ID

40848

Description

A 48-week Study of the Effect of Dual Therapy (Inhaled Treprostinil and Tadafafil) Versus Monotherapy (Tadalafil), 2 FDA Approved Pulmonary Hypertension Medications; ODM derived from: https://clinicaltrials.gov/show/NCT01305252

Link

https://clinicaltrials.gov/show/NCT01305252

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 NCT01305252

English

Eligibility Hypertension, Pulmonary NCT01305252

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age 18 and < 75 years at baseline visit.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. diagnosis of idiopathic pah, heritable pah (including hereditary hemorrhagic telangiectasia), associated pah (including collagen vascular disorders, drug+toxin exposure, repaired congenital heart disease repaired > 5 years, portopulmonary disease, and human immunodeficiency virus (hiv) infection not on protease inhibitor).
Description

Idiopathic pulmonary arterial hypertension | Heritable pulmonary arterial hypertension | Hereditary hemorrhagic telangiectasia | Pulmonary arterial hypertension Association | Collagen-vascular disease | Exposure to Drugs | Exposure to Toxin | Congenital heart disease Repaired | Portopulmonary hypertension | HIV Infection | Protease Inhibitors Absent

Data type

boolean

Alias
UMLS CUI [1]
C3203102
UMLS CUI [2]
C0340543
UMLS CUI [3]
C0039445
UMLS CUI [4,1]
C2973725
UMLS CUI [4,2]
C0439849
UMLS CUI [5]
C0262428
UMLS CUI [6,1]
C0332157
UMLS CUI [6,2]
C0242508
UMLS CUI [7,1]
C0332157
UMLS CUI [7,2]
C0040549
UMLS CUI [8,1]
C0152021
UMLS CUI [8,2]
C0205340
UMLS CUI [9]
C1868851
UMLS CUI [10]
C0019693
UMLS CUI [11,1]
C0033607
UMLS CUI [11,2]
C0332197
3. pah treatment naïve including any prostacycline, endothelin receptor antagonist, or phosphodiesterase inhibitors within 12 months prior to enrollment.
Description

Pulmonary arterial hypertension Therapy naive | Prostacyclin Absent | Endothelin receptor antagonist Absent | Phosphodiesterase Inhibitors Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C2973725
UMLS CUI [1,2]
C0919936
UMLS CUI [2,1]
C0033567
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C1134681
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0031638
UMLS CUI [4,2]
C0332197
4. previous right heart catheterization that documented:
Description

Catheterization of right heart

Data type

boolean

Alias
UMLS CUI [1]
C0189896
1. mean pap; 25 mmhg.
Description

Mean pulmonary arterial pressure

Data type

boolean

Alias
UMLS CUI [1]
C3854605
2. pulmonary capillary wedge pressure < 15 mmhg.
Description

Pulmonary Capillary Wedge Pressure

Data type

boolean

Alias
UMLS CUI [1]
C0086879
3. pulmonary vascular resistance; 3.0 wood units or 240 dynes/sec/cm5 5.6mw distances; 150 m and < 450 meters.
Description

Pulmonary Vascular Resistance Wood units | Pulmonary Vascular Resistance | 6 Minute Walk Functional Test Distance m

Data type

boolean

Alias
UMLS CUI [1,1]
C0456261
UMLS CUI [1,2]
C0439525
UMLS CUI [2]
C0456261
UMLS CUI [3,1]
C3900196
UMLS CUI [3,2]
C0012751
UMLS CUI [3,3]
C0475209
6. who functional class ii or iii as judged by principal investigators.
Description

WHO classification

Data type

boolean

Alias
UMLS CUI [1]
C4267671
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. group ii - v pulmonary hypertension.
Description

Group Number Pulmonary Hypertension

Data type

boolean

Alias
UMLS CUI [1,1]
C0441833
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C0020542
2. pah with unrepaired congenital heart defect.
Description

Pulmonary arterial hypertension Associated with Congenital Heart Defects | Repair Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C2973725
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0018798
UMLS CUI [2,1]
C4319951
UMLS CUI [2,2]
C0332268
3. current or prior pah treatments within the last 6-12 months including experimental pah therapies (including but not limited to tyrosine kinase inhibitors, rho-kinase inhibitors, phosphodiesterase inhibitors, prostacycline, or cgmp modulators).
Description

Therapy Pulmonary arterial hypertension | Investigational Therapy Pulmonary arterial hypertension | Protein-tyrosine kinase inhibitor | Rho Kinase Inhibitors | Phosphodiesterase Inhibitors | Epoprostenol | Cyclic GMP drug modulation

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2973725
UMLS CUI [2,1]
C0949266
UMLS CUI [2,2]
C2973725
UMLS CUI [3]
C1268567
UMLS CUI [4]
C4551434
UMLS CUI [5]
C0031638
UMLS CUI [6]
C0033567
UMLS CUI [7,1]
C0018338
UMLS CUI [7,2]
C0279532
4. tlc < 60% predicted; if tlc b/w 60 and 70% predicted, high resolution computed tomography must be available to exclude significant interstitial lung disease.
Description

Percent Predicted Total Lung Capacity

Data type

boolean

Alias
UMLS CUI [1]
C3828589
5. fev1 / fvc < 70% predicted and fev1 < 60% predicted
Description

Percent Predicted FEV1/FVC | Percent predicted FEV1

Data type

boolean

Alias
UMLS CUI [1]
C3828600
UMLS CUI [2]
C0730561
6. significant left-sided heart disease (based on pre-trial echocardiogram):
Description

Heart Disease Left sided Echocardiography

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0443246
UMLS CUI [1,3]
C0013516
1. significant aortic or mitral valve disease
Description

Aortic valve disorder | Disease of mitral valve

Data type

boolean

Alias
UMLS CUI [1]
C1260873
UMLS CUI [2]
C0026265
2. diastolic dysfunction ; grade ii c.lv systolic function < 45%
Description

Diastolic dysfunction Grade | Left ventricle Reduced systolic function

Data type

boolean

Alias
UMLS CUI [1,1]
C0520863
UMLS CUI [1,2]
C0441800
UMLS CUI [2,1]
C0225897
UMLS CUI [2,2]
C4025008
d. pericardial constriction e. restrictive cardiomyopathy f. significant coronary disease with demonstrable ischemia
Description

Pericardial constriction | Restrictive cardiomyopathy | Coronary disease with Ischemia

Data type

boolean

Alias
UMLS CUI [1]
C0240709
UMLS CUI [2]
C0007196
UMLS CUI [3,1]
C0010068
UMLS CUI [3,2]
C0332287
UMLS CUI [3,3]
C0022116
7. chronic renal insufficiency defined as an estimated creatinine clearance < 30 ml/min (by mdrd equation)
Description

Chronic Kidney Insufficiency | Estimated creatine clearance MDRD formula

Data type

boolean

Alias
UMLS CUI [1]
C0403447
UMLS CUI [2,1]
C1273051
UMLS CUI [2,2]
C3839656
8. current atrial arrhythmias
Description

Atrial arrhythmia

Data type

boolean

Alias
UMLS CUI [1]
C0085611
9. uncontrolled systemic hypertension: sbp > 160 mm or dbp > 100mm
Description

Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
10. severe hypotension: sbp < 80 mmhg.
Description

Hypotension, severe | Systolic Pressure

Data type

boolean

Alias
UMLS CUI [1]
C2678378
UMLS CUI [2]
C0871470
11. pregnant or breast-feeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
12. psychiatric, addictive, or other disorder that compromises patient's ability to provide informed consent, follow study protocol, and adhere to treatment instructions
Description

Mental disorders | Addictive Behavior | Other medical condition At risk Informed Consent | Other medical condition At risk Study Protocol | Other medical condition At risk Treatment Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0004936
UMLS CUI [2]
C0085281
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C1444641
UMLS CUI [3,3]
C0021430
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C1444641
UMLS CUI [4,3]
C2348563
UMLS CUI [5,1]
C3843040
UMLS CUI [5,2]
C1444641
UMLS CUI [5,3]
C4319828
13. co-morbid conditions that would impair a patient's exercise performance and ability to assess who functional class, including but not limited to chronic low-back pain or peripheral musculoskeletal problems.
Description

Comorbidity Impairing Exercise | Comorbidity Impairing WHO classification | Chronic low back pain | Musculoskeletal problem Peripheral

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0221099
UMLS CUI [1,3]
C0015259
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0221099
UMLS CUI [2,3]
C4267671
UMLS CUI [3]
C0457949
UMLS CUI [4,1]
C0026859
UMLS CUI [4,2]
C0205100
14. contraindications for magnetic resonance imaging, including significant claustrophobia, implanted metallic objects, or others as per appendix x).
Description

Medical contraindication Magnetic Resonance Imaging | Claustrophobia | Metallic implant

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
UMLS CUI [2]
C0008909
UMLS CUI [3]
C3693688
15. known allergy to treprostinil or tadalafil.
Description

Hypersensitivity Treprostinil | Hypersensitivity Tadalafil

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1145760
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1176316
16. active oral nitrate use.
Description

Nitrate Oral

Data type

boolean

Alias
UMLS CUI [1,1]
C0028125
UMLS CUI [1,2]
C1527415
17. diabetes mellitus.
Description

Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0011849
18. planned initiation of cardiac or pulmonary rehabilitation during period of study.
Description

Cardiac rehabilitation Planned | Pulmonary rehabilitation Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0700431
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C0199529
UMLS CUI [2,2]
C1301732
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Similar models

Eligibility Hypertension, Pulmonary NCT01305252

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. age 18 and < 75 years at baseline visit.
boolean
C0001779 (UMLS CUI [1])
Idiopathic pulmonary arterial hypertension | Heritable pulmonary arterial hypertension | Hereditary hemorrhagic telangiectasia | Pulmonary arterial hypertension Association | Collagen-vascular disease | Exposure to Drugs | Exposure to Toxin | Congenital heart disease Repaired | Portopulmonary hypertension | HIV Infection | Protease Inhibitors Absent
Item
2. diagnosis of idiopathic pah, heritable pah (including hereditary hemorrhagic telangiectasia), associated pah (including collagen vascular disorders, drug+toxin exposure, repaired congenital heart disease repaired > 5 years, portopulmonary disease, and human immunodeficiency virus (hiv) infection not on protease inhibitor).
boolean
C3203102 (UMLS CUI [1])
C0340543 (UMLS CUI [2])
C0039445 (UMLS CUI [3])
C2973725 (UMLS CUI [4,1])
C0439849 (UMLS CUI [4,2])
C0262428 (UMLS CUI [5])
C0332157 (UMLS CUI [6,1])
C0242508 (UMLS CUI [6,2])
C0332157 (UMLS CUI [7,1])
C0040549 (UMLS CUI [7,2])
C0152021 (UMLS CUI [8,1])
C0205340 (UMLS CUI [8,2])
C1868851 (UMLS CUI [9])
C0019693 (UMLS CUI [10])
C0033607 (UMLS CUI [11,1])
C0332197 (UMLS CUI [11,2])
Pulmonary arterial hypertension Therapy naive | Prostacyclin Absent | Endothelin receptor antagonist Absent | Phosphodiesterase Inhibitors Absent
Item
3. pah treatment naïve including any prostacycline, endothelin receptor antagonist, or phosphodiesterase inhibitors within 12 months prior to enrollment.
boolean
C2973725 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
C0033567 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1134681 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0031638 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Catheterization of right heart
Item
4. previous right heart catheterization that documented:
boolean
C0189896 (UMLS CUI [1])
Mean pulmonary arterial pressure
Item
1. mean pap; 25 mmhg.
boolean
C3854605 (UMLS CUI [1])
Pulmonary Capillary Wedge Pressure
Item
2. pulmonary capillary wedge pressure < 15 mmhg.
boolean
C0086879 (UMLS CUI [1])
Pulmonary Vascular Resistance Wood units | Pulmonary Vascular Resistance | 6 Minute Walk Functional Test Distance m
Item
3. pulmonary vascular resistance; 3.0 wood units or 240 dynes/sec/cm5 5.6mw distances; 150 m and < 450 meters.
boolean
C0456261 (UMLS CUI [1,1])
C0439525 (UMLS CUI [1,2])
C0456261 (UMLS CUI [2])
C3900196 (UMLS CUI [3,1])
C0012751 (UMLS CUI [3,2])
C0475209 (UMLS CUI [3,3])
WHO classification
Item
6. who functional class ii or iii as judged by principal investigators.
boolean
C4267671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Item Group
C0680251 (UMLS CUI)
Group Number Pulmonary Hypertension
Item
1. group ii - v pulmonary hypertension.
boolean
C0441833 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0020542 (UMLS CUI [1,3])
Pulmonary arterial hypertension Associated with Congenital Heart Defects | Repair Lacking
Item
2. pah with unrepaired congenital heart defect.
boolean
C2973725 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0018798 (UMLS CUI [1,3])
C4319951 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
Therapy Pulmonary arterial hypertension | Investigational Therapy Pulmonary arterial hypertension | Protein-tyrosine kinase inhibitor | Rho Kinase Inhibitors | Phosphodiesterase Inhibitors | Epoprostenol | Cyclic GMP drug modulation
Item
3. current or prior pah treatments within the last 6-12 months including experimental pah therapies (including but not limited to tyrosine kinase inhibitors, rho-kinase inhibitors, phosphodiesterase inhibitors, prostacycline, or cgmp modulators).
boolean
C0087111 (UMLS CUI [1,1])
C2973725 (UMLS CUI [1,2])
C0949266 (UMLS CUI [2,1])
C2973725 (UMLS CUI [2,2])
C1268567 (UMLS CUI [3])
C4551434 (UMLS CUI [4])
C0031638 (UMLS CUI [5])
C0033567 (UMLS CUI [6])
C0018338 (UMLS CUI [7,1])
C0279532 (UMLS CUI [7,2])
Percent Predicted Total Lung Capacity
Item
4. tlc < 60% predicted; if tlc b/w 60 and 70% predicted, high resolution computed tomography must be available to exclude significant interstitial lung disease.
boolean
C3828589 (UMLS CUI [1])
Percent Predicted FEV1/FVC | Percent predicted FEV1
Item
5. fev1 / fvc < 70% predicted and fev1 < 60% predicted
boolean
C3828600 (UMLS CUI [1])
C0730561 (UMLS CUI [2])
Heart Disease Left sided Echocardiography
Item
6. significant left-sided heart disease (based on pre-trial echocardiogram):
boolean
C0018799 (UMLS CUI [1,1])
C0443246 (UMLS CUI [1,2])
C0013516 (UMLS CUI [1,3])
Aortic valve disorder | Disease of mitral valve
Item
1. significant aortic or mitral valve disease
boolean
C1260873 (UMLS CUI [1])
C0026265 (UMLS CUI [2])
Diastolic dysfunction Grade | Left ventricle Reduced systolic function
Item
2. diastolic dysfunction ; grade ii c.lv systolic function < 45%
boolean
C0520863 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0225897 (UMLS CUI [2,1])
C4025008 (UMLS CUI [2,2])
Pericardial constriction | Restrictive cardiomyopathy | Coronary disease with Ischemia
Item
d. pericardial constriction e. restrictive cardiomyopathy f. significant coronary disease with demonstrable ischemia
boolean
C0240709 (UMLS CUI [1])
C0007196 (UMLS CUI [2])
C0010068 (UMLS CUI [3,1])
C0332287 (UMLS CUI [3,2])
C0022116 (UMLS CUI [3,3])
Chronic Kidney Insufficiency | Estimated creatine clearance MDRD formula
Item
7. chronic renal insufficiency defined as an estimated creatinine clearance < 30 ml/min (by mdrd equation)
boolean
C0403447 (UMLS CUI [1])
C1273051 (UMLS CUI [2,1])
C3839656 (UMLS CUI [2,2])
Atrial arrhythmia
Item
8. current atrial arrhythmias
boolean
C0085611 (UMLS CUI [1])
Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure
Item
9. uncontrolled systemic hypertension: sbp > 160 mm or dbp > 100mm
boolean
C1868885 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Hypotension, severe | Systolic Pressure
Item
10. severe hypotension: sbp < 80 mmhg.
boolean
C2678378 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
11. pregnant or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Mental disorders | Addictive Behavior | Other medical condition At risk Informed Consent | Other medical condition At risk Study Protocol | Other medical condition At risk Treatment Compliance
Item
12. psychiatric, addictive, or other disorder that compromises patient's ability to provide informed consent, follow study protocol, and adhere to treatment instructions
boolean
C0004936 (UMLS CUI [1])
C0085281 (UMLS CUI [2])
C3843040 (UMLS CUI [3,1])
C1444641 (UMLS CUI [3,2])
C0021430 (UMLS CUI [3,3])
C3843040 (UMLS CUI [4,1])
C1444641 (UMLS CUI [4,2])
C2348563 (UMLS CUI [4,3])
C3843040 (UMLS CUI [5,1])
C1444641 (UMLS CUI [5,2])
C4319828 (UMLS CUI [5,3])
Comorbidity Impairing Exercise | Comorbidity Impairing WHO classification | Chronic low back pain | Musculoskeletal problem Peripheral
Item
13. co-morbid conditions that would impair a patient's exercise performance and ability to assess who functional class, including but not limited to chronic low-back pain or peripheral musculoskeletal problems.
boolean
C0009488 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C0015259 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C0221099 (UMLS CUI [2,2])
C4267671 (UMLS CUI [2,3])
C0457949 (UMLS CUI [3])
C0026859 (UMLS CUI [4,1])
C0205100 (UMLS CUI [4,2])
Medical contraindication Magnetic Resonance Imaging | Claustrophobia | Metallic implant
Item
14. contraindications for magnetic resonance imaging, including significant claustrophobia, implanted metallic objects, or others as per appendix x).
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0008909 (UMLS CUI [2])
C3693688 (UMLS CUI [3])
Hypersensitivity Treprostinil | Hypersensitivity Tadalafil
Item
15. known allergy to treprostinil or tadalafil.
boolean
C0020517 (UMLS CUI [1,1])
C1145760 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1176316 (UMLS CUI [2,2])
Nitrate Oral
Item
16. active oral nitrate use.
boolean
C0028125 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
Diabetes Mellitus
Item
17. diabetes mellitus.
boolean
C0011849 (UMLS CUI [1])
Cardiac rehabilitation Planned | Pulmonary rehabilitation Planned
Item
18. planned initiation of cardiac or pulmonary rehabilitation during period of study.
boolean
C0700431 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0199529 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
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