Clinical trial NCT04277884: Firibastat in Treatment-resistant Hypertension
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: Quantum Genomics SA
Sponsor class: INDUSTRY
First posted: 2020-02-20
Enrollment: 515
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Systolic Blood Pressure at office (mmHg)
timeFrame: From Day 1 to Day 84
Secondary outcomes:
measure: Diastolic Blood Pressure at office (mmHg)
timeFrame: From Day 1 to Day 84
measure: Mean 24-hour ambulatory Systolic Blood Pressure (mmHg)
timeFrame: From Day 1 to Day 84
measure: Mean 24-hour ambulatory Diastolic Blood Pressure (mmHg)
timeFrame: From Day 1 to Day 84
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Central Alabama Research
state: Alabama
city: Huntington Beach
country: United States
facility: Marvel Clinical Research
state: California
city: Tustin
country: United States
facility: Orange County Research Center
state: California
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: Sarasota
country: United States
facility: Cardiovascular Center of Sarasota
state: Florida
city: Chicago
country: United States
facility: Apex Medical Research
state: Illinois
city: Chicago
country: United States
facility: Cedar Crosse Research Center
state: Illinois
city: Bronx
country: United States
facility: ClinEdge - Chear Center
state: New York
city: Cincinnati
country: United States
facility: Sterling Research Group - Cincinnati / Mount Auburn
state: Ohio
city: Carrollton
country: United States
facility: Insearch - Punzi Medical Center
state: Texas
city: Dayton
country: United States
facility: ClinEdge - Dayton Clinical Research
state: Texas
city: Houston
country: United States
facility: Juno Research - Corporate Office
state: Texas
city: Katy
country: United States
facility: Insearch - R&H Clinical Research
state: Texas
city: Manassas
country: United States
facility: Manassas Clinical Research Center
state: Virginia
city: Prague
country: Czechia
facility: Fakultní nemocnice v Motole
city: Strasbourg
country: France
facility: Les Hôpitaux Universitaires de Strasbourg
state: Grand Est
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein - Campus Kiel
city: Elbląg
country: Poland
facility: Ambulatorium Barbara Bazela
state: Żuławy
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
Study officials:
affiliation: AHA Comprehensive Hypertension Center
name: George Bakris, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.