HypertensionPhase 3FRESHNCT04277884
Firibastat in Treatment-resistant Hypertension
A Phase 3 study testing Firibastat in people with Hypertension, run by Quantum Genomics SA at 20 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Firibastat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 515 participants
- Where
- 20 sitesin 6 countries
- Study dates
- 25 Jun 2020to 20 Sep 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women ≥18 years of age at Screening
- Diagnosis of primary HTN for at least 6 months prior to Screening
Who cannot join
- 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.
Trial locations and contacts
20 sites in 6 countries.
20 sites in 6 countries
United States15 sites
Central Alabama Research
Birmingham, Alabama, 35209-8401
Insearch - Punzi Medical Center
Carrollton, Texas, 75006
Apex Medical Research
Chicago, Illinois, 60607
Cedar Crosse Research Center
Chicago, Illinois, 60607
Sterling Research Group - Cincinnati / Mount Auburn
Cincinnati, Ohio, 45219
ClinEdge - Dayton Clinical Research
Dayton, Texas, 45406-5144
Juno Research - Corporate Office
Houston, Texas, 77040
Marvel Clinical Research
Huntington Beach, California, 92647
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
Insearch - R&H Clinical Research
Katy, Texas, 77450
Manassas Clinical Research Center
Manassas, Virginia, 20110
Progressive Medical Research
Port Orange, Florida, 32127
Cardiovascular Center of Sarasota
Sarasota, Florida, 34239
ClinEdge - Chear Center
The Bronx, New York, 10455
Orange County Research Center
Tustin, California, 92780
France1 site
Les Hôpitaux Universitaires de Strasbourg
Strasbourg, Grand Est, 67091
Germany1 site
Universitätsklinikum Schleswig-Holstein - Campus Kiel
Kiel, 24105
About this study
Official title: A Phase 3, Double-blind, Placebo-controlled, Efficacy and Safety Study of Firibastat (QGC001) Administered Orally, Twice Daily, Over 12 Weeks in Difficult-to-treat/Resistant Hypertensive Subjects
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.
Read the detailed description
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.
- Conditions
- Hypertension
- Being tested
- Firibastat, Placebo
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FiribastatDrug
Also called QGC001
Oral administration 2×250 mg capsules bid
PlaceboDrug
Oral administration 2 capsules bid
| Study group | Role | What they receive |
|---|---|---|
| Firibastat | Experimental | Capsules Receives: Drug: Firibastat |
| Placebo | Placebo comparator | Matching capsules Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Blood Pressure at office (mmHg)
Automatic Office Blood Pressure measurement
Measured: From Day 1 to Day 84
Secondary outcomes (3)
Diastolic Blood Pressure at office (mmHg)
Automatic Office Blood Pressure measurement
Measured: From Day 1 to Day 84
Mean 24-hour ambulatory Systolic Blood Pressure (mmHg)
Ambulatory Blood Pressure Monitoring
Measured: From Day 1 to Day 84
Mean 24-hour ambulatory Diastolic Blood Pressure (mmHg)
Ambulatory Blood Pressure Monitoring
Measured: From Day 1 to Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start25 Jun 2020
- Primary completion30 Aug 2022
- Study completion20 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 515 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quantum Genomics SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- George Bakris, MD, Principal investigator, AHA Comprehensive Hypertension Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04277884
- Sponsor's protocol ID
- QGC001-3QG1
- Acronym
- FRESH
- Status last verified
- Oct 2022
- First submitted
- 17 Feb 2020
- Last updated
- 20 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khosla J, Aronow WS, Frishman WH. Firibastat: An Oral First-in-Class Brain Aminopeptidase A Inhibitor for Systemic Hypertension. Cardiol Rev. 2022 Jan-Feb 01;30(1):50-55. doi: 10.1097/CRD.0000000000000360.
PubMed 33027067
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Double-blind, Placebo-controlled, Efficacy and Safety Study of Firibastat (QGC001) Administered Orally, Twice Daily, Over 12 Weeks in Difficult-to-treat/Resistant Hypertensive Subjects
- ClinicalTrials.gov ID
- NCT04277884
- Acronym / sponsor ID
- FRESH / QGC001-3QG1
- Conditions
- Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 515 participants (actual)
- Lead sponsor
- Quantum Genomics SAIndustry (pharma, biotech, devices)
- Study start
- 25 Jun 2020 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 20 Sep 2022 (actual)
- First posted
- 20 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Firibastat | Experimental | Drug: FiribastatCapsules |
| Placebo | Placebo comparator | Drug: PlaceboMatching capsules |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and women ≥18 years of age at Screening
- Diagnosis of primary HTN for at least 6 months prior to Screening
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FiribastatAlso: QGC001Oral administration 2×250 mg capsules bid | Drug | Firibastat |
| PlaceboOral administration 2 capsules bid | Drug | Placebo |
Primary outcome
Systolic Blood Pressure at office (mmHg)
Time frame: From Day 1 to Day 84
Automatic Office Blood Pressure measurement
3 secondary outcomes
Diastolic Blood Pressure at office (mmHg)
Time frame: From Day 1 to Day 84
Mean 24-hour ambulatory Systolic Blood Pressure (mmHg)
Time frame: From Day 1 to Day 84
Mean 24-hour ambulatory Diastolic Blood Pressure (mmHg)
Time frame: From Day 1 to Day 84
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2022.
- Derived from this study: PubMed 33027067Khosla J, Aronow WS, Frishman WH. Firibastat: An Oral First-in-Class Brain Aminopeptidase A Inhibitor for Systemic Hypertension. Cardiol Rev. 2022 Jan-Feb 01;30(1):50-55. doi: 10.1097/CRD.0000000000000360.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Bakris, MD principal investigator
AHA Comprehensive Hypertension Center
20 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Firibastat in people with Hypertension, run by Quantum Genomics SA at 20 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Czechia, France, Germany, Poland and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic Blood Pressure at office (mmHg) (time frame: From Day 1 to Day 84). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04277884, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2022.