Essential Hypertension | Diastolic blood pressure | Diabetes Mellitus | Chronic Kidney Disease
Item
1. has essential hypertension (diastolic blood pressure ≥ 95mm hg and ≤ 119 mm hg. for participants with diabetes or chronic kidney disease diastolic blood pressure must be
boolean
C0085580 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
C0011849 (UMLS CUI [3])
C1561643 (UMLS CUI [4])
Diastolic blood pressure
Item
≥ 85 mm hg and ≤ to 109 mm hg.
boolean
C0428883 (UMLS CUI [1])
Gender Infertility | Female Sterilization | Postmenopausal state
Item
2. female participant is not of childbearing potential (eg, sterilized, postmenopausal).
boolean
C0079399 (UMLS CUI [1,1])
C0021359 (UMLS CUI [1,2])
C0015787 (UMLS CUI [2])
C0232970 (UMLS CUI [3])
Childbearing Potential Sexually active Contraceptive methods | Pregnancy Absent | Breast Feeding Absent
Item
3. female participants of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from screening throughout the duration of the study.
boolean
C3831118 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
C0032961 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0006147 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Laboratory data interpretation Within Reference Range | Clinical Chemistry Within Reference Range | Hematology Within Reference Range | Urinalysis complete status Within Reference Range
Item
4. clinical laboratory evaluations (including clinical chemistry, hematology, and complete urinalysis) are within the reference range for the testing laboratory unless the results are deemed not clinically significant for inclusion into this study by the investigator.
boolean
C0262707 (UMLS CUI [1,1])
C0332285 (UMLS CUI [1,2])
C0086715 (UMLS CUI [1,3])
C0525044 (UMLS CUI [2,1])
C0332285 (UMLS CUI [2,2])
C0086715 (UMLS CUI [2,3])
C0200627 (UMLS CUI [3,1])
C0332285 (UMLS CUI [3,2])
C0086715 (UMLS CUI [3,3])
C1545793 (UMLS CUI [4,1])
C0332285 (UMLS CUI [4,2])
C0086715 (UMLS CUI [4,3])
Systolic Pressure
Item
1. systolic blood pressure greater than 185 mm hg.
boolean
C0871470 (UMLS CUI [1])
Illicit drug use Interferes with Evaluation Investigational New Drugs | Pharmaceutical Preparations prescribed Interfere with Evaluation Investigational New Drugs | Phytotherapy Interferes with Evaluation Investigational New Drugs | Non-Prescription Drugs Interfere with Evaluation Investigational New Drugs
Item
2. is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
boolean
C0281875 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C1261322 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
C0013227 (UMLS CUI [2,1])
C0278329 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C1261322 (UMLS CUI [2,4])
C0013230 (UMLS CUI [2,5])
C0242388 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C1261322 (UMLS CUI [3,3])
C0013230 (UMLS CUI [3,4])
C0013231 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C1261322 (UMLS CUI [4,3])
C0013230 (UMLS CUI [4,4])
Hypersensitivity Angiotensin II receptor antagonist
Item
3. is hypersensitive to aii receptor blockers.
boolean
C0020517 (UMLS CUI [1,1])
C0521942 (UMLS CUI [1,2])
Myocardial Infarction | Angina, Unstable | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention | Cerebrovascular accident | Transient Ischemic Attack
Item
4. recent history (within the last 6 months) of myocardial infarction, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, cerebrovascular accident, or transient ischemic attack.
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0010055 (UMLS CUI [3])
C1532338 (UMLS CUI [4])
C0038454 (UMLS CUI [5])
C0007787 (UMLS CUI [6])
Heart failure Moderate | Heart failure Severe | Hypertensive Encephalopathy
Item
5. history of moderate to severe heart failure or hypertensive encephalopathy.
boolean
C0018801 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0018801 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0151620 (UMLS CUI [3])
Conduction disorder of the heart | Complete atrioventricular block | Sick Sinus Syndrome
Item
6. has clinically significant cardiac conduction defects (eg, third-degree atrioventricular block, sick sinus syndrome).
boolean
C0264886 (UMLS CUI [1])
C0151517 (UMLS CUI [2])
C0037052 (UMLS CUI [3])
Secondary hypertension Etiology Any
Item
7. has secondary hypertension of any etiology.
boolean
C0155616 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
Unilateral renal artery stenosis | Bilateral renal artery stenosis | Unilateral renal artery stenosis Suspected | Bilateral renal artery stenosis Suspected
Item
8. known or suspected unilateral or bilateral renal artery stenosis.
boolean
C0856759 (UMLS CUI [1])
C0856760 (UMLS CUI [2])
C0856759 (UMLS CUI [3,1])
C0750491 (UMLS CUI [3,2])
C0856760 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
Renal dysfunction Severe | Kidney Disease Severe | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
9. has severe renal dysfunction or disease (based on calculated creatinine clearance < 30 ml/min/1.73 m2) at screening.
boolean
C3279454 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0022658 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C2711451 (UMLS CUI [3])