Age
Item
1. both sexes. eighteen years or older and no more than 70 years at the time of informed consent
boolean
C0001779 (UMLS CUI [1])
Essential Hypertension CTCAE Grades
Item
2. grade i or ii essential hypertension
boolean
C0085580 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Sitting systolic blood pressure Criteria Fulfill | Sitting diastolic blood pressure Criteria Fulfill
Item
3. both sitting systolic and diastolic blood pressures at week 0 during the run-in period meet the following criteria:
boolean
C1319893 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
C1319894 (UMLS CUI [2,1])
C0243161 (UMLS CUI [2,2])
C1550543 (UMLS CUI [2,3])
Sitting systolic blood pressure
Item
sitting systolic blood pressure: greater than or equal to 150 mmhg and less than 180 mmhg
boolean
C1319893 (UMLS CUI [1])
Sitting diastolic blood pressure
Item
sitting diastolic blood pressure: greater than or equal to 95 mmhg and less than 110 mmhg
boolean
C1319894 (UMLS CUI [1])
Comprehension Study Protocol | Protocol Compliance | Informed Consent
Item
4. able to understand the content of the study and comply with the study and to give informed consent in writing before participating in the study
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
C0021430 (UMLS CUI [3])
Secondary hypertension | Hypertensive disease CTCAE Grades | Sitting systolic blood pressure | Sitting diastolic blood pressure | Malignant Hypertension | Hypertensive emergency | Hypertensive urgency
Item
1. secondary hypertension, grade iii hypertension (sitting systolic blood pressure greater than or equal to 180 mmhg or sitting diastolic blood pressure greater than or equal to 110 mmhg), or malignant hypertension,hypertensive emergencies,hypertensive urgencies
boolean
C0155616 (UMLS CUI [1])
C0020538 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
C1319893 (UMLS CUI [3])
C1319894 (UMLS CUI [4])
C0020540 (UMLS CUI [5])
C0745136 (UMLS CUI [6])
C0745138 (UMLS CUI [7])
Disorder of circulatory system | Symptoms circulatory system
Item
2. the following circulatory-related diseases or symptoms:
boolean
C0728936 (UMLS CUI [1])
C0476270 (UMLS CUI [2])
Heart Disease | Angina Pectoris | Valvular stenosis | Atrial Fibrillation | Disease Requirement Pharmaceutical Preparations | Congestive heart failure | Cardiac Arrhythmia | Cerebrovascular Disorders | Cerebral Infarction | Cerebral Hemorrhage | Transient Ischemic Attack | Vascular Diseases | Arteriosclerosis Obliterans | Symptoms Intermittent Claudication | Hypertensive Retinopathy Progressive | Hemorrhage | Exudation | Papilledema
Item
(1) cardiac disease: angina pectoris; valvular stenosis; atrial fibrillation; the following diseases requiring medication: congestive heart failure or arrhythmia; (2) cerebrovascular disorder: cerebral infarction, cerebral hemorrhage (onset within 24 weeks before start of the screening period), transient ischemic attack (onset of an attack within 24 weeks before start of the screening period); (3) vascular disease: arteriosclerosis obliterans with symptoms of intermittent claudication; (4) progressive hypertensive retinopathy: hemorrhage, exudation, or papilledema (observed within 24 weeks after start of the screening period)
boolean
C0018799 (UMLS CUI [1])
C0002962 (UMLS CUI [2])
C1883524 (UMLS CUI [3])
C0004238 (UMLS CUI [4])
C0012634 (UMLS CUI [5,1])
C1514873 (UMLS CUI [5,2])
C0013227 (UMLS CUI [5,3])
C0018802 (UMLS CUI [6])
C0003811 (UMLS CUI [7])
C0007820 (UMLS CUI [8])
C0007785 (UMLS CUI [9])
C2937358 (UMLS CUI [10])
C0007787 (UMLS CUI [11])
C0042373 (UMLS CUI [12])
C0003851 (UMLS CUI [13])
C1457887 (UMLS CUI [14,1])
C0021775 (UMLS CUI [14,2])
C0152132 (UMLS CUI [15,1])
C0205329 (UMLS CUI [15,2])
C0019080 (UMLS CUI [16])
C0311437 (UMLS CUI [17])
C0030353 (UMLS CUI [18])
Sitting diastolic blood pressure Decreased
Item
3. decrease in sitting diastolic blood pressure by 8 mmhg or more at the end of the run-in period (week 0) compared to the start of the screening period
boolean
C1319894 (UMLS CUI [1,1])
C0392756 (UMLS CUI [1,2])
Night shift worker
Item
4. day/night reversal, e.g., nightshift worker
boolean
C0555008 (UMLS CUI [1])
Unilateral renal artery stenosis | Bilateral renal artery stenosis
Item
5. unilateral or bilateral renal artery stenosis
boolean
C0856759 (UMLS CUI [1])
C0856760 (UMLS CUI [2])
Hepatic impairment | Renal Insufficiency | Aspartate aminotransferase increased | Alanine aminotransferase increased | Serum creatinine raised
Item
6. clinically apparent hepatic and renal impairment (e.g., with ast and alt values of 2.5 x upper limit of normal or higher, with serum creatinine value of 1.5 x upper limit of normal or higher during the screening period)
boolean
C0948807 (UMLS CUI [1])
C1565489 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0151905 (UMLS CUI [4])
C0700225 (UMLS CUI [5])
Hyperkalemia | Laboratory Results
Item
7. hyperkalemia (with a laboratory value of 5.5 meq/l or higher during the run-in period)
boolean
C0020461 (UMLS CUI [1])
C1254595 (UMLS CUI [2])
Malignant Neoplasms
Item
8. malignant tumor
boolean
C0006826 (UMLS CUI [1])
Compliance behavior Percentage Investigational New Drugs
Item
9. compliance with the study drug of less than 80% during the run-in period
boolean
C1321605 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
Poorly controlled diabetes mellitus | Plasma fasting glucose measurement | Complications | Kidney Disease | Peripheral Neuropathy
Item
10. poorly-controlled diabetes mellitus (fasting plasma glucose greater than 11mmol/l),and/or complications (kidney disease, peripheral neuropathy) at screening.
boolean
C0554876 (UMLS CUI [1])
C0583513 (UMLS CUI [2])
C0009566 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C0031117 (UMLS CUI [5])
Hypersensitivity Olmesartan medoxomil | Hypersensitivity Pharmaceutical Preparations Related | Allergy to angiotensin II receptor antagonist | Angiotensin-converting-enzyme inhibitor allergy | Hypersensitivity Renin inhibitor
Item
11. history of hypersensitivity or allergy to olmesartan medoxomil tablets and related drugs (arb, ace inhibitors, and renin inhibitors)
boolean
C0020517 (UMLS CUI [1,1])
C0386393 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
C2585204 (UMLS CUI [3])
C0571939 (UMLS CUI [4])
C0020517 (UMLS CUI [5,1])
C1960108 (UMLS CUI [5,2])
Drug abuse | Illicit medication use | Alcoholic Intoxication, Chronic
Item
12. history of drug abuse (defined as illegal drug use) or alcohol dependency within 2 years before start of the screening period
boolean
C0013146 (UMLS CUI [1])
C0281875 (UMLS CUI [2])
C0001973 (UMLS CUI [3])
Requirement Therapeutic procedure Excluded
Item
13. requirement of the excluded treatment
boolean
C1514873 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
14. pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Study Subject Participation Status
Item
15. participation in another clinical trial or post-marketing clinical trial within 30 days before start of the screening period
boolean
C2348568 (UMLS CUI [1])
Aviation Worker | Driver of motor vehicle
Item
16. dangerous machinery operator such as aerial worker,motor vehicle driver
boolean
C0004430 (UMLS CUI [1,1])
C1306056 (UMLS CUI [1,2])
C0336498 (UMLS CUI [2])