This phase 3 trial will investigate the effects of aprocitentan for the treatment of resistant (difficult to control hypertension. The main outcome to be measured will be change in systolic blood pressure (SBP; the first number in the reading).
The details
Hypertension or high blood pressure is a common condition. To reduce BP, patients can take medication. These drugs are called anti-hypertensives (AHs). There are many different types of AHs. Patients may take a combination of different AHs to manage BP levels. Some patients do not respond to AH treatment. This type of hypertension is called resistant hypertension (RHT). New drugs are needed to treat RHT. Aprocitentan is an experimental drug that blocks the endothelin receptor on blood vessels. This leads to relaxation of the muscle and reduces BP. Aprocitentan is a by-product of macitentan (Opsumit®).
This trial will investigate the effects of aprocitentan for the treatment of resistant hypertension. The main outcome will be a change in systolic blood pressure (SBP).
Who are they looking for?
This trial will recruit 600 participants. Participants must have been treated with at least 3 different types of anti-hypertensive drugs for a minimum of 4 weeks before enrolling in the trial. SBP should be higher than 140 mmHg. Women that are pregnant or breastfeeding cannot take part in the trial. These patients should agree to use contraception during the trial and up to 30 days after the trial.
People with severe hypertension (greater than 180/110 mm Hg) cannot take part in the trial. Patients with unstable heart disease, severe kidney disease or any pre-existing disease that may affect the results will not be recruited.
How will it work
There are 3 parts to this trial. Prior to the trial, participants will switch to a standardized background medication for a minimum of 4 weeks. During the first part, participants will be called to one of 3 groups. Group 1 will receive12.5 mg aprocitentan, group 2 will take 25 mg aprocitentan and group 3 will take a placebo. This treatment will last 4 weeks. In the second part, all participants will switch to 25 mg aprocitentan for 32 weeks. In the third part, participants will be randomly re-assigned to either 25 mg aprocitentan or placebo for 4 weeks. The trial lasts a total of 40 weeks.
The main outcome will be a change in systolic blood pressure after 4 weeks of treatment.
