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Firibastat in Treatment-resistant Hypertension

NCT ID: NCT04277884

Last Updated: 2022-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

515 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-25

Study Completion Date

2022-09-20

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Firibastat

Capsules

Group Type EXPERIMENTAL

Firibastat

Intervention Type DRUG

Oral administration 2×250 mg capsules bid

Placebo

Matching capsules

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral administration 2 capsules bid

Interventions

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Firibastat

Oral administration 2×250 mg capsules bid

Intervention Type DRUG

Placebo

Oral administration 2 capsules bid

Intervention Type DRUG

Other Intervention Names

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QGC001

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Quantum Genomics SA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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George Bakris, MD

Role: PRINCIPAL_INVESTIGATOR

AHA Comprehensive Hypertension Center

Locations

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Central Alabama Research

Birmingham, Alabama, United States

Site Status

Marvel Clinical Research

Huntington Beach, California, United States

Site Status

Orange County Research Center

Tustin, California, United States

Site Status

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

Site Status

Progressive Medical Research

Port Orange, Florida, United States

Site Status

Cardiovascular Center of Sarasota

Sarasota, Florida, United States

Site Status

Apex Medical Research

Chicago, Illinois, United States

Site Status

Cedar Crosse Research Center

Chicago, Illinois, United States

Site Status

ClinEdge - Chear Center

The Bronx, New York, United States

Site Status

Sterling Research Group - Cincinnati / Mount Auburn

Cincinnati, Ohio, United States

Site Status

Insearch - Punzi Medical Center

Carrollton, Texas, United States

Site Status

ClinEdge - Dayton Clinical Research

Dayton, Texas, United States

Site Status

Juno Research - Corporate Office

Houston, Texas, United States

Site Status

Insearch - R&H Clinical Research

Katy, Texas, United States

Site Status

Manassas Clinical Research Center

Manassas, Virginia, United States

Site Status

Fakultní nemocnice v Motole

Prague, , Czechia

Site Status

Les Hôpitaux Universitaires de Strasbourg

Strasbourg, Grand Est, France

Site Status

Universitätsklinikum Schleswig-Holstein - Campus Kiel

Kiel, , Germany

Site Status

Ambulatorium Barbara Bazela

Elblag, Żuławy, Poland

Site Status

Hospital Universitario de La Princesa

Madrid, , Spain

Site Status

Countries

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United States Czechia France Germany Poland Spain

References

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Khosla J, Aronow WS, Frishman WH. Firibastat: An Oral First-in-Class Brain Aminopeptidase A Inhibitor for Systemic Hypertension. Cardiol Rev. 2022 Jan-Feb 01;30(1):50-55. doi: 10.1097/CRD.0000000000000360.

Reference Type DERIVED
PMID: 33027067 (View on PubMed)

Other Identifiers

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QGC001-3QG1

Identifier Type: -

Identifier Source: org_study_id

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