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Firibastat in Treatment-resistant Hypertension

A Phase 3, Double-blind, Placebo-controlled, Efficacy and Safety Study of Firibastat (QGC001) Administered Orally, Twice Daily, Over 12 Weeks in Difficult-to-treat/Resistant Hypertensive Subjects

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04277884
Acronym
FRESH
Enrollment
515
Registered
2020-02-20
Start date
2020-06-25
Completion date
2022-09-20
Last updated
2022-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Brief summary

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.

Detailed 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.

Interventions

DRUGPlacebo

Oral administration 2 capsules bid

DRUGFiribastat

Oral administration 2×250 mg capsules bid

Sponsors

Quantum Genomics SA
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Systolic Blood Pressure at office (mmHg)From Day 1 to Day 84Automatic Office Blood Pressure measurement

Secondary

MeasureTime frameDescription
Diastolic Blood Pressure at office (mmHg)From Day 1 to Day 84Automatic Office Blood Pressure measurement
Mean 24-hour ambulatory Systolic Blood Pressure (mmHg)From Day 1 to Day 84Ambulatory Blood Pressure Monitoring
Mean 24-hour ambulatory Diastolic Blood Pressure (mmHg)From Day 1 to Day 84Ambulatory Blood Pressure Monitoring

Countries

Czechia, France, Germany, Poland, Spain, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026