Randomized Study of Extended Treatment With Firibastat in Treatment-Resistant Hypertension (REFRESH)
Status:
Recruiting
Trial end date:
2024-07-21
Target enrollment:
Participant gender:
Summary
This is a double-blind, placebo-controlled and open-label, multicenter efficacy and long-term
safety study of firibastat (QGC001) 1000 mg (2×500 mg tablets) administered po, QD, for up to
48 weeks in patients with difficult-to-treat/treatment-resistant HTN. Subjects will continue
to take their chronic antihypertensive therapies (at least 2 classes of antihypertensive
therapies) at the MTDs during the Run in Period and for the duration of the study. For
treatment-resistant subjects, one of the antihypertensive therapies must be a diuretic; for
difficult-to-treat subjects, the antihypertensive therapies do not have to include a
diuretic. Subjects will complete subject medication diaries during the Run-in Period. If
systolic automated office BP (AOBP) is ≥180 mmHg or diastolic BP (DBP) ≥110 mmHg at any visit
during the study (and repeated and confirmed within 30 min), the subject will be withdrawn
from the study and will receive appropriate treatment.