Firibastat in Treatment-resistant Hypertension (FRESH)

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Firibastat; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 515
• Phase: Phase 3

Contacts and Locations

Study Locations

• Czechia
  • Prague, Czechia, 15006
    • Fakultni nemocnice v Motole
• France
  • Grand Est
    • Strasbourg, Grand Est, France, 67091
      • Les Hôpitaux Universitaires de Strasbourg
• Germany
  • Kiel, Germany, 24105
    • Universitätsklinikum Schleswig-Holstein - Campus Kiel
• Poland
  • Żuławy
    • Elbląg, Żuławy, Poland, 82300
      • Ambulatorium Barbara Bazela
• Spain
  • Madrid, Spain, 280006
    • Hospital Universitario de la Princesa
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209-8401
      • Central Alabama Research
  • California
    • Huntington Beach, California, United States, 92647
      • Marvel Clinical Research
    • Tustin, California, United States, 92780
      • Orange County Research Center
  • Florida
    • Jacksonville, Florida, United States, 32216
      • Jacksonville Center for Clinical Research
    • Port Orange, Florida, United States, 32127
      • Progressive Medical Research
    • Sarasota, Florida, United States, 34239
      • Cardiovascular Center of Sarasota
  • Illinois
    • Chicago, Illinois, United States, 60607
      • Cedar Crosse Research Center
    • Chicago, Illinois, United States, 60607
      • Apex Medical Research
  • New York
    • Bronx, New York, United States, 10455
      • ClinEdge - Chear Center
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Sterling Research Group - Cincinnati / Mount Auburn
  • Texas
    • Carrollton, Texas, United States, 75006
      • Insearch - Punzi Medical Center
    • Dayton, Texas, United States, 45406-5144
      • ClinEdge - Dayton Clinical Research
    • Houston, Texas, United States, 77040
      • Juno Research - Corporate Office
    • Katy, Texas, United States, 77450
      • Insearch - R&H Clinical Research
  • Virginia
    • Manassas, Virginia, United States, 20110
      • Manassas Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Firibastat; Capsules	Drug: Firibastat; Oral administration 2×250 mg capsules bid; Other Names: QGC001
Placebo Comparator: Placebo; Matching capsules	Drug: Placebo; Oral administration 2 capsules bid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic Blood Pressure at office (mmHg)	Automatic Office Blood Pressure measurement	From Day 1 to Day 84

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diastolic Blood Pressure at office (mmHg)	Automatic Office Blood Pressure measurement	From Day 1 to Day 84
Mean 24-hour ambulatory Systolic Blood Pressure (mmHg)	Ambulatory Blood Pressure Monitoring	From Day 1 to Day 84
Mean 24-hour ambulatory Diastolic Blood Pressure (mmHg)	Ambulatory Blood Pressure Monitoring	From Day 1 to Day 84

Collaborators and Investigators

• Sponsor: Quantum Genomics SA
• Investigators: Principal Investigator: George Bakris, MD, AHA Comprehensive Hypertension Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2020
• Primary Completion (Actual): August 30, 2022
• Study Completion (Actual): September 20, 2022

Study Registration Dates

• First Submitted: February 17, 2020
• First Submitted That Met QC Criteria: February 19, 2020
• First Posted (Actual): February 20, 2020

Study Record Updates

• Last Update Posted (Actual): October 20, 2022
• Last Update Submitted That Met QC Criteria: October 18, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Antihypertensive Agents; Firibastat
• Other Study ID Numbers: QGC001-3QG1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No