Investigational Drug for Resistant Hypertension Available to UH Patients in Clinical Trial
February 26, 2020
Men and women who are taking three different types of anti-hypertension drugs without success are eligible to participate
UH Clinical Update | February 2020
Patients at University Hospitals whose blood pressure remains high and difficult-to-control -- despite taking at least three different types of blood pressure medications -- are participating in the global Phase 3 PRECISION clinical trial of an investigational medicine that may help. Aprocitentan is an investigational drug taken once daily. The aim of this trial, which will ultimately enroll 600 patients from 17 countries, is to see whether aprocitentan lowers blood pressure when added to the standard of care for patients with resistant hypertension. Nephrologist Arash Rashidi, MD, is leading this research at UH.
To date, almost 500 people have received aprocitentan in several Phase 1 studies and one Phase 2 study. All doses of aprocitentan used in the PRECISION study demonstrated acceptable safety and tolerability, with minimal side effects reported.
Who is eligible for the PRECISION trial?
Dr. Rashidi and his team are enrolling men and women over age 18 who have resistant hypertension, defined as mean sitting systolic blood pressure (SiSBP) ≥ 140 mmHg, measured by unattended automated office blood pressure measurement -- despite having a background of antihypertensive medication of at least three different pharmacological classes (including a diuretic) for at least four weeks before the first study screening visit. Beta-blockers are not counted as background antihypertensive medication.
The study consists of four periods:
- a screening period
- a placebo run-in period
- a randomized treatment period
- and a safety follow-up period
During the screening period, the background antihypertensive medication (except beta-blockers) of subjects will be standardized by switching to a fixed combination of a calcium channel blocker, an angiotensin receptor blocker and a diuretic. Beta-blockers are not counted as background antihypertensive medication. This placebo run-in, single-blind period lasts for four weeks, during which placebo will be added to the standardized background antihypertensive therapy in all subjects. The purpose of this period is to confirm that blood pressure remains uncontrolled despite administration of a placebo.
The randomized treatment period lasts for 48 weeks. In the first double-blind part of four weeks, subjects will be randomized to aprocitentan 25 mg, aprocitentan 12.5 mg or placebo in a 1:1:1 ratio. In the second single-blind part of 32 weeks, all subjects will receive aprocitentan 25 mg. In the third double-blind withdrawal part of 12 weeks, subjects will be re-randomized to aprocitentan 25 mg or placebo in a 1:1 ratio.
The end-of-treatment visit will take place at week 48 or earlier in the event of premature discontinuation of study treatment. The safety follow-up period starts on the day after the last dose of study treatment and ends at least 30 days later.
If you have a patient who could benefit from this clinical trial, please call the UH Nephrology Research office at 216-844-5396.