Firibastat in Treatment-resistant Hypertension (FRESH)

Quantum Genomics

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: Placebo; Drug: Firibastat

Study type: Interventional

Funder types: Industry

Identifiers

NCT04277884

QGC001-3QG1

Details and patient eligibility

About

This is a double-blind, placebo-controlled, multicenter, efficacy and safety study of firibastat (QGC001) administered po bid over 12 weeks in male and female subjects ≥18 years of age at Screening, with uncontrolled primary HTN. Subjects will be randomized 1:1 to investigational product (IP) and will receive either firibastat (QGC001) or matching placebo on top of their current chronic antihypertensive treatments.

Full description

The primary objective of this study is to assess the effects of administration of firibastat (QGC001) 500 mg oral (po) twice daily (bis in die [bid]) on blood pressure (BP) over 12 weeks in subjects with uncontrolled primary HTN.

Enrollment: 515 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women ≥18 years of age at Screening
• Diagnosis of primary HTN for at least 6 months prior to Screening

Exclusion criteria

• Known or suspected secondary HTN (eg, hyperaldosteronism, renovascular HTN, pheochromocytoma, Cushing's disease).
• Automated office SBP >180 mmHg or DBP >110 mmHg at the Screening or Inclusion Visit (Visit 2, Day 1) and confirmed by a second measurement within 30 minutes to 1 hour.
• Known hypertensive retinopathy (Keith-Wagener Grade 3 or Grade 4) and/or hypertensive encephalopathy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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515 participants in 2 patient groups, including a placebo group

Firibastat

Experimental group

Description:

Capsules

Treatment:

Drug: Firibastat

Placebo

Placebo Comparator group

Description:

Matching capsules

Treatment:

Drug: Placebo