ID.1
Item
males or females 30 - 80 years
boolean
C0001779 (UMLS CUI [1])
ID.2
Item
mean seated systolic blood pressure (sbp) ≥ 150 - ≤ 179 mmhg and mean seated dbp < 110 mmhg at two consecutive qualifying visits. the mean difference in sbp between the two consecutive qualifying visits must be ≤ 10 mmhg.
boolean
C0005823 (UMLS CUI [1])
ID.3
Item
mean daytime (8am - 4pm) ambulatory sbp must be between ≥ 140 - ≤ 179 mmhg and mean daytime (8am - 4pm) diastolic blood pressure (dbp) ≤ 110 mmhg
boolean
C0005823 (UMLS CUI [1])
ID.4
Item
subjects must have a usual daytime schedule. night shift workers are excluded from participation.
boolean
ID.5
Item
women of child-bearing potential (wocbp) and male subjects must use two reliable forms of contraception if sexually active. alternatively, female subjects must be postmenopausal (for at least 1 year)
boolean
C0009862 (UMLS CUI [1,1])
C0232970 (UMLS CUI [1,2])
ID.6
Item
subjects with serious disorders which may limit the ability to evaluate the efficacy or safety of ps433540, including cardiovascular, renal (including the absence of one kidney), pulmonary, hepatic, gastrointestinal (including clinically significant malabsorption), endocrine/metabolic, hematologic/oncologic (including an active malignancy other than basal cell carcinoma), neurologic and psychiatric diseases.
boolean
C0012634 (UMLS CUI [1])
ID.7
Item
subjects with a history of myocardial infarction, angina, coronary angioplasty, bypass surgery or new york heart association (nyha) class ii-iv heart failure within the last 6 months.
boolean
C0018799 (UMLS CUI [1])
ID.8
Item
subjects with a history of cerebrovascular accident or transient ischemic attack within the last 1 year.
boolean
C0038454 (UMLS CUI [1,1])
C0007787 (UMLS CUI [1,2])
ID.9
Item
subjects with diabetes mellitus (type i and type ii).
boolean
C0011849 (UMLS CUI [1])