ID

16804

Description

Tadalafil in Subjects With Mild to Moderate Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00157326

Link

https://clinicaltrials.gov/show/NCT00157326

Keywords

Versions (1)
  1. 8/8/16 8/8/16 -
Uploaded on

August 8, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension NCT00157326

English

Eligibility Hypertension NCT00157326

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
have a documented medical history of hypertension.
Description

Hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0020538
have cuff seated diastolic blood pressure values greater than or equal to 95 and less than or equal to 104 mm at study entry
Description

Diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C0428883
have a negative serum pregnancy test at the time of enrollment and agree to use two medically reliable methods of contraception until study completion, if female is of child-bearing potential, between menarche and 1 year post menopause and not surgically sterilized.
Description

Negative serum pregnancy test, contraception

Data type

boolean

Alias
UMLS CUI [1]
C0430060
UMLS CUI [2]
C0700589
are able to comply with study procedures and visits
Description

Patient Compliance

Data type

boolean

Alias
UMLS CUI [1]
C1321605
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
have resistant hypertension or systolic hypertension.
Description

Resistant hypertension or systolic hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0745130
UMLS CUI [2]
C0221155
are obese, defined as having body mass index (bmi) greater than or equal to 35.
Description

Obesity

Data type

boolean

Alias
UMLS CUI [1]
C1305855
are females who are pregnant or breast feeding.
Description

Pregnancy or breast feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
have a history of severe renal insufficiency or significant thyroid, renal or hepatic disease.
Description

Renal insufficiency or thyroid, renal or hepatic disease

Data type

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0040128
UMLS CUI [3]
C0232804
UMLS CUI [4]
C0232741
have a glycosylated hemoglobin a1c (hba1c) greater than or equal to 10% during the screening period.
Description

HbA1C

Data type

boolean

Alias
UMLS CUI [1]
C0202054
have significant anemia.
Description

Anemia

Data type

boolean

Alias
UMLS CUI [1]
C0002871
have a significant or unstable cardiac history such as history of heart attack, unstable angina, or stroke within 6 months of study entry, history of angina that was treated with long- or short-acting nitrates within 90 days of study entry, history of coronary artery bypass graft surgery or cardiac angioplasty within 90 days of study entry, history of abnormal heart rhythms such as sick sinus syndrome or 2nd- or 3rd-degree av block, chronic atrial fibrillation or recurrent atrial tachyarrhythmia, a history of recurrent ventricular tachycardia, or symptomatic bradycardia, a history of sudden cardiac arrest.
Description

significant or unstable cardiac history

Data type

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0002965
UMLS CUI [4]
C0038454
UMLS CUI [5,1]
C0002962
UMLS CUI [5,2]
C0017887
UMLS CUI [6]
C0010055
UMLS CUI [7]
C0190211
UMLS CUI [8]
C0003811
UMLS CUI [9]
C0037052
UMLS CUI [10]
C0004245
UMLS CUI [11]
C0694539
UMLS CUI [12,1]
C0080203
UMLS CUI [12,2]
C0018792
UMLS CUI [13]
C1737264
UMLS CUI [14]
C0428977
UMLS CUI [15]
C1720824
have symptomatic heart failure requiring treatment, or significant disease of the heart valves.
Description

symptomatic heart failure or significant disease of the heart valves

Data type

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2]
C0018824
have been treated for severe asthma, bronchospasm, or copd within 3 months of study entry.
Description

Severe asthma, bronchospasm, or copd

Data type

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2]
C0006266
UMLS CUI [3]
C0024117
have severe peripheral vascular disease.
Description

Peripheral vascular disease

Data type

boolean

Alias
UMLS CUI [1]
C0085096
have a documented diagnosis of sleep apnea.
Description

Sleep apnea

Data type

boolean

Alias
UMLS CUI [1]
C0037315
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Similar models

Eligibility Hypertension NCT00157326

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Hypertension
Item
have a documented medical history of hypertension.
boolean
C0020538 (UMLS CUI [1])
Diastolic blood pressure
Item
have cuff seated diastolic blood pressure values greater than or equal to 95 and less than or equal to 104 mm at study entry
boolean
C0428883 (UMLS CUI [1])
Negative serum pregnancy test, contraception
Item
have a negative serum pregnancy test at the time of enrollment and agree to use two medically reliable methods of contraception until study completion, if female is of child-bearing potential, between menarche and 1 year post menopause and not surgically sterilized.
boolean
C0430060 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
Patient Compliance
Item
are able to comply with study procedures and visits
boolean
C1321605 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Resistant hypertension or systolic hypertension
Item
have resistant hypertension or systolic hypertension.
boolean
C0745130 (UMLS CUI [1])
C0221155 (UMLS CUI [2])
Obesity
Item
are obese, defined as having body mass index (bmi) greater than or equal to 35.
boolean
C1305855 (UMLS CUI [1])
Pregnancy or breast feeding
Item
are females who are pregnant or breast feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Renal insufficiency or thyroid, renal or hepatic disease
Item
have a history of severe renal insufficiency or significant thyroid, renal or hepatic disease.
boolean
C1565489 (UMLS CUI [1])
C0040128 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
C0232741 (UMLS CUI [4])
HbA1C
Item
have a glycosylated hemoglobin a1c (hba1c) greater than or equal to 10% during the screening period.
boolean
C0202054 (UMLS CUI [1])
Anemia
Item
have significant anemia.
boolean
C0002871 (UMLS CUI [1])
significant or unstable cardiac history
Item
have a significant or unstable cardiac history such as history of heart attack, unstable angina, or stroke within 6 months of study entry, history of angina that was treated with long- or short-acting nitrates within 90 days of study entry, history of coronary artery bypass graft surgery or cardiac angioplasty within 90 days of study entry, history of abnormal heart rhythms such as sick sinus syndrome or 2nd- or 3rd-degree av block, chronic atrial fibrillation or recurrent atrial tachyarrhythmia, a history of recurrent ventricular tachycardia, or symptomatic bradycardia, a history of sudden cardiac arrest.
boolean
C0018799 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0038454 (UMLS CUI [4])
C0002962 (UMLS CUI [5,1])
C0017887 (UMLS CUI [5,2])
C0010055 (UMLS CUI [6])
C0190211 (UMLS CUI [7])
C0003811 (UMLS CUI [8])
C0037052 (UMLS CUI [9])
C0004245 (UMLS CUI [10])
C0694539 (UMLS CUI [11])
C0080203 (UMLS CUI [12,1])
C0018792 (UMLS CUI [12,2])
C1737264 (UMLS CUI [13])
C0428977 (UMLS CUI [14])
C1720824 (UMLS CUI [15])
symptomatic heart failure or significant disease of the heart valves
Item
have symptomatic heart failure requiring treatment, or significant disease of the heart valves.
boolean
C0018801 (UMLS CUI [1])
C0018824 (UMLS CUI [2])
Severe asthma, bronchospasm, or copd
Item
have been treated for severe asthma, bronchospasm, or copd within 3 months of study entry.
boolean
C0004096 (UMLS CUI [1])
C0006266 (UMLS CUI [2])
C0024117 (UMLS CUI [3])
Peripheral vascular disease
Item
have severe peripheral vascular disease.
boolean
C0085096 (UMLS CUI [1])
Sleep apnea
Item
have a documented diagnosis of sleep apnea.
boolean
C0037315 (UMLS CUI [1])
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