ID

30053

Beschreibung

A Research Study To Assess The Effectiveness And Safety Of Different Doses Of Oral PF-00489791 In The Treatment Of Adult Patients With Pulmonary Arterial Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00853112

Link

https://clinicaltrials.gov/show/NCT00853112

Stichworte

Versionen (1)
  1. 06.05.18 06.05.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

6. Mai 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Hypertension, Pulmonary NCT00853112

Englisch

Eligibility Hypertension, Pulmonary NCT00853112

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
idiopathic or familial pulmonary arterial hypertension (pah)
Beschreibung

Idiopathic pulmonary arterial hypertension | Familial pulmonary arterial hypertension

Datentyp

boolean

Alias
UMLS CUI [1]
C3203102
UMLS CUI [2]
C1701939
mean pap at least 25 mm hg, pcwp < 15 mm hg at rest
Beschreibung

Pulmonary artery mean pressure | Pulmonary Capillary Wedge Pressure At rest

Datentyp

boolean

Alias
UMLS CUI [1]
C0428645
UMLS CUI [2,1]
C0086879
UMLS CUI [2,2]
C0443144
for females of child-bearing potential negative pregnancy test at screening and use of contraception during the study and 4 weeks after its completion
Beschreibung

Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
signed and dated informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
willingness to comply with the study plan and procedures
Beschreibung

Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
pulmonary arterial hypertension (pah)other than idiopathic or familial
Beschreibung

Pulmonary arterial hypertension | Exception Idiopathic pulmonary arterial hypertension | Exception Familial pulmonary arterial hypertension

Datentyp

boolean

Alias
UMLS CUI [1]
C2973725
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C3203102
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1701939
for females, pregnancy or lactation
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
use of specific pah treatments, potent cyp3a4 inhibitors, protease inhibitors, alpha blockers or arginine 30 days prior tio randomization and during the study
Beschreibung

Therapeutic procedure Specific Pulmonary arterial hypertension | CYP3A4 Inhibitors | Protease Inhibitors | Adrenergic alpha-Antagonists | Arginine

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0205369
UMLS CUI [1,3]
C2973725
UMLS CUI [2]
C3850053
UMLS CUI [3]
C0033607
UMLS CUI [4]
C0001641
UMLS CUI [5]
C0003765
change of dose or class of standard background pah therapy, i.e. oxygen, calcium channel blockers, digoxin, diuretics 30 days prior tio randomization and during the study
Beschreibung

Standard therapy Pulmonary arterial hypertension Dosage altered | Standard therapy Pulmonary arterial hypertension Class Changed | Oxygen | Calcium Channel Blockers | Digoxin | Diuretics

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2936643
UMLS CUI [1,2]
C2973725
UMLS CUI [1,3]
C0420247
UMLS CUI [2,1]
C2936643
UMLS CUI [2,2]
C2973725
UMLS CUI [2,3]
C0456387
UMLS CUI [2,4]
C0392747
UMLS CUI [3]
C0030054
UMLS CUI [4]
C0006684
UMLS CUI [5]
C0012265
UMLS CUI [6]
C0012798
large shift in altitude (defined as >5000 feet or 1524 meters) during 90 days prior to baseline visit and/or during the study visit
Beschreibung

Altitude Shift Large

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0002349
UMLS CUI [1,2]
C2347509
UMLS CUI [1,3]
C0549177
subjects with intracardiac shunts and/or serious heart, lung or other health conditions
Beschreibung

Cardiac shunt | Heart condition Serious | Lung Problem Serious | Other health conditions Serious

Datentyp

boolean

Alias
UMLS CUI [1]
C0232180
UMLS CUI [2,1]
C3842523
UMLS CUI [2,2]
C0205404
UMLS CUI [3,1]
C0740941
UMLS CUI [3,2]
C0205404
UMLS CUI [4,1]
C2707304
UMLS CUI [4,2]
C0205404
hiv positive subjects
Beschreibung

HIV Seropositivity

Datentyp

boolean

Alias
UMLS CUI [1]
C0019699
subjects participating in another clinical trial with an investigational drug or device
Beschreibung

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
subjects with degenerative retinal disorders, history of non-arteritic anterior ischemic optic neuropathy or untreated proliferative diabetic retinopathy
Beschreibung

Retinal Diseases degenerative | Nonarteritic anterior ischemic optic neuropathy | Proliferative diabetic retinopathy untreated

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0035309
UMLS CUI [1,2]
C0011164
UMLS CUI [2]
C1852242
UMLS CUI [3,1]
C0154830
UMLS CUI [3,2]
C0332155
allergies and previous intolerance of pde5 inhibitors
Beschreibung

Hypersensitivity Phosphodiesterase 5 inhibitor | Intolerance to Phosphodiesterase 5 inhibitor

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1318700
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C1318700
alcohol or drug abuse
Beschreibung

Substance Use Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
blood donation during the study, or 1 month before or after the study
Beschreibung

Blood Donation

Datentyp

boolean

Alias
UMLS CUI [1]
C0005794
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Ähnliche Modelle

Eligibility Hypertension, Pulmonary NCT00853112

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Idiopathic pulmonary arterial hypertension | Familial pulmonary arterial hypertension
Item
idiopathic or familial pulmonary arterial hypertension (pah)
boolean
C3203102 (UMLS CUI [1])
C1701939 (UMLS CUI [2])
Pulmonary artery mean pressure | Pulmonary Capillary Wedge Pressure At rest
Item
mean pap at least 25 mm hg, pcwp < 15 mm hg at rest
boolean
C0428645 (UMLS CUI [1])
C0086879 (UMLS CUI [2,1])
C0443144 (UMLS CUI [2,2])
Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods
Item
for females of child-bearing potential negative pregnancy test at screening and use of contraception during the study and 4 weeks after its completion
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Informed Consent
Item
signed and dated informed consent
boolean
C0021430 (UMLS CUI [1])
Protocol Compliance
Item
willingness to comply with the study plan and procedures
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pulmonary arterial hypertension | Exception Idiopathic pulmonary arterial hypertension | Exception Familial pulmonary arterial hypertension
Item
pulmonary arterial hypertension (pah)other than idiopathic or familial
boolean
C2973725 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C3203102 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1701939 (UMLS CUI [3,2])
Pregnancy | Breast Feeding
Item
for females, pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Therapeutic procedure Specific Pulmonary arterial hypertension | CYP3A4 Inhibitors | Protease Inhibitors | Adrenergic alpha-Antagonists | Arginine
Item
use of specific pah treatments, potent cyp3a4 inhibitors, protease inhibitors, alpha blockers or arginine 30 days prior tio randomization and during the study
boolean
C0087111 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C2973725 (UMLS CUI [1,3])
C3850053 (UMLS CUI [2])
C0033607 (UMLS CUI [3])
C0001641 (UMLS CUI [4])
C0003765 (UMLS CUI [5])
Standard therapy Pulmonary arterial hypertension Dosage altered | Standard therapy Pulmonary arterial hypertension Class Changed | Oxygen | Calcium Channel Blockers | Digoxin | Diuretics
Item
change of dose or class of standard background pah therapy, i.e. oxygen, calcium channel blockers, digoxin, diuretics 30 days prior tio randomization and during the study
boolean
C2936643 (UMLS CUI [1,1])
C2973725 (UMLS CUI [1,2])
C0420247 (UMLS CUI [1,3])
C2936643 (UMLS CUI [2,1])
C2973725 (UMLS CUI [2,2])
C0456387 (UMLS CUI [2,3])
C0392747 (UMLS CUI [2,4])
C0030054 (UMLS CUI [3])
C0006684 (UMLS CUI [4])
C0012265 (UMLS CUI [5])
C0012798 (UMLS CUI [6])
Altitude Shift Large
Item
large shift in altitude (defined as >5000 feet or 1524 meters) during 90 days prior to baseline visit and/or during the study visit
boolean
C0002349 (UMLS CUI [1,1])
C2347509 (UMLS CUI [1,2])
C0549177 (UMLS CUI [1,3])
Cardiac shunt | Heart condition Serious | Lung Problem Serious | Other health conditions Serious
Item
subjects with intracardiac shunts and/or serious heart, lung or other health conditions
boolean
C0232180 (UMLS CUI [1])
C3842523 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0740941 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C2707304 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
HIV Seropositivity
Item
hiv positive subjects
boolean
C0019699 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
subjects participating in another clinical trial with an investigational drug or device
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
Retinal Diseases degenerative | Nonarteritic anterior ischemic optic neuropathy | Proliferative diabetic retinopathy untreated
Item
subjects with degenerative retinal disorders, history of non-arteritic anterior ischemic optic neuropathy or untreated proliferative diabetic retinopathy
boolean
C0035309 (UMLS CUI [1,1])
C0011164 (UMLS CUI [1,2])
C1852242 (UMLS CUI [2])
C0154830 (UMLS CUI [3,1])
C0332155 (UMLS CUI [3,2])
Hypersensitivity Phosphodiesterase 5 inhibitor | Intolerance to Phosphodiesterase 5 inhibitor
Item
allergies and previous intolerance of pde5 inhibitors
boolean
C0020517 (UMLS CUI [1,1])
C1318700 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C1318700 (UMLS CUI [2,2])
Substance Use Disorders
Item
alcohol or drug abuse
boolean
C0038586 (UMLS CUI [1])
Blood Donation
Item
blood donation during the study, or 1 month before or after the study
boolean
C0005794 (UMLS CUI [1])
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