ID

40849

Description

Efficacy and Safety of Ambrisentan in Children 8-18yrs; ODM derived from: https://clinicaltrials.gov/show/NCT01332331

Link

https://clinicaltrials.gov/show/NCT01332331

Keywords

Versions (1)
  1. 5/25/20 5/25/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 25, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension, Pulmonary NCT01332331

English

Eligibility Hypertension, Pulmonary NCT01332331

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
current diagnosis of pah (who group 1) with who class ii or iii symptoms in one of the following categories: idiopathic, heritable [familial], secondary to connective tissue disease (e.g., limited scleroderma, diffuse scleroderma, mixed connective tissue disease (ctd), systemic lupus erythematosus, or overlap syndrome), or persistent pah despite surgical repair (at least 6 months prior to the screening visit) of atrial septal defects, ventricular septal defects, atrio-ventricular septal defects, and persistent patent ductus.
Description

Pulmonary arterial hypertension | Symptoms WHO classification | Idiopathic pulmonary arterial hypertension | Familial pulmonary hypertension | Secondary to Connective Tissue Disease | Scleroderma, Limited | Diffuse Scleroderma | Mixed Connective Tissue Disease | Lupus Erythematosus, Systemic | Overlap syndrome | Persistent pulmonary hypertension | Surgical repair Atrial Septal Defects | Surgical repair Ventricular Septal Defects | Surgical repair Atrioventricular Septal Defect | Surgical repair Patent ductus arteriosus Persistent

Data type

boolean

Alias
UMLS CUI [1]
C2973725
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C4267671
UMLS CUI [3]
C3203102
UMLS CUI [4]
C0340543
UMLS CUI [5,1]
C0175668
UMLS CUI [5,2]
C0009782
UMLS CUI [6]
C0748540
UMLS CUI [7]
C1258104
UMLS CUI [8]
C0026272
UMLS CUI [9]
C0024141
UMLS CUI [10]
C0410000
UMLS CUI [11]
C1135361
UMLS CUI [12,1]
C0374711
UMLS CUI [12,2]
C0018817
UMLS CUI [13,1]
C0374711
UMLS CUI [13,2]
C0018818
UMLS CUI [14,1]
C0374711
UMLS CUI [14,2]
C1389018
UMLS CUI [15,1]
C0374711
UMLS CUI [15,2]
C0013274
UMLS CUI [15,3]
C0205322
have met the following hemodynamic criteria for subjects with right heart catheterization (rhc) when performed as part of the diagnosis or routine care: mean pulmonary arterial pressure (mpap) of >/=25 mmhg, pulmonary vascular resistance (pvr) of >/=240 dyne sec/cm5, left ventricular end diastolic pressure (levdp) or pulmonary capillary wedge pressure (pcwp) of ≤15 mmhg.
Description

Criteria Hemodynamic Fulfill | Catheterization of right heart | Mean pulmonary arterial pressure | Pulmonary Vascular Resistance | Left ventricular end-diastolic pressure measurement | Pulmonary Capillary Wedge Pressure

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C0019010
UMLS CUI [1,3]
C1550543
UMLS CUI [2]
C0189896
UMLS CUI [3]
C3854605
UMLS CUI [4]
C0456261
UMLS CUI [5]
C1171395
UMLS CUI [6]
C0086879
be treatment naïve, have discontinued treatment with another era (e.g., bosentan) at least 1 month previously because of elevated liver function tests (lfts), or have been on a stable dose of drug therapy for pah (e.g., sildenafil or prostacyclin) for at least one month prior to the screening visit.
Description

Therapy naive | Endothelin receptor antagonist Other Discontinued | Bosentan Discontinued | Etiology Increased liver function tests | Pharmacotherapy Stable Pulmonary arterial hypertension | Sildenafil Dose Stable | Epoprostenol Dose Stable

Data type

boolean

Alias
UMLS CUI [1]
C0919936
UMLS CUI [2,1]
C1134681
UMLS CUI [2,2]
C0205394
UMLS CUI [2,3]
C1444662
UMLS CUI [3,1]
C0252643
UMLS CUI [3,2]
C1444662
UMLS CUI [4,1]
C0015127
UMLS CUI [4,2]
C0877359
UMLS CUI [5,1]
C0013216
UMLS CUI [5,2]
C0205360
UMLS CUI [5,3]
C2973725
UMLS CUI [6,1]
C0529793
UMLS CUI [6,2]
C0178602
UMLS CUI [6,3]
C0205360
UMLS CUI [7,1]
C0033567
UMLS CUI [7,2]
C0178602
UMLS CUI [7,3]
C0205360
subjects who discontinued era treatment due to elevated lfts, must have lfts of <3 x upper limit of normal (uln).
Description

Endothelin receptor antagonist Discontinued | Etiology Increased liver function tests | Liver Function Tests Result

Data type

boolean

Alias
UMLS CUI [1,1]
C1134681
UMLS CUI [1,2]
C1444662
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0877359
UMLS CUI [3,1]
C0023901
UMLS CUI [3,2]
C1274040
a female is eligible to participate in this study, as assessed by the investigator, if she is of: a. non-childbearing potential (i.e., physiologically incapable of becoming pregnant); or, b. child-bearing potential - has a negative pregnancy test and is not lactating at the screening and baseline/randomisation visits and, if sexually active, agrees to use 2 reliable methods of contraception from the screening visit until study completion and for at least 30 days following the last dose of study drug.
Description

Gender Childbearing Potential Absent | Childbearing Potential Pregnancy test negative | Childbearing Potential Breast Feeding Absent | Childbearing Potential Sexually active Contraceptive methods Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C3831118
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0427780
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0006147
UMLS CUI [3,3]
C0332197
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0241028
UMLS CUI [4,3]
C0700589
UMLS CUI [4,4]
C1265611
subject or subject's legal guardian is able and willing to give written informed consent. as part of the consent, female subjects of childbearing potential will be informed of the risk of teratogenicity and will need to be counselled in a developmentally appropriate manner on the importance of pregnancy prevention; and male subjects will need to be informed of potential risk of testicular tubular atrophy and aspermia.
Description

Informed Consent | Informed Consent Legal Guardian

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0023226
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
currently taking an era.
Description

Endothelin receptor antagonist

Data type

boolean

Alias
UMLS CUI [1]
C1134681
currently taking cyclosporine a.
Description

Cyclosporine

Data type

boolean

Alias
UMLS CUI [1]
C0010592
body weight is less than 20 kg.
Description

Body Weight

Data type

boolean

Alias
UMLS CUI [1]
C0005910
have not tolerated pah therapy due to adverse effects which may be related to their mechanism of action (e.g., prostanoids, era, pde-5 inhibitors) with the exception of liver abnormalities for those subjects who were receiving another era.
Description

Intolerance Therapy Pulmonary arterial hypertension | Etiology Adverse effects | Prostaglandins | Endothelin receptor antagonist | Phosphodiesterase 5 inhibitor | Exception Abnormality of the liver

Data type

boolean

Alias
UMLS CUI [1,1]
C0231199
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C2973725
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0879626
UMLS CUI [3]
C0033554
UMLS CUI [4]
C1134681
UMLS CUI [5]
C1318700
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C4021780
pregnant or breastfeeding.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
diagnosis of active hepatitis (hepatitis b surface antigen and hepatitis c antibody), or clinically significant hepatic enzyme elevation (i.e., alt, ast or ap >3xuln) at screening.
Description

Hepatitis | Hepatitis B Surface Antigens | Hepatitis C Antibodies | Elevated liver enzymes | Alanine aminotransferase increased | Aspartate aminotransferase increased | Alkaline phosphatase raised

Data type

boolean

Alias
UMLS CUI [1]
C0019158
UMLS CUI [2]
C0019168
UMLS CUI [3]
C0166049
UMLS CUI [4]
C0235996
UMLS CUI [5]
C0151905
UMLS CUI [6]
C0151904
UMLS CUI [7]
C0151849
severe renal impairment (creatinine clearance <30 ml/min) at screening.
Description

Renal Insufficiency Severe | Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0373595
clinically significant fluid retention in the opinion of the investigator.
Description

Body fluid retention

Data type

boolean

Alias
UMLS CUI [1]
C0268000
clinically significant anaemia in the opinion of the investigator.
Description

Anemia

Data type

boolean

Alias
UMLS CUI [1]
C0002871
a known hypersensitivity to the study drug, the metabolites, or formulation excipients.
Description

Hypersensitivity Investigational New Drugs | Hypersensitivity Metabolite | Hypersensitivity Formulation Excipient

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0870883
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0524527
UMLS CUI [3,3]
C0015237
have participated in another trial or have taken another investigational product during the previous 30 days.
Description

Study Subject Participation Status | Clinical Trial | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
UMLS CUI [3]
C0013230
alcohol abuse, illicit drug use within 1 year.
Description

Alcohol abuse | Illicit medication use

Data type

boolean

Alias
UMLS CUI [1]
C0085762
UMLS CUI [2]
C0281875
any concurrent condition or concurrent use of medication that would affect subject safety in the opinion of the investigator.
Description

Condition Affecting Patient safety | Pharmaceutical Preparations Affecting Patient safety

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C1113679
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Similar models

Eligibility Hypertension, Pulmonary NCT01332331

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Pulmonary arterial hypertension | Symptoms WHO classification | Idiopathic pulmonary arterial hypertension | Familial pulmonary hypertension | Secondary to Connective Tissue Disease | Scleroderma, Limited | Diffuse Scleroderma | Mixed Connective Tissue Disease | Lupus Erythematosus, Systemic | Overlap syndrome | Persistent pulmonary hypertension | Surgical repair Atrial Septal Defects | Surgical repair Ventricular Septal Defects | Surgical repair Atrioventricular Septal Defect | Surgical repair Patent ductus arteriosus Persistent
Item
current diagnosis of pah (who group 1) with who class ii or iii symptoms in one of the following categories: idiopathic, heritable [familial], secondary to connective tissue disease (e.g., limited scleroderma, diffuse scleroderma, mixed connective tissue disease (ctd), systemic lupus erythematosus, or overlap syndrome), or persistent pah despite surgical repair (at least 6 months prior to the screening visit) of atrial septal defects, ventricular septal defects, atrio-ventricular septal defects, and persistent patent ductus.
boolean
C2973725 (UMLS CUI [1])
C1457887 (UMLS CUI [2,1])
C4267671 (UMLS CUI [2,2])
C3203102 (UMLS CUI [3])
C0340543 (UMLS CUI [4])
C0175668 (UMLS CUI [5,1])
C0009782 (UMLS CUI [5,2])
C0748540 (UMLS CUI [6])
C1258104 (UMLS CUI [7])
C0026272 (UMLS CUI [8])
C0024141 (UMLS CUI [9])
C0410000 (UMLS CUI [10])
C1135361 (UMLS CUI [11])
C0374711 (UMLS CUI [12,1])
C0018817 (UMLS CUI [12,2])
C0374711 (UMLS CUI [13,1])
C0018818 (UMLS CUI [13,2])
C0374711 (UMLS CUI [14,1])
C1389018 (UMLS CUI [14,2])
C0374711 (UMLS CUI [15,1])
C0013274 (UMLS CUI [15,2])
C0205322 (UMLS CUI [15,3])
Criteria Hemodynamic Fulfill | Catheterization of right heart | Mean pulmonary arterial pressure | Pulmonary Vascular Resistance | Left ventricular end-diastolic pressure measurement | Pulmonary Capillary Wedge Pressure
Item
have met the following hemodynamic criteria for subjects with right heart catheterization (rhc) when performed as part of the diagnosis or routine care: mean pulmonary arterial pressure (mpap) of >/=25 mmhg, pulmonary vascular resistance (pvr) of >/=240 dyne sec/cm5, left ventricular end diastolic pressure (levdp) or pulmonary capillary wedge pressure (pcwp) of ≤15 mmhg.
boolean
C0243161 (UMLS CUI [1,1])
C0019010 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
C0189896 (UMLS CUI [2])
C3854605 (UMLS CUI [3])
C0456261 (UMLS CUI [4])
C1171395 (UMLS CUI [5])
C0086879 (UMLS CUI [6])
Therapy naive | Endothelin receptor antagonist Other Discontinued | Bosentan Discontinued | Etiology Increased liver function tests | Pharmacotherapy Stable Pulmonary arterial hypertension | Sildenafil Dose Stable | Epoprostenol Dose Stable
Item
be treatment naïve, have discontinued treatment with another era (e.g., bosentan) at least 1 month previously because of elevated liver function tests (lfts), or have been on a stable dose of drug therapy for pah (e.g., sildenafil or prostacyclin) for at least one month prior to the screening visit.
boolean
C0919936 (UMLS CUI [1])
C1134681 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C1444662 (UMLS CUI [2,3])
C0252643 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
C0015127 (UMLS CUI [4,1])
C0877359 (UMLS CUI [4,2])
C0013216 (UMLS CUI [5,1])
C0205360 (UMLS CUI [5,2])
C2973725 (UMLS CUI [5,3])
C0529793 (UMLS CUI [6,1])
C0178602 (UMLS CUI [6,2])
C0205360 (UMLS CUI [6,3])
C0033567 (UMLS CUI [7,1])
C0178602 (UMLS CUI [7,2])
C0205360 (UMLS CUI [7,3])
Endothelin receptor antagonist Discontinued | Etiology Increased liver function tests | Liver Function Tests Result
Item
subjects who discontinued era treatment due to elevated lfts, must have lfts of <3 x upper limit of normal (uln).
boolean
C1134681 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0015127 (UMLS CUI [2,1])
C0877359 (UMLS CUI [2,2])
C0023901 (UMLS CUI [3,1])
C1274040 (UMLS CUI [3,2])
Gender Childbearing Potential Absent | Childbearing Potential Pregnancy test negative | Childbearing Potential Breast Feeding Absent | Childbearing Potential Sexually active Contraceptive methods Quantity
Item
a female is eligible to participate in this study, as assessed by the investigator, if she is of: a. non-childbearing potential (i.e., physiologically incapable of becoming pregnant); or, b. child-bearing potential - has a negative pregnancy test and is not lactating at the screening and baseline/randomisation visits and, if sexually active, agrees to use 2 reliable methods of contraception from the screening visit until study completion and for at least 30 days following the last dose of study drug.
boolean
C0079399 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0427780 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0006147 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C3831118 (UMLS CUI [4,1])
C0241028 (UMLS CUI [4,2])
C0700589 (UMLS CUI [4,3])
C1265611 (UMLS CUI [4,4])
Informed Consent | Informed Consent Legal Guardian
Item
subject or subject's legal guardian is able and willing to give written informed consent. as part of the consent, female subjects of childbearing potential will be informed of the risk of teratogenicity and will need to be counselled in a developmentally appropriate manner on the importance of pregnancy prevention; and male subjects will need to be informed of potential risk of testicular tubular atrophy and aspermia.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0023226 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Endothelin receptor antagonist
Item
currently taking an era.
boolean
C1134681 (UMLS CUI [1])
Cyclosporine
Item
currently taking cyclosporine a.
boolean
C0010592 (UMLS CUI [1])
Body Weight
Item
body weight is less than 20 kg.
boolean
C0005910 (UMLS CUI [1])
Intolerance Therapy Pulmonary arterial hypertension | Etiology Adverse effects | Prostaglandins | Endothelin receptor antagonist | Phosphodiesterase 5 inhibitor | Exception Abnormality of the liver
Item
have not tolerated pah therapy due to adverse effects which may be related to their mechanism of action (e.g., prostanoids, era, pde-5 inhibitors) with the exception of liver abnormalities for those subjects who were receiving another era.
boolean
C0231199 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C2973725 (UMLS CUI [1,3])
C0015127 (UMLS CUI [2,1])
C0879626 (UMLS CUI [2,2])
C0033554 (UMLS CUI [3])
C1134681 (UMLS CUI [4])
C1318700 (UMLS CUI [5])
C1705847 (UMLS CUI [6,1])
C4021780 (UMLS CUI [6,2])
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hepatitis | Hepatitis B Surface Antigens | Hepatitis C Antibodies | Elevated liver enzymes | Alanine aminotransferase increased | Aspartate aminotransferase increased | Alkaline phosphatase raised
Item
diagnosis of active hepatitis (hepatitis b surface antigen and hepatitis c antibody), or clinically significant hepatic enzyme elevation (i.e., alt, ast or ap >3xuln) at screening.
boolean
C0019158 (UMLS CUI [1])
C0019168 (UMLS CUI [2])
C0166049 (UMLS CUI [3])
C0235996 (UMLS CUI [4])
C0151905 (UMLS CUI [5])
C0151904 (UMLS CUI [6])
C0151849 (UMLS CUI [7])
Renal Insufficiency Severe | Creatinine clearance measurement
Item
severe renal impairment (creatinine clearance <30 ml/min) at screening.
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0373595 (UMLS CUI [2])
Body fluid retention
Item
clinically significant fluid retention in the opinion of the investigator.
boolean
C0268000 (UMLS CUI [1])
Anemia
Item
clinically significant anaemia in the opinion of the investigator.
boolean
C0002871 (UMLS CUI [1])
Hypersensitivity Investigational New Drugs | Hypersensitivity Metabolite | Hypersensitivity Formulation Excipient
Item
a known hypersensitivity to the study drug, the metabolites, or formulation excipients.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0870883 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0524527 (UMLS CUI [3,2])
C0015237 (UMLS CUI [3,3])
Study Subject Participation Status | Clinical Trial | Investigational New Drugs
Item
have participated in another trial or have taken another investigational product during the previous 30 days.
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
Alcohol abuse | Illicit medication use
Item
alcohol abuse, illicit drug use within 1 year.
boolean
C0085762 (UMLS CUI [1])
C0281875 (UMLS CUI [2])
Condition Affecting Patient safety | Pharmaceutical Preparations Affecting Patient safety
Item
any concurrent condition or concurrent use of medication that would affect subject safety in the opinion of the investigator.
boolean
C0348080 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
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