Firibastat in Treatment-resistant Hypertension

Quantum Genomics SA515 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

515

Conditions

Hypertension

Interventions

FiribastatDRUG

Oral administration 2×250 mg capsules bid

PlaceboDRUG

Oral administration 2 capsules bid

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (20)

Central Alabama Research

Birmingham, Alabama, United States

Marvel Clinical Research

Outcomes

Primary Outcomes

Systolic Blood Pressure at office (mmHg)

Automatic Office Blood Pressure measurement

Time frame: From Day 1 to Day 84

Secondary Outcomes

Diastolic Blood Pressure at office (mmHg)

Automatic Office Blood Pressure measurement

Time frame: From Day 1 to Day 84

Mean 24-hour ambulatory Systolic Blood Pressure (mmHg)

Ambulatory Blood Pressure Monitoring

Time frame: From Day 1 to Day 84

Mean 24-hour ambulatory Diastolic Blood Pressure (mmHg)

Ambulatory Blood Pressure Monitoring

Time frame: From Day 1 to Day 84

Data from ClinicalTrials.gov

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