PRECISION

Multi-center, blinded, randomized, PaRallEl-group, Phase 3 study with aproCItentan in Subjects with ResIstant HypertensiON

CURRENTLY RECRUITING

Background

Hypertension affects about 6 million people in Australia and is a major risk factor for heart attack and stroke. It is well established that lowering blood pressure (BP) reduces risk of cardiovascular events and early death. Whilst there are a number of different types of antihypertensive medication effective in reducing blood pressure, there are some people whose BP is still uncontrolled. This difficult to control high blood pressure, also called resistant hypertension (RHT), is defined as high blood pressure that remains high despite using, at once, three or more blood pressure medications belonging to different drug classes.

PRECISION is an international, double-blinded, placebo-controlled, randomized, study to examine the blood pressure lowering effect of aprocitentan (a new drug) when added to standard-of-care in resistant hypertension patients and to see if blood pressure reduction is kept for an extend time. Aprocitentan is a drug that blocks the effects of a hormone, endothelin. Endothelin constricts blood vessels and raises blood pressure and has a number of other actions that indirectly affect heart function and may contribute to high blood pressure.

Recruitment for this study will finish in late 2020 and suitable participants for this study will:

  1. have documented medical records of uncontrolled BP despite at least 3 background antihypertensive medications within 1 year prior to screening visit
  2. been treated with at least 3 antihypertensive therapies of different pharmacological classes including a diuretic for at least 4 weeks before the screening visit

A diagnosis of true RHT is made prior to participants being randomised to the study. Any other cause of apparent RHT, such as white coat effect, poor medication adherence, or inadequate dose of antihypertensive medications, need to be ruled out. Secondary causes of hypertension are also investigated (e.g., renovascular disease, hyperaldosteronism, pheochromocytoma, and thyroid disease).

For further information contact med.precision@monash.edu or call the study centre on 1800 199 108.

Study Sponsors

Idorsia Pharmaceuticals Ltd. and Janssen Biotech, Inc.

Trial Registration

NCT03541174