NCT04277884 (FRESH) is a Phase 3 clinical trial of Firibastat in Hypertension, sponsored by Quantum Genomics SA.

Who is sponsoring NCT04277884?

NCT04277884 is sponsored by Quantum Genomics SA.

What drugs are being tested in NCT04277884?

Interventions in NCT04277884: Firibastat, Placebo.

What condition does NCT04277884 study?

NCT04277884 studies Hypertension.

Is NCT04277884 still recruiting?

NCT04277884 is currently completed. Last updated 20 October 2022.

Last reviewed 2022-10-20 · How we verify

NCT04277884: FRESH

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Firibastat in Treatment-resistant Hypertension

Completed Phase 3 Last updated 20 October 2022

What this trial tests

Phase 3 trial testing Firibastat in Hypertension in 515 participants. Completed in 20 September 2022.

Timeline

25 June 2020

Primary endpoint
30 August 2022

20 September 2022

Quick facts

Lead sponsor	Quantum Genomics SA
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	515
Start date	25 June 2020
Primary completion	30 August 2022
Estimated completion	20 September 2022
Sites	20 locations across France, Germany, Poland, United States, Spain, Czechia

Drugs / interventions tested

Firibastat — full drug profile →
Placebo

Conditions studied

Hypertension — all drugs for Hypertension →

Sponsor

Quantum Genomics SA — full company profile →

Who can join

18 and older, any sex, with Hypertension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

Novel therapeutics for the treatment of hypertension and its associated complications: peptide- and nonpeptide-based strategies.
Ghatage T, Goyal SG, Dhar A, Bhat A. · · 2021 · cited 54× · PMID 33731923 · DOI 10.1038/s41440-021-00643-z
Resistant Hypertension: Disease Burden and Emerging Treatment Options.
Flack JM, Buhnerkempe MG, Moore KT. · · 2024 · cited 25× · PMID 38363454 · DOI 10.1007/s11906-023-01282-0
New Approaches Targeting the Renin-Angiotensin System: Inhibition of Brain Aminopeptidase A, ACE2 Ubiquitination, and Angiotensinogen.
Lazartigues E, Llorens-Cortes C, Danser AHJ. · · 2023 · cited 14× · PMID 37348757 · DOI 10.1016/j.cjca.2023.06.013
The Global Burden of Resistant Hypertension and Potential Treatment Options.
Buso G, Agabiti-Rosei C, Lemoli M, Corvini F, et al · · 2024 · cited 8× · PMID 38983582 · DOI 10.15420/ecr.2023.51
Firibastat, the first-in-class brain aminopeptidase a inhibitor, in the management of hypertension: A review of clinical trials.
Alomar SA, Alghabban SA, Alharbi HA, Almoqati MF, et al · · 2021 · cited 7× · PMID 33520782 · DOI 10.4103/ajm.ajm_117_20
Current Knowledge about the New Drug Firibastat in Arterial Hypertension.
Hansen E, Grimm D, Wehland M. · · 2022 · cited 6× · PMID 35163378 · DOI 10.3390/ijms23031459

Verify or expand the search:

Other trials of Firibastat

Trials testing the same drug.

NCT03715998 — Firibastat or Ramipril After Acute Myocardial Infarction for Prevention of Left Ventricular Dysfunction · Phase 2 · completed
NCT03714685 — Evaluation of the PK Profile of Firibastat Following Administration of Firibastat Prototype Tablet Formulations · Phase 1 · completed

Other recruiting trials for Hypertension

Currently open trials in the same condition.

NCT07413159 — The "Check, Monitor, Control Hypertension" Study is a 24-month Randomized Trial in Houston Targeting African Americans A · NA · recruiting
NCT07361276 — Observational Study That Will Evaluate Treatment Patterns in the Management of Hypertension in the Public Primary Care S · recruiting
NCT07238556 — A Novel Digital Tool Physicians Can Use to Prescribe Exercise to Patients With Cardiovascular Disease Risk Factors · NA · recruiting
NCT07238400 — Cardiac Effects of Mineralocorticoid Receptor Antagonism After Preeclampsia · Phase 2 · recruiting
NCT07135505 — Early Time-Restricted Eating in Older Adults With Hypertension · NA · recruiting

Other Quantum Genomics SA trials

Trials by the same sponsor.

NCT04857840 — Randomized Study of Extended Treatment With Firibastat in Treatment-Resistant Hypertension (REFRESH) · Phase 3 · terminated
NCT04792333 — Pharmacokinetics in End Stage Renal Disease Patients · Phase 1 · completed
NCT03715998 — Firibastat or Ramipril After Acute Myocardial Infarction for Prevention of Left Ventricular Dysfunction · Phase 2 · completed
NCT03714685 — Evaluation of the PK Profile of Firibastat Following Administration of Firibastat Prototype Tablet Formulations · Phase 1 · completed
NCT03198793 — Novel Evaluation With QGC001 in Hypertensive Overweight Patients of Multiple Ethnic Origins · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04277884 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Quantum Genomics SA
Last refreshed: 20 October 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04277884.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing