Table 1.
Treatment phase | ||||||||
---|---|---|---|---|---|---|---|---|
Activity | Screening | Week −2a | Week 0 | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 |
Clinic visit | X | X | X | X | X | |||
Review eligibility | X | X | X | |||||
Informed consent | X | X | X | |||||
Salivary DNA sample | X | |||||||
Demography | X | X | X | |||||
Medical history | X | X | X | |||||
Medical examination | Xc | Xc | Xc | |||||
Weight, height, BMI | X | X | X | X | ||||
Medication review | X | X | X | X | X | |||
Clinic blood pressure | X | X | X | X | X | |||
Blood sampling | X | X | X | X | X | |||
ECG | Xc | Xc | ||||||
Urine sampling | Xb | X | Xb | |||||
ABPM | X | X | X | |||||
HBPM | X | X | X | |||||
Compliance check | X | X | X | |||||
Adverse events reporting | X | X | X | |||||
Dispense study medication | X | X |
Abbreviations: ABPM, ambulatory blood pressure monitoring; BMI, body mass index; ECG, electrocardiogram; HBPM, home blood pressure monitoring.
aIf on diuretics prior to study.
bIncluding pregnancy testing for women of childbearing potential.
cNot required for all participants, at discretion of the investigator.