Age
Item
males and females aged 18 to 75 years (inclusive) at screening.
boolean
C0001779 (UMLS CUI [1])
Body mass index | Body Weight
Item
body mass index (bmi) between 18 and 35 kg/m2 (inclusive) and body weight at least 50 kg at screening and prior to enrollment.
boolean
C1305855 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
Abnormality Absent 12 lead ECG
Item
12-lead ecg without clinically relevant abnormalities measured at screening.
boolean
C1704258 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,3])
Chemistry test Normal | Hematologic Tests Normal | Coagulation test normal | Viral serologic study Normal | Urinalysis results Normal
Item
clinical chemistry, hematology, coagulation, virus serology, and urinalysis test results not deviating to a clinically relevant extent from the normal range at screening.
boolean
C0201682 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0018941 (UMLS CUI [2,1])
C0205307 (UMLS CUI [2,2])
C1504380 (UMLS CUI [3])
C0201336 (UMLS CUI [4,1])
C0205307 (UMLS CUI [4,2])
C2097148 (UMLS CUI [5,1])
C0205307 (UMLS CUI [5,2])
Informed Consent Language Local
Item
signed informed consent in the local language prior to any study-mandated procedure
boolean
C0021430 (UMLS CUI [1,1])
C0023008 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Systolic Pressure mean
Item
mean sbp > 180 mmhg.
boolean
C0871470 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
Hypertension, severe | Malignant Hypertension | Secondary hypertension
Item
severe, malignant, or secondary hypertension.
boolean
C4013784 (UMLS CUI [1])
C0020540 (UMLS CUI [2])
C0155616 (UMLS CUI [3])
Episode of Hypertensive crisis | Hypertensive emergency
Item
episodes of hypertensive crisis or hypertensive emergency within 6 months prior to enrollment.
boolean
C0332189 (UMLS CUI [1,1])
C0020546 (UMLS CUI [1,2])
C0745136 (UMLS CUI [2])
History of fainting | Collapse Previous | Syncope Previous | Orthostatic Hypotension Previous | Vasovagal Reaction Previous
Item
previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions considered to be of clinical significance.
boolean
C0848811 (UMLS CUI [1])
C0344329 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0039070 (UMLS CUI [3,1])
C0205156 (UMLS CUI [3,2])
C0020651 (UMLS CUI [4,1])
C0205156 (UMLS CUI [4,2])
C1710621 (UMLS CUI [5,1])
C0205156 (UMLS CUI [5,2])
Indication Coronary Artery Disease Severe | Myocardial Infarction | Percutaneous Coronary Intervention | Coronary Artery Bypass Surgery
Item
e6 severe coronary artery disease indicated by myocardial infarction, percutaneous coronary intervention, or coronary artery bypass graft within the last 12 months prior to enrollment.
boolean
C3146298 (UMLS CUI [1,1])
C1956346 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C0027051 (UMLS CUI [2])
C1532338 (UMLS CUI [3])
C0010055 (UMLS CUI [4])
Angina Pectoris
Item
angina pectoris within 6 months prior to enrollment
boolean
C0002962 (UMLS CUI [1])