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Firibastat in Treatment-resistant Hypertension

NCT04277884 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 515

Last updated 2022-10-20

No results posted yet for this 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.

Conditions

Interventions

DRUG

Firibastat

Oral administration 2×250 mg capsules bid

DRUG

Placebo

Oral administration 2 capsules bid

Sponsors & Collaborators

  • Quantum Genomics SA

    lead INDUSTRY

Principal Investigators

  • George Bakris, MD · AHA Comprehensive Hypertension Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-25
Primary Completion
2022-08-30
Completion
2022-09-20
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • France
  • Germany
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04277884 on ClinicalTrials.gov