Firibastat in Treatment-resistant Hypertension

Last updated: October 18, 2022
Sponsor: Quantum Genomics SA
Overall Status: Completed

Phase

3

Condition

Circulation Disorders

Stress

Vascular Diseases

Treatment

N/A

Clinical Study ID

NCT04277884
QGC001-3QG1
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 hypertensiveencephalopathy.

Study Design

Total Participants: 515
Study Start date:
June 25, 2020
Estimated Completion Date:
September 20, 2022

Study 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.

Connect with a study center

  • Fakultní nemocnice v Motole

    Prague, 15006
    Czechia

    Site Not Available

  • Les Hôpitaux Universitaires de Strasbourg

    Strasbourg, Grand Est 67091
    France

    Site Not Available

  • Universitätsklinikum Schleswig-Holstein - Campus Kiel

    Kiel, 24105
    Germany

    Site Not Available

  • Ambulatorium Barbara Bazela

    Elbląg, Żuławy 82300
    Poland

    Site Not Available

  • Hospital Universitario de La Princesa

    Madrid, 280006
    Spain

    Site Not Available

  • Central Alabama Research

    Birmingham, Alabama 35209-8401
    United States

    Site Not Available

  • Marvel Clinical Research

    Huntington Beach, California 92647
    United States

    Site Not Available

  • Orange County Research Center

    Tustin, California 92780
    United States

    Site Not Available

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • Progressive Medical Research

    Port Orange, Florida 32127
    United States

    Site Not Available

  • Cardiovascular Center of Sarasota

    Sarasota, Florida 34239
    United States

    Site Not Available

  • Apex Medical Research

    Chicago, Illinois 60607
    United States

    Site Not Available

  • Cedar Crosse Research Center

    Chicago, Illinois 60607
    United States

    Site Not Available

  • ClinEdge - Chear Center

    Bronx, New York 10455
    United States

    Site Not Available

  • Sterling Research Group - Cincinnati / Mount Auburn

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Insearch - Punzi Medical Center

    Carrollton, Texas 75006
    United States

    Site Not Available

  • ClinEdge - Dayton Clinical Research

    Dayton, Texas 45406-5144
    United States

    Site Not Available

  • Juno Research - Corporate Office

    Houston, Texas 77040
    United States

    Site Not Available

  • Insearch - R&H Clinical Research

    Katy, Texas 77450
    United States

    Site Not Available

  • Manassas Clinical Research Center

    Manassas, Virginia 20110
    United States

    Site Not Available

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