Essential Hypertension | Pharmaceutical Preparations | Washout Period
Item
newly diagnosed as essential hypertension or not treated in the past 2 weeks(if the subject took medication in the past 2 weeks, a wash-out period of at least 2 weeks will be completed prior to performing screening (week -2) assessments)
boolean
C0085580 (UMLS CUI [1])
C0013227 (UMLS CUI [2])
C1710661 (UMLS CUI [3])
Systolic Pressure mean | Mercury sphygmomanometer
Item
mean seated sbp at screen visit = 130mmhg (as measured by a mercury sphygmomanometer)
boolean
C0871470 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C0183432 (UMLS CUI [2])
Diabetes Mellitus, Non-Insulin-Dependent | Glycosylated hemoglobin A
Item
type 2 diabetes (american diabetes association criteria 2004) and hba1c <11%
boolean
C0011860 (UMLS CUI [1])
C0019018 (UMLS CUI [2])
Childbearing Potential Contraceptive methods | Investigational New Drugs
Item
agree to practice acceptable contraceptive measures during the study, and for 30 days after the last dose of study medication is taken if the subject a female of child-bearing potential
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0013230 (UMLS CUI [2])
Informed consent
Item
provide written informed consent
boolean
C0021430 (UMLS CUI [1])
Systolic Pressure mean
Item
mean seated sbp of > 180 mmhg
boolean
C0871470 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
Secondary hypertension
Item
known or suspected secondary hypertension
boolean
C0155616 (UMLS CUI [1])
Anemia | Hemoglobin concentration result
Item
anemia defined by haemoglobin concentration < 10.0 g/dl
boolean
C0002871 (UMLS CUI [1])
C0019029 (UMLS CUI [2])
Hemoglobinopathy | Peripheral Vascular Disease
Item
hemoglobinopathy or peripheral vascular disease
boolean
C0019045 (UMLS CUI [1])
C0085096 (UMLS CUI [2])
Kidney Disease Clinical Significance | Liver disease Clinical Significance | Creatinine measurement, serum | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Bilirubin, total measurement | Alkaline phosphatase measurement
Item
clinically significant renal or hepatic disease (i.e., subjects with serum creatinine = 2.0 mg/dl; alanine aminotransferase, aspartate aminotransferase, total bilirubin, or alkaline phosphatase > 2.5 times the upper limit of the normal reference range)
boolean
C0022658 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0023895 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
C0201976 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0201899 (UMLS CUI [5])
C0201913 (UMLS CUI [6])
C0201850 (UMLS CUI [7])
Angina, Unstable | Angina Pectoris Severe | Coronary artery insufficiency | Congestive heart failure Requirement Pharmacotherapy
Item
unstable or severe angina, coronary insufficiency, or any congestive heart failure requiring pharmacologic treatment
boolean
C0002965 (UMLS CUI [1])
C0002962 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0542052 (UMLS CUI [3])
C0018802 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0013216 (UMLS CUI [4,3])
Chronic disease Requirement Therapeutic procedure Intermittent | Chronic disease Requirement Therapeutic procedure chronic | Adrenal Cortex Hormones Oral | Adrenal Cortex Hormones Intravenous | Intraarticular Corticosteroid Therapy | Topical corticosteroids | inhaled steroids | Adrenal Cortex Hormones Nasal
Item
chronic disease requiring intermittent or chronic treatment with oral, intravenous, or intra-articular corticosteroids (i.e. only use of topical, inhaled or nasal corticosteroids is permissible)
boolean
C0008679 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0205267 (UMLS CUI [1,4])
C0008679 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C0205191 (UMLS CUI [2,4])
C0001617 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C0001617 (UMLS CUI [4,1])
C1522726 (UMLS CUI [4,2])
C4054701 (UMLS CUI [5])
C0304604 (UMLS CUI [6])
C2065041 (UMLS CUI [7])
C0001617 (UMLS CUI [8,1])
C1522019 (UMLS CUI [8,2])
Breast Feeding | Pregnancy | Pregnancy, Planned
Item
female who is lactating, pregnant, or planning to become pregnant
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Abnormality Clinically Significant Indicator Study Subject Participation Status Limited | Physical Examination | Laboratory Procedures | Electrocardiography
Item
clinically significant abnormality identified at screening which in the judgement of the investigator makes the subject unsuitable for inclusion in the study (e.g. physical examination, laboratory tests, or electrocardiogram etc.)
boolean
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0439801 (UMLS CUI [1,4])
C0031809 (UMLS CUI [2])
C0022885 (UMLS CUI [3])
C1623258 (UMLS CUI [4])
Metabolic acidosis | Chronic metabolic acidosis | Diabetic Ketoacidosis
Item
acute or chronic metabolic acidosis or a history of diabetic ketoacidosis
boolean
C0220981 (UMLS CUI [1])
C0740749 (UMLS CUI [2])
C0011880 (UMLS CUI [3])