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Randomized Study of Extended Treatment With Firibastat in Treatment-Resistant Hypertension (REFRESH)

NCT04857840 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 419

Last updated 2023-01-17

No results posted yet for this study

Summary

This is a double-blind, placebo-controlled and open-label, multicenter efficacy and long-term safety study of firibastat (QGC001) 1000 mg (2×500 mg tablets) administered po, QD, for up to 48 weeks in patients with difficult-to-treat/treatment-resistant HTN. Subjects will continue to take their chronic antihypertensive therapies (at least 2 classes of antihypertensive therapies) at the MTDs during the Run in Period and for the duration of the study. For treatment-resistant subjects, one of the antihypertensive therapies must be a diuretic; for difficult-to-treat subjects, the antihypertensive therapies do not have to include a diuretic. Subjects will complete subject medication diaries during the Run-in Period. If systolic automated office BP (AOBP) is ≥180 mmHg or diastolic BP (DBP) ≥110 mmHg at any visit during the study (and repeated and confirmed within 30 min), the subject will be withdrawn from the study and will receive appropriate treatment.

Conditions

  • Hypertension (HTN)

Interventions

DRUG

Firibastat (QGC001) Period 1

1000 mg (2 x 500 mg) tablets QD per Os

Sponsors & Collaborators

  • PRA Health Sciences

    collaborator INDUSTRY

  • Quantum Genomics SA

    lead INDUSTRY

Principal Investigators

  • Georges GB BAKRIS, MD · AHA Comprehensive Hypertension Center University of Chicago Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-05
Primary Completion
2023-01-09
Completion
2023-01-09
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

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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 NCT04857840 on ClinicalTrials.gov