Hypertension (HTN)Phase 3REFRESHNCT04857840
Randomized Study of Extended Treatment With Firibastat in Treatment-Resistant Hypertension (REFRESH)
A Phase 3 study testing Firibastat (QGC001) Period 1 in people with Hypertension (HTN), run by Quantum Genomics SA at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hypertension (HTN)
- What is being tested?
- Firibastat (QGC001) Period 1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 419 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 5 Aug 2021to 9 Jan 2023
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to understand and willing to provide written informed consent, and able to comply with the study procedures and restrictions.
- Adult men and women (at Screening).
- Diagnosis of primary HTN for at least 6 months prior to Screening and:
- Currently treated with 2 antihypertensive classes of drug (difficult-to-treat subjects), or currently treated with at least 3 antihypertensive classes of drug including a diuretic (treatment resistant subjects), at the MTDs of those medications (ie, the subject can tolerate the current dose of each medication but higher doses have caused or may worsen side effects), with no change in their antihypertensive regimen (drug, dose, or schedule) for at least 6 weeks, and with medication adherence ≥80% during the Run in Period.
- Have a systolic AOBP between 140 mmHg and 179 mmHg (inclusive) at Screening while on their current chronic antihypertensive treatments.
- Have a successful ABPM measurement with a mean systolic daytime ABP >135 mmHg after the Run-in Period while on their current chronic antihypertensive treatments. An ABPM is successful if at least 21 daytime readings and 6 nighttime readings have been successfully recorded.
Show all 17Show fewer
- Women of childbearing potential and nonsurgically sterile male subjects who are sexually active must agree to use an approved highly effective form of contraception from the time of informed consent until 30 days post dose. Approved forms of contraception include hormonal intrauterine devices, hormonal contraceptives (oral birth control pills, depo, patch, or injectable) together with supplementary barrier methods such as condoms or diaphragms with spermicidal gel or foam.
- Women of childbearing potential must have a negative serum pregnancy test result at Screening and a negative urine pregnancy test result at the Inclusion Visit (Visit 2B, Day 1)
- Subjects who meet all of the following criteria will be eligible to participate in the study:
- Able to understand and willing to provide written informed consent, and able to comply with the study procedures and restrictions.
- Adult men and women (at Screening).
- Diagnosis of primary HTN for at least 6 months prior to Screening and:
- Currently treated with 2 antihypertensive classes of drug (difficult-to-treat subjects), or currently treated with at least 3 antihypertensive classes of drug including a diuretic (treatment resistant subjects), at the MTDs of those medications (ie, the subject can tolerate the current dose of each medication but higher doses have caused or may worsen side effects), with no change in their antihypertensive regimen (drug, dose, or schedule) for at least 6 weeks, and with medication adherence ≥80% during the Run in Period.
- Have a systolic AOBP between 140 mmHg and 179 mmHg (inclusive) at Screening while on their current chronic antihypertensive treatments.
- Have a successful ABPM measurement with a mean systolic daytime ABP >135 mmHg after the Run-in Period while on their current chronic antihypertensive treatments. An ABPM is successful if at least 21 daytime readings and 6 nighttime readings have been successfully recorded.
- Women of childbearing potential and nonsurgically sterile male subjects who are sexually active must agree to use an approved highly effective form of contraception from the time of informed consent until 30 days post dose. Approved forms of contraception include hormonal intrauterine devices, hormonal contraceptives (oral birth control pills, depo, patch, or injectable) together with supplementary barrier methods such as condoms or diaphragms with spermicidal gel or foam.
- Women of childbearing potential must have a negative serum pregnancy test result at Screening and a negative urine pregnancy test result at the Inclusion Visit (Visit 2B, Day 1).
Who cannot join
- Target population:
- Subjects with uncontrolled primary HTN despite being treated with at least 2 classes of antihypertensive therapies, at the MTDs (difficult-to-treat or treatment-resistant patients).
- Subjects who meet any of the following criteria will be excluded from participation in the study:
- Known or suspected secondary HTN (eg, hyperaldosteronism, renovascular HTN, pheochromocytoma, Cushing's disease).
- Systolic AOBP ≥180 mmHg or DBP ≥110 mmHg at the Screening or Inclusion Visit (Visit 2B, 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.
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- Upper arm circumference that is outside the limits of the study-provided BP cuff associated with either the ABPM and/or AOBP measurement device.
- History of spontaneous or drug-induced angioedema.
- History of any drug-related allergy or hypersensitivity to any components of the IP (firibastat [QGC001] or placebo).
- Known severe aortic stenosis (symptomatic or asymptomatic with valvular indexed surface <0.5 cm²/m²).
- Subjects with severe symptomatic heart failure (New York Heart Association [NYHA] Class III or Class IV).
- History of acute coronary syndrome (non-ST elevation myocardial infarction [MI], ST elevation MI, and unstable angina pectoris), stroke, or transient ischemic attack within 6 months prior to Visit 2A, Day 0.
- Known history of malabsorption syndrome, or has undergone gastrointestinal surgery, including bariatric procedures that induce chronic malabsorption, within 2 years of Screening.
- Treatment with anti-obesity drugs or procedures 3 months prior to Screening (ie, surgery, aggressive diet regimen, etc.), leading to unstable body weight.
- Female who is breastfeeding, pregnant, or planning to become pregnant during the study period.
- Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 3 years.
- Shift workers who routinely sleep during the daytime and/or whose work hours include midnight.
- Subjects with moderate to severe hepatic impairment (Child-Pugh A, B, or C); alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) >3×upper limit of normal (ULN), or a total bilirubin ≥1.5×ULN (unless secondary to Gilbert's syndrome), or direct bilirubin >ULN in subjects with Gilbert's syndrome at Screening.
- Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2, as calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula (Levey AS, et al. 2009) at Screening.
- History of any blood disorder, other than sickle cell trait, causing hemolysis or unstable red blood cells (eg, malaria, babesiosis, hemolytic anemia, thalassemia, sickle cell anemia).
- Subjects with documented DI.
- Subjects with Type 1 diabetes mellitus.
- Subjects with Type 2 diabetes mellitus who:
- Are poorly controlled, defined as glycosylated hemoglobin A1c (HbA1c) >9% at Screening; OR
- Are taking short-acting insulin. Use of a stable dose [≥12 weeks prior to Screening] of the following medications, (or any combination of the following medications) is permitted: glucagon like peptide 1 analog, metformin, sulfonylurea, dipeptidyl peptidase-4 inhibitor, and single basal insulin, sodium glucose co-transporter 2 (SGLT2) inhibitors and pioglitazone.
- Routine or anticipated treatment with any systemic corticosteroid. Use of topical, inhaled, intra articular or nasal corticosteroids is permitted.
- Clinical evidence of thyroid disease, thyroid hormone therapy that is not stable ≥4 weeks prior to Screening, or a thyroid-stimulating hormone (TSH) level <0.75×lower limit of normal or >1.5×ULN at Screening.
- History of alcohol or drug abuse (including opioid overuse/misuse) within the 3 months prior to Screening that would interfere with study participation or lead to decreased compliance to study procedures or IP intake in the investigator's opinion.
- Participation in another clinical study involving an investigational drug within 30 days prior to Screening or plans to participate in another clinical study within 30 days of discontinuation of IP.
- Any other condition that precludes adequate understanding, cooperation, and compliance with study procedures or any condition that could pose a risk to the subject's safety, as per the investigator's judgment.
- Subjects with a life expectancy of less than 1 year per investigator's discretion.
- Legal incapacity or limited legal capacity.
- Previous participation in any clinical study with firibastat (QGC001).
- Subjects with any history of documented allergic reactions or allergic diseases, with the exception of documented seasonal allergies (per the investigator's decision).
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Manassas Clinical Research Center
Manassas, Virginia, 20110
About this study
Official title: A Phase 3, Double-blind, Placebo-controlled and Open-label Efficacy and Long-term Safety Study of Firibastat (QGC001) Administered Orally, Once Daily, for Up to 48 Weeks in Patients With Difficult-to-treat/Resistant Hypertension.
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.
Read the detailed description
For each subject, the study will include a Screening Visit, a Run-in Period, an Inclusion Visit (Visit 2A, Day 0, and Visit 2B, Day 1), and up to 3 study treatment periods with clinic visits and safety phone calls.
Screening assessments will be performed at Visit 1, Day -28. Eligible subjects will then enter the Run-in Period, during which medication adherence will be assessed via a medication diary. The duration of the Run in Period will be no less than 28 days and no more than 33 days; this time period allows for 2 repeat ambulatory BP monitoring (ABPM) recordings at Visit 2A, if required.
Subjects who meet the inclusion/exclusion criteria at the end of the Run in Period will be randomly assigned to either Group A or Group B. A total of 200 subjects (100 in Group A and 100 in Group B) will be randomized to continue treatment with firibastat (QGC001) during Period 3. Subjects will receive either double-blind firibastat (QGC001) or placebo for the first 12-week study treatment period (Period 1), followed by open label treatment with firibastat for 24 weeks (Period 2), or 36-weeks (Period 2 plus an additional 12-weeks of open-label treatment in Period 3).
At Visit 2A, Day 0, an ABPM device will be installed for each subject who has successfully completed the Run-in Period with a medication adherence ≥80%, and remains eligible to participate in the study. The ABPM device will be set to record for at least 24 hours, with the measurement frequency set at 30-minute intervals during the day (8:00 am to 10:00 pm [theoretically 28 readings, 2 per hour]) and 60-minute intervals at night (10:00 pm to 8:00 am [theoretically 10 readings, 1 per hour]). Subjects must have a successful ABPM measurement prior to being randomized and starting treatment with investigational product (IP) at Visit 2B, Day 1. An ABPM recording is considered successful if at least 21 daytime readings and 6 nighttime readings have been successfully recorded. A duration of less than 24 hours (e.g., 23 hours and 30 minutes) would be acceptable for a successful ABPM recording providing it successfully confirms 21 daytime readings and 6 nighttime readings. If the ABPM recording is not successful, 2 further attempts are permitted.
Following a successful ABPM recording (assessed at Visit 2B, Day 1), subjects who still meet the inclusion/exclusion criteria and who have a mean daytime systolic ambulatory blood pressure (ABP) >135 mmHg, will undergo visit-specific assessments and will be randomized to Group A or Group B, and receive either firibastat (QGC001) or placebo for the 12-week double-blind treatment period (Period 1), followed by open label firibastat for 24 weeks (Period 2), or 36 weeks (Period 2 plus Period 3 [200 subjects]), in addition to their current chronic antihypertensive treatments.
During Period 1, the investigator (or designee) will call subjects by telephone on Day 14 (±3 d) to collect any potential adverse events (AEs), check IP compliance, and record any concomitant medications. Subjects will receive a second safety phone call during Period 2, at Day 98 (±3 d).
Subjects will attend the study site for the following study visits:
Period 1: Visit 2A, Day 0; Visit 2B, Day 1; Visit 3, Day 42 (±3 d); Visit 4A, Day 84 (±3 d); and Visit 4B, Day 85 (±3 d).
Period 2: Visit 5, Day 126 (±3 d); Visit 6, Day 168 (±3 d); Visit 7, Day 252 (±3 d); and Visit 8, Day 280 (±3 d).
Period 3:Visit 9, Day 336 (±3 d), and Visit 10, Day 364 (±3 d). On completion of their final study treatment period, subjects will attend an End of Treatment (EOT) Visit. A safety follow-up will be performed at the End of Study (EOS) Visit.
For subjects who stop study treatment at the end of Period 2, the EOT Visit will be at Visit 7, Day 252 (±3 d), and the EOS Visit will be Visit 8, Day 280 (±3 d).
Subjects who continue study treatment into Period 3 will not attend Visit 8, Day 280 (±3 d). Subjects who stop treatment with firibastat (QGC001) after Period 3 will attend an EOT Visit at Visit 9, Day 336 (±3 d), and an EOS Visit at Visit 10, Day 364 (±3 d).
Subjects who discontinue the study early should undergo an Early Termination Visit, and an EOS visit 28 days (±3 d) after the last dose of IP (except in the case of consent withdrawal).
Each subject will be assigned to one of 5 pharmacokinetic (PK) subgroups; 50 subjects (at selected sites) will undergo an enhanced PK sampling schedule (6 PK samples will be collected according to the PK subgroup sampling schedule), and 700 subjects will be assigned to the standard PK sampling schedule (2 PK samples will be collected according to the PK subgroup sampling schedule).
At each study visit, AOBP, orthostatic BP, and heart rate (HR) will be measured, and other visit-specific procedures will be performed, including electrocardiograms (ECGs), clinical laboratory evaluations, clinical examinations, collection of blood for PK samples and the biomarker N terminal pro-B-type natriuretic peptide (NT-ProBNP), and monitoring of AEs and concomitant medications. At the EOS Visit (safety follow-up) assessments will include clinical examination, AOBP, orthostatic BP, ECG, HR, and clinical laboratory assessments, AE monitoring, and concomitant medications.
Allergic skin reactions and/or diabetes insipidus (DI) are considered adverse events of special interest (AESIs) with immediate notification during the study treatment period.
- Conditions
- Hypertension (HTN)
- Being tested
- Firibastat (QGC001) Period 1
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Firibastat (QGC001) Period 1Drug
Also called Firibastat (QGC001) Open label
1000 mg (2 x 500 mg) tablets QD per Os
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Investigational Product /Period 1,2 and 3 if any (open label) | Experimental | Firibastat 1000 mg tablets QD - 12 weeks Receives: Drug: Firibastat (QGC001) Period 1 |
| Arm B: Placebo/Period1 only | Placebo comparator | Placebo tablets QD 12 weeks in Period 1 only, followed by open label Period 2 and 3 if any. Receives: Drug: Firibastat (QGC001) Period 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy endpoint is the change from baseline in systolic AOBP at Week 12.
The main criterion will be analyzed with a mixed model with repeated measures (MMRM) at Week 6 (Day 42) and Week 12 (Day 84), with an unstructured matrix of covariance.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start5 Aug 2021
- Primary completion9 Jan 2023
- Study completion9 Jan 2023
Why it stopped: No Efficacy demonstrated inn the QGC001-3QG1 study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension (HTN)Studies 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
- Model description
- 2 Arms : Double-blind placebo controlled during Period 1 of 12 weeks followed by open-label periods 2 (24 weeks) and 3 (12 weeks)
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 419 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quantum Genomics SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Responsible party
- Sponsor
- Investigators
- Georges GB BAKRIS, MD, Study chair, AHA Comprehensive Hypertension Center University of Chicago Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04857840
- Sponsor's protocol ID
- QGC001-3QG2
- Acronym
- REFRESH
- Status last verified
- Jan 2023
- First submitted
- 20 Apr 2021
- Last updated
- 17 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Double-blind, Placebo-controlled and Open-label Efficacy and Long-term Safety Study of Firibastat (QGC001) Administered Orally, Once Daily, for Up to 48 Weeks in Patients With Difficult-to-treat/Resistant Hypertension.
- ClinicalTrials.gov ID
- NCT04857840
- Acronym / sponsor ID
- REFRESH / QGC001-3QG2
- Conditions
- Hypertension (HTN)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No Efficacy demonstrated inn the QGC001-3QG1 study
- Enrolment
- 419 participants (actual)
- Lead sponsor
- Quantum Genomics SAIndustry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Study start
- 5 Aug 2021 (actual)
- Primary completion
- 9 Jan 2023 (actual)
- Study completion
- 9 Jan 2023 (actual)
- First posted
- 23 Apr 2021 (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 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.
Detailed description
For each subject, the study will include a Screening Visit, a Run-in Period, an Inclusion Visit (Visit 2A, Day 0, and Visit 2B, Day 1), and up to 3 study treatment periods with clinic visits and safety phone calls.
Screening assessments will be performed at Visit 1, Day -28. Eligible subjects will then enter the Run-in Period, during which medication adherence will be assessed via a medication diary. The duration of the Run in Period will be no less than 28 days and no more than 33 days; this time period allows for 2 repeat ambulatory BP monitoring (ABPM) recordings at Visit 2A, if required.
Subjects who meet the inclusion/exclusion criteria at the end of the Run in Period will be randomly assigned to either Group A or Group B. A total of 200 subjects (100 in Group A and 100 in Group B) will be randomized to continue treatment with firibastat (QGC001) during Period 3. Subjects will receive either double-blind firibastat (QGC001) or placebo for the first 12-week study treatment period (Period 1), followed by open label treatment with firibastat for 24 weeks (Period 2), or 36-weeks (Period 2 plus an additional 12-weeks of open-label treatment in Period 3).
At Visit 2A, Day 0, an ABPM device will be installed for each subject who has successfully completed the Run-in Period with a medication adherence ≥80%, and remains eligible to participate in the study. The ABPM device will be set to record for at least 24 hours, with the measurement frequency set at 30-minute intervals during the day (8:00 am to 10:00 pm [theoretically 28 readings, 2 per hour]) and 60-minute intervals at night (10:00 pm to 8:00 am [theoretically 10 readings, 1 per hour]). Subjects must have a successful ABPM measurement prior to being randomized and starting treatment with investigational product (IP) at Visit 2B, Day 1. An ABPM recording is considered successful if at least 21 daytime readings and 6 nighttime readings have been successfully recorded. A duration of less than 24 hours (e.g., 23 hours and 30 minutes) would be acceptable for a successful ABPM recording providing it successfully confirms 21 daytime readings and 6 nighttime readings. If the ABPM recording is not successful, 2 further attempts are permitted.
Following a successful ABPM recording (assessed at Visit 2B, Day 1), subjects who still meet the inclusion/exclusion criteria and who have a mean daytime systolic ambulatory blood pressure (ABP) >135 mmHg, will undergo visit-specific assessments and will be randomized to Group A or Group B, and receive either firibastat (QGC001) or placebo for the 12-week double-blind treatment period (Period 1), followed by open label firibastat for 24 weeks (Period 2), or 36 weeks (Period 2 plus Period 3 [200 subjects]), in addition to their current chronic antihypertensive treatments.
During Period 1, the investigator (or designee) will call subjects by telephone on Day 14 (±3 d) to collect any potential adverse events (AEs), check IP compliance, and record any concomitant medications. Subjects will receive a second safety phone call during Period 2, at Day 98 (±3 d).
Subjects will attend the study site for the following study visits:
Period 1: Visit 2A, Day 0; Visit 2B, Day 1; Visit 3, Day 42 (±3 d); Visit 4A, Day 84 (±3 d); and Visit 4B, Day 85 (±3 d).
Period 2: Visit 5, Day 126 (±3 d); Visit 6, Day 168 (±3 d); Visit 7, Day 252 (±3 d); and Visit 8, Day 280 (±3 d).
Period 3:Visit 9, Day 336 (±3 d), and Visit 10, Day 364 (±3 d). On completion of their final study treatment period, subjects will attend an End of Treatment (EOT) Visit. A safety follow-up will be performed at the End of Study (EOS) Visit.
For subjects who stop study treatment at the end of Period 2, the EOT Visit will be at Visit 7, Day 252 (±3 d), and the EOS Visit will be Visit 8, Day 280 (±3 d).
Subjects who continue study treatment into Period 3 will not attend Visit 8, Day 280 (±3 d). Subjects who stop treatment with firibastat (QGC001) after Period 3 will attend an EOT Visit at Visit 9, Day 336 (±3 d), and an EOS Visit at Visit 10, Day 364 (±3 d).
Subjects who discontinue the study early should undergo an Early Termination Visit, and an EOS visit 28 days (±3 d) after the last dose of IP (except in the case of consent withdrawal).
Each subject will be assigned to one of 5 pharmacokinetic (PK) subgroups; 50 subjects (at selected sites) will undergo an enhanced PK sampling schedule (6 PK samples will be collected according to the PK subgroup sampling schedule), and 700 subjects will be assigned to the standard PK sampling schedule (2 PK samples will be collected according to the PK subgroup sampling schedule).
At each study visit, AOBP, orthostatic BP, and heart rate (HR) will be measured, and other visit-specific procedures will be performed, including electrocardiograms (ECGs), clinical laboratory evaluations, clinical examinations, collection of blood for PK samples and the biomarker N terminal pro-B-type natriuretic peptide (NT-ProBNP), and monitoring of AEs and concomitant medications. At the EOS Visit (safety follow-up) assessments will include clinical examination, AOBP, orthostatic BP, ECG, HR, and clinical laboratory assessments, AE monitoring, and concomitant medications.
Allergic skin reactions and/or diabetes insipidus (DI) are considered adverse events of special interest (AESIs) with immediate notification during the study treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- 2 Arms : Double-blind placebo controlled during Period 1 of 12 weeks followed by open-label periods 2 (24 weeks) and 3 (12 weeks)
| Arm | Type | Receives |
|---|---|---|
| Arm A: Investigational Product /Period 1,2 and 3 if any (open label) | Experimental | Drug: Firibastat (QGC001) Period 1Firibastat 1000 mg tablets QD - 12 weeks |
| Arm B: Placebo/Period1 only | Placebo comparator | Drug: Firibastat (QGC001) Period 1Placebo tablets QD 12 weeks in Period 1 only, followed by open label Period 2 and 3 if any. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Able to understand and willing to provide written informed consent, and able to comply with the study procedures and restrictions.
- Adult men and women (at Screening).
- Diagnosis of primary HTN for at least 6 months prior to Screening and:
- Women of childbearing potential and nonsurgically sterile male subjects who are sexually active must agree to use an approved highly effective form of contraception from the time of informed consent until 30 days post dose. Approved forms of contraception include hormonal intrauterine devices, hormonal contraceptives (oral birth control pills, depo, patch, or injectable) together with supplementary barrier methods such as condoms or diaphragms with spermicidal gel or foam.
- Women of childbearing potential must have a negative serum pregnancy test result at Screening and a negative urine pregnancy test result at the Inclusion Visit (Visit 2B, Day 1)
Key exclusion criteria (34 listed)
- Target population:
- Subjects with uncontrolled primary HTN despite being treated with at least 2 classes of antihypertensive therapies, at the MTDs (difficult-to-treat or treatment-resistant patients).
- Subjects who meet any of the following criteria will be excluded from participation in the study:
- Known or suspected secondary HTN (eg, hyperaldosteronism, renovascular HTN, pheochromocytoma, Cushing's disease).
- Systolic AOBP ≥180 mmHg or DBP ≥110 mmHg at the Screening or Inclusion Visit (Visit 2B, Day 1) and confirmed by a second measurement within 30 minutes to 1 hour.
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 |
|---|---|---|
| Firibastat (QGC001) Period 1Also: Firibastat (QGC001) Open label1000 mg (2 x 500 mg) tablets QD per Os | Drug | Arm A: Investigational Product /Period 1,2 and 3 if any (open label), Arm B: Placebo/Period1 only |
Primary outcome
The primary efficacy endpoint is the change from baseline in systolic AOBP at Week 12.
Time frame: 12 weeks
The main criterion will be analyzed with a mixed model with repeated measures (MMRM) at Week 6 (Day 42) and Week 12 (Day 84), with an unstructured matrix of covariance.
Results and safety
The study was stopped early (reason given: No Efficacy demonstrated inn the QGC001-3QG1 study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
- 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.
Georges GB BAKRIS, MD study chair
AHA Comprehensive Hypertension Center University of Chicago Medical Center
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Firibastat (QGC001) Period 1 in people with Hypertension (HTN), run by Quantum Genomics SA at 2 sites in 2 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 17 inclusion and 34 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: stopped early, as of the sponsor's last update on 17 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. 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 was stopped early (reason given: No Efficacy demonstrated inn the QGC001-3QG1 study). Results are not available in the source record.
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?
The primary efficacy endpoint is the change from baseline in systolic AOBP at Week 12. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jan 2023; AzTrials last refreshed its copy on 7 Nov 2026.