Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Serodus AS
With
Smerud Medical Research International AS
The Research Council of Norway
Age
50–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Mean systolic blood pressure ≥ 150 mmHg and mean diastolic blood pressure \< 90 mmHg - as determined by daytime continuous ambulatory blood pressure measurement (ABPM)
Male or female
Age 50-80 years (both inclusive) at screening
Patients must be on stable doses with one or more antihypertensives
BMI \<32 kg/m2
Written informed consent
You may not be if
Acute myocardial infarction in the last 6 months before screening
Stroke in the last 6 months before screening
Uncompensated heart failure (NYHA Class IV)
Angina pectoris with an anticipated need for administration of short-acting nitrates
Known, severe sleep apnoea
Abnormal laboratory values (i.e. \> 2 x upper normal limit) at screening
Subjects working night shifts (11 PM to 7 AM)
Participation in any other clinical trial with an investigational medicinal product or device within 1 month prior to randomisation.
Subjects with upper arm circumference ≤24 cm or ≥ 42 cm.
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
Pregnant or lactating women.
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
Clareo Health | SER100 in Isolated Systolic Hypertension
