ID

44641

Beskrivning

Iloprost Power 15 in Pulmonary Arterial Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00709956

Länk

https://clinicaltrials.gov/show/NCT00709956

Nyckelord

Versioner (2)
  1. 2018-09-22 2018-09-22 -
  2. 2021-09-27 2021-09-27 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

27 september 2021

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Pulmonary Arterial Hypertension NCT00709956

Engelsk

Eligibility Pulmonary Arterial Hypertension NCT00709956

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
signed informed consent prior to initiation of any study mandated procedure,
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
patients with symptomatic idiopathic, or familial pulmonary arterial hypertension or pulmonary hypertension associated with human immunodeficiency virus (hiv) or drugs/toxins in nyha functional class ii to iv.
Beskrivning

Idiopathic pulmonary arterial hypertension Symptomatic | Familial pulmonary arterial hypertension | Pulmonary arterial hypertension associated with HIV infection | (Associated) (drug-induced) (toxin-induced) pulmonary arterial hypertension | New York Heart Association Classification

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3203102
UMLS CUI [1,2]
C0231220
UMLS CUI [2]
C1701939
UMLS CUI [3]
C3697673
UMLS CUI [4]
C4509209
UMLS CUI [5]
C1275491
women of childbearing potential must have a negative urine pregnancy test and must use an adequate method of contraception during the study and for 28 days after discontinuation of the study drug.
Beskrivning

Childbearing Potential Urine pregnancy test negative | Childbearing Potential Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430057
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
pulmonary arterial hypertension related to any condition other than those specified in the inclusion criteria,
Beskrivning

Pulmonary arterial hypertension Relationship Condition Any | Exception Inclusion criteria

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2973725
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0348080
UMLS CUI [1,4]
C1552551
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1512693
pulmonary arterial hypertension associated with significant venous or capillary involvement (pulmonary capillary wedge pressure (pcwp) > 15 mmhg),
Beskrivning

Pulmonary arterial hypertension Associated with Involvement Venous | Pulmonary arterial hypertension Associated with Involvement Capillary | Pulmonary Capillary Wedge Pressure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2973725
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C1314939
UMLS CUI [1,4]
C0348013
UMLS CUI [2,1]
C2973725
UMLS CUI [2,2]
C0332281
UMLS CUI [2,3]
C1314939
UMLS CUI [2,4]
C0006901
UMLS CUI [3]
C0086879
known pulmonary veno-occlusive disease, or pulmonary capillary hemangiomatosis,
Beskrivning

Pulmonary Veno-Occlusive Disease | Pulmonary capillary hemangiomatosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0034091
UMLS CUI [2]
C0340548
moderate to severe obstructive lung disease: forced expiratory volume in 1 second/forced vital capacity (fev1/fvc) < 70% and fev1 < 65% of predicted value after bronchodilator administration,
Beskrivning

Obstructive Lung Disease Moderate | Obstructive Lung Disease Severe | FEV1/FVC percent post bronchodilator | Percent predicted FEV1 post bronchodilator

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0600260
UMLS CUI [1,2]
C0205081
UMLS CUI [2,1]
C0600260
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0730560
UMLS CUI [3,2]
C2599594
UMLS CUI [4,1]
C0730561
UMLS CUI [4,2]
C2599594
moderate to severe restrictive lung disease: total lung capacity (tlc) < 60% of predicted value,
Beskrivning

Restrictive lung disease Moderate | Restrictive lung disease Severe | Percent Predicted Total Lung Capacity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0085581
UMLS CUI [1,2]
C0205081
UMLS CUI [2,1]
C0085581
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C3828589
pregnant or breast-feeding women,
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
systemic hypertension (systolic blood pressure > 160 mmhg or diastolic blood pressure > 100 mmhg on repeated measurement),
Beskrivning

Systemic hypertension | Systolic Pressure Measurement Repeated | Diastolic blood pressure Measurement Repeated

Datatyp

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2,1]
C0871470
UMLS CUI [2,2]
C0242485
UMLS CUI [2,3]
C0205341
UMLS CUI [3,1]
C0428883
UMLS CUI [3,2]
C0242485
UMLS CUI [3,3]
C0205341
systolic blood pressure < 95 mmhg,
Beskrivning

Systolic Pressure

Datatyp

boolean

Alias
UMLS CUI [1]
C0871470
moderate to severe hepatic impairment, i.e., child-pugh class b or c,
Beskrivning

Hepatic impairment Moderate Child-Pugh Classification | Hepatic impairment Severe Child-Pugh Classification

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0948807
UMLS CUI [1,2]
C0205081
UMLS CUI [1,3]
C4050412
UMLS CUI [2,1]
C0948807
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C4050412
chronic renal insufficiency defined by serum creatinine > 2.5 mg/dl (221 μmol/l) or ongoing dialysis,
Beskrivning

Chronic Kidney Insufficiency | Creatinine measurement, serum | Dialysis Continuous

Datatyp

boolean

Alias
UMLS CUI [1]
C0403447
UMLS CUI [2]
C0201976
UMLS CUI [3,1]
C0011946
UMLS CUI [3,2]
C0549178
clinically relevant bleeding disorder or active bleeding,
Beskrivning

Blood Coagulation Disorder | Hemorrhage

Datatyp

boolean

Alias
UMLS CUI [1]
C0005779
UMLS CUI [2]
C0019080
for those patients on monotherapy, any contraindication to bosentan, ambrisentan, or sildenafil, according to product label,
Beskrivning

Medical contraindication Bosentan | Medical contraindication Ambrisentan | Medical contraindication Sildenafil

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0252643
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C1176329
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0529793
known hypersensitivity to iloprost or any of its excipients.
Beskrivning

Hypersensitivity Iloprost | Hypersensitivity Iloprost Excipient

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0079594
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0079594
UMLS CUI [2,3]
C0015237
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Similar models

Eligibility Pulmonary Arterial Hypertension NCT00709956

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
signed informed consent prior to initiation of any study mandated procedure,
boolean
C0021430 (UMLS CUI [1])
Idiopathic pulmonary arterial hypertension Symptomatic | Familial pulmonary arterial hypertension | Pulmonary arterial hypertension associated with HIV infection | (Associated) (drug-induced) (toxin-induced) pulmonary arterial hypertension | New York Heart Association Classification
Item
patients with symptomatic idiopathic, or familial pulmonary arterial hypertension or pulmonary hypertension associated with human immunodeficiency virus (hiv) or drugs/toxins in nyha functional class ii to iv.
boolean
C3203102 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C1701939 (UMLS CUI [2])
C3697673 (UMLS CUI [3])
C4509209 (UMLS CUI [4])
C1275491 (UMLS CUI [5])
Childbearing Potential Urine pregnancy test negative | Childbearing Potential Contraceptive methods
Item
women of childbearing potential must have a negative urine pregnancy test and must use an adequate method of contraception during the study and for 28 days after discontinuation of the study drug.
boolean
C3831118 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Pulmonary arterial hypertension Relationship Condition Any | Exception Inclusion criteria
Item
pulmonary arterial hypertension related to any condition other than those specified in the inclusion criteria,
boolean
C2973725 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0348080 (UMLS CUI [1,3])
C1552551 (UMLS CUI [1,4])
C1705847 (UMLS CUI [2,1])
C1512693 (UMLS CUI [2,2])
Pulmonary arterial hypertension Associated with Involvement Venous | Pulmonary arterial hypertension Associated with Involvement Capillary | Pulmonary Capillary Wedge Pressure
Item
pulmonary arterial hypertension associated with significant venous or capillary involvement (pulmonary capillary wedge pressure (pcwp) > 15 mmhg),
boolean
C2973725 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])
C0348013 (UMLS CUI [1,4])
C2973725 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C1314939 (UMLS CUI [2,3])
C0006901 (UMLS CUI [2,4])
C0086879 (UMLS CUI [3])
Pulmonary Veno-Occlusive Disease | Pulmonary capillary hemangiomatosis
Item
known pulmonary veno-occlusive disease, or pulmonary capillary hemangiomatosis,
boolean
C0034091 (UMLS CUI [1])
C0340548 (UMLS CUI [2])
Obstructive Lung Disease Moderate | Obstructive Lung Disease Severe | FEV1/FVC percent post bronchodilator | Percent predicted FEV1 post bronchodilator
Item
moderate to severe obstructive lung disease: forced expiratory volume in 1 second/forced vital capacity (fev1/fvc) < 70% and fev1 < 65% of predicted value after bronchodilator administration,
boolean
C0600260 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0600260 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0730560 (UMLS CUI [3,1])
C2599594 (UMLS CUI [3,2])
C0730561 (UMLS CUI [4,1])
C2599594 (UMLS CUI [4,2])
Restrictive lung disease Moderate | Restrictive lung disease Severe | Percent Predicted Total Lung Capacity
Item
moderate to severe restrictive lung disease: total lung capacity (tlc) < 60% of predicted value,
boolean
C0085581 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0085581 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C3828589 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding women,
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Systemic hypertension | Systolic Pressure Measurement Repeated | Diastolic blood pressure Measurement Repeated
Item
systemic hypertension (systolic blood pressure > 160 mmhg or diastolic blood pressure > 100 mmhg on repeated measurement),
boolean
C0020538 (UMLS CUI [1])
C0871470 (UMLS CUI [2,1])
C0242485 (UMLS CUI [2,2])
C0205341 (UMLS CUI [2,3])
C0428883 (UMLS CUI [3,1])
C0242485 (UMLS CUI [3,2])
C0205341 (UMLS CUI [3,3])
Systolic Pressure
Item
systolic blood pressure < 95 mmhg,
boolean
C0871470 (UMLS CUI [1])
Hepatic impairment Moderate Child-Pugh Classification | Hepatic impairment Severe Child-Pugh Classification
Item
moderate to severe hepatic impairment, i.e., child-pugh class b or c,
boolean
C0948807 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C4050412 (UMLS CUI [1,3])
C0948807 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C4050412 (UMLS CUI [2,3])
Chronic Kidney Insufficiency | Creatinine measurement, serum | Dialysis Continuous
Item
chronic renal insufficiency defined by serum creatinine > 2.5 mg/dl (221 μmol/l) or ongoing dialysis,
boolean
C0403447 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0011946 (UMLS CUI [3,1])
C0549178 (UMLS CUI [3,2])
Blood Coagulation Disorder | Hemorrhage
Item
clinically relevant bleeding disorder or active bleeding,
boolean
C0005779 (UMLS CUI [1])
C0019080 (UMLS CUI [2])
Medical contraindication Bosentan | Medical contraindication Ambrisentan | Medical contraindication Sildenafil
Item
for those patients on monotherapy, any contraindication to bosentan, ambrisentan, or sildenafil, according to product label,
boolean
C1301624 (UMLS CUI [1,1])
C0252643 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C1176329 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0529793 (UMLS CUI [3,2])
Hypersensitivity Iloprost | Hypersensitivity Iloprost Excipient
Item
known hypersensitivity to iloprost or any of its excipients.
boolean
C0020517 (UMLS CUI [1,1])
C0079594 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0079594 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
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