ID

30052

Beschrijving

Interaction Study in Patients With Pulmonary Hypertension and Stable Treatment of Sildenafil 20 mg TID; ODM derived from: https://clinicaltrials.gov/show/NCT00680654

Link

https://clinicaltrials.gov/show/NCT00680654

Trefwoorden

Versies (1)
  1. 06-05-18 06-05-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

6 mei 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Hypertension, Pulmonary NCT00680654

Engels

Eligibility Hypertension, Pulmonary NCT00680654

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with pulmonary hypertension stable for the last 6 weeks
Beschrijving

Pulmonary Hypertension Stable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020542
UMLS CUI [1,2]
C0205360
treated with sildenafil 3 × 20 mg
Beschrijving

Sildenafil Dosage

Datatype

boolean

Alias
UMLS CUI [1,1]
C0529793
UMLS CUI [1,2]
C0178602
undergoing routine invasive diagnostics.
Beschrijving

Diagnostic tests Routine

Datatype

boolean

Alias
UMLS CUI [1,1]
C0086143
UMLS CUI [1,2]
C0205547
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
pre-existing lung disease other than pulmonary arterial hypertension,
Beschrijving

Lung disease Pre-existing | Exception Pulmonary arterial hypertension

Datatype

boolean

Alias
UMLS CUI [1,1]
C0024115
UMLS CUI [1,2]
C2347662
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C2973725
acute or severe chronic left heart failure,
Beschrijving

Chronic left-sided heart failure Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C0264726
UMLS CUI [1,2]
C0205082
severe coronary artery disease,
Beschrijving

Coronary Artery Disease Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C1956346
UMLS CUI [1,2]
C0205082
uncontrolled arterial hypertension;
Beschrijving

Uncontrolled hypertension

Datatype

boolean

Alias
UMLS CUI [1]
C1868885
congenital or acquired valvular or myocardial disease except acquired tricuspid valve insufficiency due to pulmonary hypertension,
Beschrijving

Valvular disease congenital | Valvular disease Acquired | Congenital cardiomyopathy | Cardiomyopathy Acquired | Exception Tricuspid Valve Insufficiency Acquired | Tricuspid Valve Insufficiency Due to Pulmonary Hypertension

Datatype

boolean

Alias
UMLS CUI [1]
C1384986
UMLS CUI [2,1]
C3258293
UMLS CUI [2,2]
C0439661
UMLS CUI [3]
C1391997
UMLS CUI [4,1]
C0878544
UMLS CUI [4,2]
C0439661
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0040961
UMLS CUI [5,3]
C0439661
UMLS CUI [6,1]
C0040961
UMLS CUI [6,2]
C0678226
UMLS CUI [6,3]
C0020542
systolic blood pressure < 100 mmhg, heart rate < 55 bpm or >105 bpm, pao2/fio2 < 50 mmhg,
Beschrijving

Systolic Pressure | Heart rate | PaO2/FiO2 Ratio Measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0018810
UMLS CUI [3]
C3897988
paco2 > 55 mmhg,
Beschrijving

PaCO2 measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0201931
severe hepatic insufficiency,
Beschrijving

Hepatic Insufficiency Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C1306571
UMLS CUI [1,2]
C0205082
severe renal insufficiency,
Beschrijving

Renal Insufficiency Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205082
administration of strong cyp3a4 inhibitors or inductors
Beschrijving

CYP3A4 Inhibitors Strong | CYP3A4 Inducers Strong

Datatype

boolean

Alias
UMLS CUI [1,1]
C3850053
UMLS CUI [1,2]
C0442821
UMLS CUI [2,1]
C3850041
UMLS CUI [2,2]
C0442821
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Similar models

Eligibility Hypertension, Pulmonary NCT00680654

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Pulmonary Hypertension Stable
Item
patients with pulmonary hypertension stable for the last 6 weeks
boolean
C0020542 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Sildenafil Dosage
Item
treated with sildenafil 3 × 20 mg
boolean
C0529793 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Diagnostic tests Routine
Item
undergoing routine invasive diagnostics.
boolean
C0086143 (UMLS CUI [1,1])
C0205547 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Lung disease Pre-existing | Exception Pulmonary arterial hypertension
Item
pre-existing lung disease other than pulmonary arterial hypertension,
boolean
C0024115 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C2973725 (UMLS CUI [2,2])
Chronic left-sided heart failure Severe
Item
acute or severe chronic left heart failure,
boolean
C0264726 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Coronary Artery Disease Severe
Item
severe coronary artery disease,
boolean
C1956346 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Uncontrolled hypertension
Item
uncontrolled arterial hypertension;
boolean
C1868885 (UMLS CUI [1])
Valvular disease congenital | Valvular disease Acquired | Congenital cardiomyopathy | Cardiomyopathy Acquired | Exception Tricuspid Valve Insufficiency Acquired | Tricuspid Valve Insufficiency Due to Pulmonary Hypertension
Item
congenital or acquired valvular or myocardial disease except acquired tricuspid valve insufficiency due to pulmonary hypertension,
boolean
C1384986 (UMLS CUI [1])
C3258293 (UMLS CUI [2,1])
C0439661 (UMLS CUI [2,2])
C1391997 (UMLS CUI [3])
C0878544 (UMLS CUI [4,1])
C0439661 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0040961 (UMLS CUI [5,2])
C0439661 (UMLS CUI [5,3])
C0040961 (UMLS CUI [6,1])
C0678226 (UMLS CUI [6,2])
C0020542 (UMLS CUI [6,3])
Systolic Pressure | Heart rate | PaO2/FiO2 Ratio Measurement
Item
systolic blood pressure < 100 mmhg, heart rate < 55 bpm or >105 bpm, pao2/fio2 < 50 mmhg,
boolean
C0871470 (UMLS CUI [1])
C0018810 (UMLS CUI [2])
C3897988 (UMLS CUI [3])
PaCO2 measurement
Item
paco2 > 55 mmhg,
boolean
C0201931 (UMLS CUI [1])
Hepatic Insufficiency Severe
Item
severe hepatic insufficiency,
boolean
C1306571 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Renal Insufficiency Severe
Item
severe renal insufficiency,
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
CYP3A4 Inhibitors Strong | CYP3A4 Inducers Strong
Item
administration of strong cyp3a4 inhibitors or inductors
boolean
C3850053 (UMLS CUI [1,1])
C0442821 (UMLS CUI [1,2])
C3850041 (UMLS CUI [2,1])
C0442821 (UMLS CUI [2,2])
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