Date

2022-05-11

Protocol

Protocol changed

Item Changed

Inclusion criteria

Previous Version

At screening visit 1. Adults of age ?18 years (both male and female) 2. Clinic SBP: 150-179 mmHg on 0 blood pressure (BP)-lowering drugs, or 140-170 mmHg on 1 BP-lowering drug, or 130-160 mmHg on 2 BP-lowering drugs, or 120-150 mmHg on 3 BP-lowering drugs. At randomization visit 1. Home seated mean SBP 120-154 mmHg in the week prior to the randomization visit. 2. Adherence of 80-120% to run-in medication. 3. Tolerated run-in medication. 4. Adherence to home BP monitoring schedule: ?3 days in the week before the randomization visit and 1 day per week during the preceding weeks, with ?2 measures in the specified morning and evening time periods on each day.

Next Version

At screening visit 1. Provided signed consent to participate in the trial. 2. Adult of age ?18 years. 3. Clinic attended automated seated mean SBP (average of 3 measurements): a. 140-179 mmHg on 0 BP-lowering drugs, or b. 130-170 mmHg on 1 BP-lowering drug, or c. 120-160 mmHg on 2 BP-lowering drugs, or d. 110-150 mmHg on 3 BP-lowering drugs. Note: A single tablet containing 2 or 3 different BP lowering agents (i.e. a combination medication) is considered as 2 or 3 BP lowering drugs, respectively. At randomization visit 1. Home seated mean SBP 110-154 mmHg in the week prior to the randomization visit. 2. Adherence of 80-120% to run-in medication. 3. Tolerated run-in medication. 4. Adherence to home BP monitoring schedule: iIn the week before randomization, at least 6 measures (e.g. ?2 sets of triplicate measures) including at least 1 morning and 1 evening each with ?2 measures 5. Morning is defined as any measure in the am and evening as any measure in the pm. Morning and evening do not have to be same day. At week 12 (for optional open-label extension Period) 1. Provided signed informed consent. 2. Completed randomized treatment and willing to continue GMRx2-based regimen for up to 12 months