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ACE inhibitor

Firibastat (QGC001) Period 1 for High Blood Pressure (REFRESH Trial)

Phase 3
Waitlist Available
Research Sponsored by Quantum Genomics SA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

REFRESH Trial Summary

This trial is testing a new drug, firibastat, to see if it is safe and effective in treating hypertension. The trial will last up to 48 weeks and involve taking the drug once a day.

Eligible Conditions
  • High Blood Pressure

REFRESH Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The primary efficacy endpoint is the change from baseline in systolic AOBP at Week 12.

REFRESH Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm A: Investigational Product /Period 1,2 and 3 if any (open label)Experimental Treatment1 Intervention
Firibastat 1000 mg tablets QD - 12 weeks
Group II: Arm B: Placebo/Period1 onlyPlacebo Group1 Intervention
Placebo tablets QD 12 weeks in Period 1 only, followed by open label Period 2 and 3 if any.

Find a Location

Who is running the clinical trial?

Quantum Genomics SALead Sponsor
9 Previous Clinical Trials
1,288 Total Patients Enrolled
PRA Health SciencesIndustry Sponsor
94 Previous Clinical Trials
35,872 Total Patients Enrolled
Georges GB BAKRIS, MDStudy ChairAHA Comprehensive Hypertension Center University of Chicago Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the potential risks associated with taking Firibastat (QGC001) during the first stage of the trial?

"This is a Phase 3 clinical trial, which means that while there is some evidence of efficacy, Firibastat's safety has been corroborated multiple times. Therefore, we give it a score of 3."

Answered by AI

Are there any similar cases to Firibastat (QGC001) in terms of medical research?

"Firibastat (QGC001), which was first studied in 2021, has completed 7 clinical trials. 1 more trial is ongoing, with sites in Manassas, Virginia."

Answered by AI

What makes this clinical trial different from others?

"Firibastat (QGC001) Period 1 was first studied in 2021 by Quantum Genomics SA. The Phase 3 drug approval process was completed in 2021 after the initial trial with 750 patients. As of now, the only live trial for Firibastat (QGC001) Period 1 is being sponsored by Quantum Genomics SA."

Answered by AI

Which patients would best fit the eligibility criteria for this trial?

"This study seeks to enroll 750 participants between the ages of 18 and 99 who have been diagnosed with hypertensive disease. Additionally, potential subjects must meet the following criteria: Understanding of and willingness to provide written informed consent, ability to comply with study procedures and restrictions, successful ABPM measurement with a mean systolic daytime ABP above 135 mmHg after the Run-in Period while taking chronic antihypertensive treatments, adult men and women, currently treated with 2 antihypertensive classes of drug or 3 antihypertensive classes of drug including a diuretic at the MTDs of those medications, with no change"

Answered by AI

Does this experimental treatment include elderly test subjects?

"This trial is enrolling patients that were born no earlier than 18 years ago and no later than 1999."

Answered by AI

Who else is applying?

What state do they live in?
California
West Virginia
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Randomized Study of Extended Treatment With Firibastat in Treatment-Resistant Hypertension (REFRESH)
2021. "Randomized Study of Extended Treatment With Firibastat in Treatment-Resistant Hypertension (REFRESH)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04857840.
~114 spots leftby Apr 2025
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