ID

19111

Description

Safety and Efficacy Study of Sitaxentan Sodium (Thelin™) in Patients With Pulmonary Arterial Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00080457

Link

https://clinicaltrials.gov/show/NCT00080457

Keywords

Versions (1)
  1. 12/5/16 12/5/16 -
Uploaded on

December 5, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Pulmonary Hypertension NCT00080457

English

Eligibility Pulmonary Hypertension NCT00080457

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
have a current diagnosis of symptomatic pah classified by one of the following:
Description

Pulmonary arterial hypertension Symptomatic

Data type

boolean

Alias
UMLS CUI [1,1]
C2973725
UMLS CUI [1,2]
C0231220
1. primary pulmonary hypertension (pph) - also known as idiopathic pulmonary arterial hypertension (ipah);
Description

Idiopathic pulmonary hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0152171
2. pah associated with connective tissue diseases;
Description

Pulmonary arterial hypertension Associated with Connective Tissue Diseases

Data type

boolean

Alias
UMLS CUI [1,1]
C2973725
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0009782
3. pah associated with one of the following congenital heart defects:
Description

Pulmonary arterial hypertension Associated with Congenital Heart Defects

Data type

boolean

Alias
UMLS CUI [1,1]
C2973725
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0018798
1. repaired asd, vsd or pda greater than one year post-operative
Description

Atrioseptoplasty Postoperative | Correction of ventricular septal defect Postoperative | Patent ductus arteriosus repair Postoperative

Data type

boolean

Alias
UMLS CUI [1,1]
C0189965
UMLS CUI [1,2]
C0032790
UMLS CUI [2,1]
C0189969
UMLS CUI [2,2]
C0032790
UMLS CUI [3,1]
C0013274
UMLS CUI [3,2]
C0374711
UMLS CUI [3,3]
C0032790
2. un-repaired secundum asd (with resting oxygen saturation greater than 88 percent in room air measured by oximeter)
Description

Ostium secundum atrial septal defect repair | Oxygen saturation measurement At rest on room air | Measurement Pulse oximeter

Data type

boolean

Alias
UMLS CUI [1,1]
C0344724
UMLS CUI [1,2]
C0374711
UMLS CUI [2,1]
C0523807
UMLS CUI [2,2]
C0443144
UMLS CUI [2,3]
C2709070
UMLS CUI [3,1]
C0242485
UMLS CUI [3,2]
C0182109
world health organization (who) functional class ii, iii, iv
Description

World Health Organization Class Functional

Data type

boolean

Alias
UMLS CUI [1,1]
C0043237
UMLS CUI [1,2]
C0456387
UMLS CUI [1,3]
C0205245
greater than 12 and less than 75 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
women of childbearing potential must be using two forms of medically acceptable contraception (at least one barrier method)
Description

Childbearing Potential Contraceptive methods Quantity | Barrier Contraception Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0004764
UMLS CUI [2,2]
C1265611
have a cardiac catheterization within 6 months before study entry that shows the following values:
Description

Cardiac Catheterization Procedures

Data type

boolean

Alias
UMLS CUI [1]
C0018795
1. mean pulmonary artery pressure (papm) greater than 25 mmhg (at rest),
Description

Mean pulmonary arterial pressure At rest

Data type

boolean

Alias
UMLS CUI [1,1]
C3854605
UMLS CUI [1,2]
C0443144
2. pulmonary capillary wedge pressure (pcwp) or left ventricular-end diastolic pressure less than 15 mmhg, and
Description

Pulmonary Capillary Wedge Pressure | Left ventricular end-diastolic pressure

Data type

boolean

Alias
UMLS CUI [1]
C0086879
UMLS CUI [2]
C0456190
3. pulmonary vascular resistance (pvr) greater than 3 mmhg/l/min.
Description

Pulmonary Vascular Resistance

Data type

boolean

Alias
UMLS CUI [1]
C0456261
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
portal hypertension or chronic liver disease
Description

Hypertension, Portal | Chronic liver disease

Data type

boolean

Alias
UMLS CUI [1]
C0020541
UMLS CUI [2]
C0341439
alt or ast levels greater than 1.5 times the upper limit of normal at the screening visit
Description

Alanine aminotransferase increased | Aspartate aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0151905
UMLS CUI [2]
C0151904
contraindication to treatment with an endothelin receptor antagonist
Description

Medical contraindication Endothelin receptor antagonist

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1134681
recent history of abusing alcohol or illicit drugs
Description

Alcohol abuse | Illicit Drugs abuse

Data type

boolean

Alias
UMLS CUI [1]
C0085762
UMLS CUI [2,1]
C0086190
UMLS CUI [2,2]
C0013146
chronic renal insufficiency
Description

Chronic Kidney Insufficiency

Data type

boolean

Alias
UMLS CUI [1]
C0403447
pregnant or breastfeeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
atrial septostomy within 30 days before study entry
Description

Atrial septostomy

Data type

boolean

Alias
UMLS CUI [1]
C0700586
previous failure on bosentan because of safety concerns of the lack of clinical response
Description

bosentan failed | Clinical Response Lack | Safety Concern

Data type

boolean

Alias
UMLS CUI [1,1]
C0252643
UMLS CUI [1,2]
C0231175
UMLS CUI [2,1]
C4055223
UMLS CUI [2,2]
C0332268
UMLS CUI [3,1]
C0036043
UMLS CUI [3,2]
C2699424
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Similar models

Eligibility Pulmonary Hypertension NCT00080457

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Pulmonary arterial hypertension Symptomatic
Item
have a current diagnosis of symptomatic pah classified by one of the following:
boolean
C2973725 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Idiopathic pulmonary hypertension
Item
1. primary pulmonary hypertension (pph) - also known as idiopathic pulmonary arterial hypertension (ipah);
boolean
C0152171 (UMLS CUI [1])
Pulmonary arterial hypertension Associated with Connective Tissue Diseases
Item
2. pah associated with connective tissue diseases;
boolean
C2973725 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0009782 (UMLS CUI [1,3])
Pulmonary arterial hypertension Associated with Congenital Heart Defects
Item
3. pah associated with one of the following congenital heart defects:
boolean
C2973725 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0018798 (UMLS CUI [1,3])
Atrioseptoplasty Postoperative | Correction of ventricular septal defect Postoperative | Patent ductus arteriosus repair Postoperative
Item
1. repaired asd, vsd or pda greater than one year post-operative
boolean
C0189965 (UMLS CUI [1,1])
C0032790 (UMLS CUI [1,2])
C0189969 (UMLS CUI [2,1])
C0032790 (UMLS CUI [2,2])
C0013274 (UMLS CUI [3,1])
C0374711 (UMLS CUI [3,2])
C0032790 (UMLS CUI [3,3])
Ostium secundum atrial septal defect repair | Oxygen saturation measurement At rest on room air | Measurement Pulse oximeter
Item
2. un-repaired secundum asd (with resting oxygen saturation greater than 88 percent in room air measured by oximeter)
boolean
C0344724 (UMLS CUI [1,1])
C0374711 (UMLS CUI [1,2])
C0523807 (UMLS CUI [2,1])
C0443144 (UMLS CUI [2,2])
C2709070 (UMLS CUI [2,3])
C0242485 (UMLS CUI [3,1])
C0182109 (UMLS CUI [3,2])
World Health Organization Class Functional
Item
world health organization (who) functional class ii, iii, iv
boolean
C0043237 (UMLS CUI [1,1])
C0456387 (UMLS CUI [1,2])
C0205245 (UMLS CUI [1,3])
Age
Item
greater than 12 and less than 75 years of age
boolean
C0001779 (UMLS CUI [1])
Childbearing Potential Contraceptive methods Quantity | Barrier Contraception Quantity
Item
women of childbearing potential must be using two forms of medically acceptable contraception (at least one barrier method)
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0004764 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Cardiac Catheterization Procedures
Item
have a cardiac catheterization within 6 months before study entry that shows the following values:
boolean
C0018795 (UMLS CUI [1])
Mean pulmonary arterial pressure At rest
Item
1. mean pulmonary artery pressure (papm) greater than 25 mmhg (at rest),
boolean
C3854605 (UMLS CUI [1,1])
C0443144 (UMLS CUI [1,2])
Pulmonary Capillary Wedge Pressure | Left ventricular end-diastolic pressure
Item
2. pulmonary capillary wedge pressure (pcwp) or left ventricular-end diastolic pressure less than 15 mmhg, and
boolean
C0086879 (UMLS CUI [1])
C0456190 (UMLS CUI [2])
Pulmonary Vascular Resistance
Item
3. pulmonary vascular resistance (pvr) greater than 3 mmhg/l/min.
boolean
C0456261 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hypertension, Portal | Chronic liver disease
Item
portal hypertension or chronic liver disease
boolean
C0020541 (UMLS CUI [1])
C0341439 (UMLS CUI [2])
Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
alt or ast levels greater than 1.5 times the upper limit of normal at the screening visit
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
Medical contraindication Endothelin receptor antagonist
Item
contraindication to treatment with an endothelin receptor antagonist
boolean
C1301624 (UMLS CUI [1,1])
C1134681 (UMLS CUI [1,2])
Alcohol abuse | Illicit Drugs abuse
Item
recent history of abusing alcohol or illicit drugs
boolean
C0085762 (UMLS CUI [1])
C0086190 (UMLS CUI [2,1])
C0013146 (UMLS CUI [2,2])
Chronic Kidney Insufficiency
Item
chronic renal insufficiency
boolean
C0403447 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Atrial septostomy
Item
atrial septostomy within 30 days before study entry
boolean
C0700586 (UMLS CUI [1])
bosentan failed | Clinical Response Lack | Safety Concern
Item
previous failure on bosentan because of safety concerns of the lack of clinical response
boolean
C0252643 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C4055223 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
C0036043 (UMLS CUI [3,1])
C2699424 (UMLS CUI [3,2])
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