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Vasopeptidase Inhibitor

Firibastat in Treatment-resistant Hypertension (FRESH Trial)

Phase 3
Waitlist Available
Led By George Bakris, MD
Research Sponsored by Quantum Genomics SA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from day 1 to day 84
Awards & highlights
Pivotal Trial

Summary

This trial tests firibastat, a twice-daily pill, in adults with high blood pressure that isn't controlled by their current medications. The goal is to see if firibastat can help lower their blood pressure over a few months. Firibastat has shown efficacy in lowering blood pressure in previous studies.

Eligible Conditions
  • High Blood Pressure

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day 1 to day 84
This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1 to day 84 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Systolic Blood Pressure at office (mmHg)
Secondary study objectives
Diastolic Blood Pressure at office (mmHg)
Mean 24-hour ambulatory Diastolic Blood Pressure (mmHg)
Mean 24-hour ambulatory Systolic Blood Pressure (mmHg)

Side effects data

From 2021 Phase 2 trial • 295 Patients • NCT03715998
4%
Hypotension
3%
COVID-19
3%
Coronary artery disease
3%
Dizziness
3%
rash maculo-papular
2%
Skin exfoliation
2%
Dermatitis Allergic
2%
Orthostatic hypotension
2%
Epistaxis
2%
Hypertension
2%
Myalgia
2%
Cardiac failure
2%
Chest pain
2%
Contusion
2%
Dressler's syndrome
2%
Ecchymosis
1%
Vascular stent trombosis
1%
Dypsnoea
1%
Aortic valve incompetence
1%
Retinal Detachment
1%
Death
1%
COVID19
1%
Ischaemic stroke
1%
Ventricule rupture
1%
Chest pain or chest discomfort (non cardiac)
1%
Cough
1%
Periprocedural myocadial infarction
1%
Cardiac tamponade
1%
Myocardial Infarction
1%
Diarrhea
1%
Hyperkalemia
1%
Liver disorder
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 1: Firibastat 100 mg
Group 2: Firibastat 500 mg
Group 3: Ramipril 5 mg

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: FiribastatExperimental Treatment1 Intervention
Capsules
Group II: PlaceboPlacebo Group1 Intervention
Matching capsules
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
QGC-001
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Quantum Genomics SALead Sponsor
9 Previous Clinical Trials
1,192 Total Patients Enrolled
George Bakris, MDPrincipal InvestigatorAHA Comprehensive Hypertension Center
6 Previous Clinical Trials
878 Total Patients Enrolled
~95 spots leftby Dec 2025
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