Trial intelligence / Profile preview

Firibastat in difficult-to-treat/resistant hypertension (REFRESH)

NCT04857840Phase 3

Key facts

Status
Terminated
Start
Aug 2021
Primary completion
Jan 2023
Countries
2
Modality
Prodrugs/Conditional Activator Small Molecules
Conditions
hypertension (HTN)
01

Overview

Phase 3, randomised, double-blind trial in hypertension (HTN) comparing Firibastat Group with Placebo Group (2 arms). Primary endpoint: Change from baseline in systolic Automated Office Blood Pressure at 12 weeks. Started Aug 2021; status: terminated.

02

Design

2 arms
Study design
RandomizedDouble-blind
  • Firibastat Group

    Firibastat 1000mg QD (Period 1, 2, 3)

  • Placebo Group

    Placebo QD (Period 1) -> Firibastat 1000mg QD (Period 2, 3)

03

Who it enrols

Adults with primary hypertension treated with 2-3 antihypertensive classes (including a diuretic for resistant HTN) who have uncontrolled BP (AOBP 140-179 mmHg) and successful ABPM. Excludes secondary HTN, severe renal/hepatic impairment, unstable cardiac history, and type 1 diabetes.

04

Endpoints

Primary

  • Change from baseline in systolic Automated Office Blood Pressure

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