Systolic Pressure mean | Diastolic blood pressure mean
Item
mean systolic blood pressure ≥ 150 mmhg and mean diastolic blood pressure < 90 mmhg -
boolean
C0871470 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C0428883 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Ambulatory Blood Pressure Monitoring Daytime
Item
as determined by daytime continuous ambulatory blood pressure measurement (abpm)
boolean
C0242876 (UMLS CUI [1,1])
C0332169 (UMLS CUI [1,2])
Gender
Item
male or female
boolean
C0079399 (UMLS CUI [1])
Age
Item
age 50-80 years (both inclusive) at screening
boolean
C0001779 (UMLS CUI [1])
Antihypertensive Agents Quantity Dose Stable
Item
patients must be on stable doses with one or more antihypertensives
boolean
C0003364 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0205360 (UMLS CUI [1,4])
Body mass index
Item
bmi <32 kg/m2
boolean
C1305855 (UMLS CUI [1])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Myocardial Infarction
Item
acute myocardial infarction in the last 6 months before screening
boolean
C0027051 (UMLS CUI [1])
Cerebrovascular accident
Item
stroke in the last 6 months before screening
boolean
C0038454 (UMLS CUI [1])
Heart failure Uncompensated New York Heart Association Classification
Item
uncompensated heart failure (nyha class iv)
boolean
C0018801 (UMLS CUI [1,1])
C0205433 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
Angina Pectoris | Patient need for Nitrates Active short-term
Item
angina pectoris with an anticipated need for administration of short-acting nitrates
boolean
C0002962 (UMLS CUI [1])
C0686904 (UMLS CUI [2,1])
C0028125 (UMLS CUI [2,2])
C0205177 (UMLS CUI [2,3])
C0443303 (UMLS CUI [2,4])
Sleep Apnea Severe
Item
known, severe sleep apnoea
boolean
C0037315 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Laboratory test result abnormal | Raised laboratory findings
Item
abnormal laboratory values (i.e. > 2 x upper normal limit) at screening
boolean
C0438215 (UMLS CUI [1])
C0586721 (UMLS CUI [2])
Night shift worker
Item
subjects working night shifts (11 pm to 7 am)
boolean
C0555008 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
participation in any other clinical trial with an investigational medicinal product or device within 1 month prior to randomisation.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
Upper arm Circumference
Item
subjects with upper arm circumference ≤24 cm or ≥ 42 cm.
boolean
C0446516 (UMLS CUI [1,1])
C0332520 (UMLS CUI [1,2])
Condition Study Subject Participation Status Inappropriate | Condition Interferes with Evaluation | Condition Affecting Patient safety | Condition At risk Poor compliance | Disease Serious | Mental disorders | Physical illness | Collaboration Attitude | Dementia | Substance Use Disorders
Item
any general condition, serious disease or current evidence of any mental or physical disorder or collaboration attitude (e.g. dementia, substance abuse) which, in the judgment of the investigator makes the subject unsuitable for enrollment, and/or may interfere with the study evaluations or affect subject's safety and/or may cause risk for poor protocol compliance
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1261322 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C1113679 (UMLS CUI [3,3])
C0348080 (UMLS CUI [4,1])
C1444641 (UMLS CUI [4,2])
C0032646 (UMLS CUI [4,3])
C0012634 (UMLS CUI [5,1])
C0205404 (UMLS CUI [5,2])
C0004936 (UMLS CUI [6])
C0683323 (UMLS CUI [7])
C0282116 (UMLS CUI [8,1])
C0004271 (UMLS CUI [8,2])
C0497327 (UMLS CUI [9])
C0038586 (UMLS CUI [10])
Pregnancy | Breast Feeding
Item
pregnant or lactating women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Unwilling | Gender Partner Contraceptive methods Unwilling | Exception Postmenopausal state | Exception Female Sterilization
Item
female subjects of childbearing potential, or male subjects whose female partner (unless post-menopausal for 1 year or surgically sterile) is unwilling to use adequate contraceptive measures throughout the duration of the study
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0682323 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
C0558080 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0232970 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0015787 (UMLS CUI [4,2])