NCT04277884

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
515

participants targeted

Target at P50-P75 for phase_3 hypertension

Timeline
Completed

Started Jun 2020

Typical duration for phase_3 hypertension

Geographic Reach
6 countries

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 20, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

June 25, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2022

Completed
Last Updated

October 20, 2022

Status Verified

October 1, 2022

Enrollment Period

2.2 years

First QC Date

February 17, 2020

Last Update Submit

October 18, 2022

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Systolic Blood Pressure at office (mmHg)

    Automatic Office Blood Pressure measurement

    From Day 1 to Day 84

Secondary Outcomes (3)

  • Diastolic Blood Pressure at office (mmHg)

    From Day 1 to Day 84

  • Mean 24-hour ambulatory Systolic Blood Pressure (mmHg)

    From Day 1 to Day 84

  • Mean 24-hour ambulatory Diastolic Blood Pressure (mmHg)

    From Day 1 to Day 84

Study Arms (2)

Firibastat

EXPERIMENTAL

Capsules

Drug: Firibastat

Placebo

PLACEBO COMPARATOR

Matching capsules

Drug: Placebo

Interventions

FiribastatDRUG

Oral administration 2×250 mg capsules bid

Also known as: QGC001
Firibastat
PlaceboDRUG

Oral administration 2 capsules bid

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women ≥18 years of age at Screening
  • Diagnosis of primary HTN for at least 6 months prior to Screening

You may not qualify if:

  • Known or suspected secondary HTN (eg, hyperaldosteronism, renovascular HTN, pheochromocytoma, Cushing's disease).
  • Known hypertensive retinopathy (Keith-Wagener Grade 3 or Grade 4) and/or hypertensive encephalopathy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Central Alabama Research

Birmingham, Alabama, 35209-8401, United States

Location

Marvel Clinical Research

Huntington Beach, California, 92647, United States

Location

Orange County Research Center

Tustin, California, 92780, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

Progressive Medical Research

Port Orange, Florida, 32127, United States

Location

Cardiovascular Center of Sarasota

Sarasota, Florida, 34239, United States

Location

Apex Medical Research

Chicago, Illinois, 60607, United States

Location

Cedar Crosse Research Center

Chicago, Illinois, 60607, United States

Location

ClinEdge - Chear Center

The Bronx, New York, 10455, United States

Location

Sterling Research Group - Cincinnati / Mount Auburn

Cincinnati, Ohio, 45219, United States

Location

Insearch - Punzi Medical Center

Carrollton, Texas, 75006, United States

Location

ClinEdge - Dayton Clinical Research

Dayton, Texas, 45406-5144, United States

Location

Juno Research - Corporate Office

Houston, Texas, 77040, United States

Location

Insearch - R&H Clinical Research

Katy, Texas, 77450, United States

Location

Manassas Clinical Research Center

Manassas, Virginia, 20110, United States

Location

Fakultní nemocnice v Motole

Prague, 15006, Czechia

Location

Les Hôpitaux Universitaires de Strasbourg

Strasbourg, Grand Est, 67091, France

Location

Universitätsklinikum Schleswig-Holstein - Campus Kiel

Kiel, 24105, Germany

Location

Ambulatorium Barbara Bazela

Elblag, Żuławy, 82300, Poland

Location

Hospital Universitario de La Princesa

Madrid, 280006, Spain

Location

Related Publications (1)

  • 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.

    PMID: 33027067DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

firibastat

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • George Bakris, MD

    AHA Comprehensive Hypertension Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2020

First Posted

February 20, 2020

Study Start

June 25, 2020

Primary Completion

August 30, 2022

Study Completion

September 20, 2022

Last Updated

October 20, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)DE(1)US(15)FR(1)PL(1)ES(1)