This trial is aiming to assess the effectiveness and safety of a new drug (CIN-107) in patients with treatment-resistant hypertension (rHTN). The main outcome that will be measured is the change in blood pressure over a time-frame of 12-weeks. This trial is being carried out in the United States.
The details
Resistant hypertension (rHTN) is high blood pressure that does not respond to aggressive medical therapy. It is a difficult to treat medical condition. Having uncontrolled high blood pressure can increase a person's risk of developing life-limiting conditions such as heart attack and stroke. CIN-107 is an experimental treatment that lowers the hormone aldosterone responsible for increasing blood pressure.
This trial is evaluating the safety and effectiveness of CIN-107 in patients with rHTN. The main outcome that will be measured is the change in systolic blood pressure (SBP; blood pressure of the heart during contraction of the heart muscle) over the course of 12-weeks.
Who are they looking for?
This trial is looking to recruit 448 patients with rHTN. Patients must be currently on 3 or more blood-pressure-lowering medications.
Patients will be excluded if they have a blood pressure of 180/110mmHg or higher, have been on night-shifts at any time during 4-weeks before the study, and using a beta-blocker for any other medical condition apart from high blood pressure. Participants with heart failure or severe kidney disease, uncontrolled diabetes, HIV, hepatitis, or alcohol addiction will be excluded.
How will it work
There will be 4 different groups in this trial. Groups 1-3 will receive different doses of CIN-107 tablets once a day. Group 4 will receive a placebo drug. Patients will be treated for 12-weeks. Blood-pressure will be measured over the course of the trial.
