Different | Diuretics | Digoxin | bosentan | sildenafil | Pulmonary arterial hypertension Pharmaceutical Preparations Discontinued
Item
changes to chronic pah therapy (i.e., new therapy added within last 30 days[including but not limited to oxygen, a different category of vasodilator, a diuretic, digoxin, bosentan, sildenafil] or pah medication discontinued within 7 days of study entry.
boolean
C0087111 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C2973725 (UMLS CUI [1,3])
C0184633 (UMLS CUI [2])
C0042402 (UMLS CUI [3,1])
C1705242 (UMLS CUI [3,2])
C0012798 (UMLS CUI [4])
C0012265 (UMLS CUI [5])
C0252643 (UMLS CUI [6])
C0529793 (UMLS CUI [7])
C2973725 (UMLS CUI [8,1])
C0013227 (UMLS CUI [8,2])
C1444662 (UMLS CUI [8,3])
Prostaglandins I | Prostaglandins I Analog | Epoprostenol
Item
received any prostacyclin or prostacyclin analog except epoprostenol in the past 3 months.
boolean
C0205911 (UMLS CUI [1])
C0205911 (UMLS CUI [2,1])
C0243071 (UMLS CUI [2,2])
C0033567 (UMLS CUI [3])
Infection of central venous catheter
Item
central venous line infection within the past 30 days.
boolean
C1443396 (UMLS CUI [1])
Lung disease Parenchyma
Item
previous documented evidence of significant parenchymal lung disease
boolean
C0024115 (UMLS CUI [1,1])
C0933845 (UMLS CUI [1,2])
Heart Disease Left sided
Item
evidence or history of left-sided heart disease
boolean
C0018799 (UMLS CUI [1,1])
C0443246 (UMLS CUI [1,2])
Musculoskeletal Disease Ambulation Limited | Disease Ambulation Limited | machine dependence
Item
musculoskeletal disorder or any other disease, which is thought to limit ambulation, or be connected to a machine that is not portable
boolean
C0026857 (UMLS CUI [1,1])
C0945826 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0945826 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
C0260703 (UMLS CUI [3])
Uncontrolled hypertension | Chronic Kidney Insufficiency | Communicable Disease
Item
uncontrolled hypertension, chronic renal insufficiency, or active infection.
boolean
C1868885 (UMLS CUI [1])
C0403447 (UMLS CUI [2])
C0009450 (UMLS CUI [3])
Investigational New Drugs
Item
use of investigational drug within past 30 days.
boolean
C0013230 (UMLS CUI [1])
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