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Completed

NCT Number: NCT04277884

Firibastat in Treatment-resistant Hypertension

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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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fakultní nemocnice v Motole, Prague, Czechia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Firibastat

Drug

Oral administration 2×250 mg capsules bid

Other names: QGC001

Placebo

Drug

Oral administration 2 capsules bid

Primary outcomes

  1. Systolic Blood Pressure at office (mmHg)

    Time frame: From Day 1 to Day 84

    Automatic Office Blood Pressure measurement

Secondary outcomes

  1. Diastolic Blood Pressure at office (mmHg)

    Time frame: From Day 1 to Day 84

    Automatic Office Blood Pressure measurement

  2. Mean 24-hour ambulatory Systolic Blood Pressure (mmHg)

    Time frame: From Day 1 to Day 84

    Ambulatory Blood Pressure Monitoring

  3. Mean 24-hour ambulatory Diastolic Blood Pressure (mmHg)

    Time frame: From Day 1 to Day 84

    Ambulatory Blood Pressure Monitoring

Sponsors and collaborators

Lead sponsor

Quantum Genomics SA

Industry

Registry information

Official study 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

Acronym: FRESH

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 20, 2020
Registry last updated
Oct 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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