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    Clinical Trial Results:
    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

    Summary
    EudraCT number
    		 2019-004509-29
    Trial protocol
    		 FR   DE   PL   ES   CZ   HU   BG  
    Global end of trial date
    20 Sep 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Mar 2023
    First version publication date
    04 Mar 2023
    Other versions
    Summary report(s)
    		 CSR Synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    QGC001-3QG1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04277884
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Quantum Genomics
    Sponsor organisation address
    33 rue Marbeuf, Paris, France,
    Public contact
    Bruno Besse, Quantum Genomics, 33 185347770, bruno.besse@quantum-genomics.com
    Scientific contact
    Bruno Besse, Quantum Genomics, 33 185347770, bruno.besse@quantum-genomics.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    07 Oct 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Sep 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Sep 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective 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 despite being treated with 2 classes of antihypertensive therapies, at the maximum tolerated doses (MTDs). The secondary objective is to assess the safety of firibastat (QGC001).
    Protection of trial subjects
    Subjects were followed for a period of 3 months after randomization with relugar visits (every month) and criteria of discontinuation were added in the protocol on some safety criteria. A 28 days FU visit after last IP intake was planned.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 May 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 129
    Country: Number of subjects enrolled
    Spain: 40
    Country: Number of subjects enrolled
    Bulgaria: 45
    Country: Number of subjects enrolled
    Czechia: 28
    Country: Number of subjects enrolled
    France: 8
    Country: Number of subjects enrolled
    Germany: 22
    Country: Number of subjects enrolled
    Hungary: 15
    Country: Number of subjects enrolled
    Brazil: 54
    Country: Number of subjects enrolled
    Canada: 44
    Country: Number of subjects enrolled
    Mexico: 5
    Country: Number of subjects enrolled
    United States: 124
    Worldwide total number of subjects
    514
    EEA total number of subjects
    287
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    253
    From 65 to 84 years
    256
    85 years and over
    5

    Subject disposition

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    Recruitment
    Recruitment details
    		 Target population: Subjects with uncontrolled primary HTN despite being treated with at least 3 classes of antihypertensive therapies, including a diuretic, for treatment-resistant subjects or 2 classes of antihypertensive therapies (including or not including a diuretic), for difficult-to-treat subjects at the MTDs.

    Pre-assignment
    Screening details
    		 Screening visit is followed by a Run-in period of 28 days. During Run-in the subject is requested to take his/her current HTN treatment everyday. A measure of APBM is done at the end of the Run-In period and the subject is eligible with an ABPM measurement with a mean systolic daytime ABP >135 mmHg after the Run-in Period.

    Period 1
    Period 1 title
    Treatment period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Firibastat 500mg BID
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Firibastat
    Investigational medicinal product code
    QGC001
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Dose: 500 mg (2×250 mg capsules) bid

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Dose: 2 capsules bid

    Number of subjects in period 1
    		Firibastat 500mg BID Placebo
    Started
    255
    259
    Completed
    204
    219
    Not completed
    51
    40
         Adverse event, serious fatal
    1
    -
         Consent withdrawn by subject
    11
    8
         Physician decision
    1
    2
         Adverse event, non-fatal
    14
    9
         Various other reasons
    9
    17
         Skin reaction
    13
    1
         Severe hypertension
    -
    1
         Lost to follow-up
    1
    1
         Protocol deviation
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment period
    Reporting group description
    		 -

    Reporting group values
    		 Treatment period Total
    Number of subjects
    		 514 514
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 63.4 (27 to 88) -
    Gender categorical
    Units: Subjects
        Female
    		 214 214
        Male
    		 300 300

    End points

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    End points reporting groups
    Reporting group title
    Firibastat 500mg BID
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Subject analysis set title
    Full analysis
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All randomized subjects with at least one consumption of study product (Firibastat or placebo).

    Subject analysis set title
    Per Protocol Set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All Ffull analysis set subjects without any major for primary endpoint deviation to the present protocol.

    Primary: Change in systolic AOPB from baseline to week 12

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    End point title
    		 Change in systolic AOPB from baseline to week 12
    End point description
    End point type
    Primary
    End point timeframe
    Week 12
    End point values
    		 Firibastat 500mg BID Placebo
    Number of subjects analysed
    255
    259
    Units: mmHg
        arithmetic mean (confidence interval 95%)
    -7.82 (-9.79 to -5.85)
    -7.85 (-9.77 to -5.93)
    Statistical analysis title
    		 Primary analysis of the primary efficacy endpoint
    Statistical analysis description
    The main criterion will be analyzed with a mixed model with repeated measures (MMRM) with baseline as covariate and time, treatment and interaction between time and treatment as fixed effect as defined in part 2.5. Structure of the covariance matrix will be the unstructured one. Adjusted means (LS-Means) and difference of adjusted means between Firibastat and Placebo will be estimated with 95% confidence interval.
    Comparison groups
    Firibastat 500mg BID v Placebo
    Number of subjects included in analysis
    514
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9844
    Method
    		 Mixed models analysis
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From ICF signature at screening visit to end of study FU visit (28 days after and of treatment)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23
    Reporting groups
    Reporting group title
    Firibastat 500mg
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Firibastat 500mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 255 (2.75%)
    3 / 259 (1.16%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    1
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    MENINGIOMA
         subjects affected / exposed
    1 / 255 (0.39%)
    0 / 259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    CARDIAC FAILURE ACUTE
         subjects affected / exposed
    1 / 255 (0.39%)
    0 / 259 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ATRIAL FIBRILLATION
         subjects affected / exposed
    0 / 255 (0.00%)
    1 / 259 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    PROSTATECTOMY
         subjects affected / exposed
    0 / 255 (0.00%)
    1 / 259 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    DIZZINESS
         subjects affected / exposed
    0 / 255 (0.00%)
    1 / 259 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    NORMOCYTIC ANAEMIA
         subjects affected / exposed
    1 / 255 (0.39%)
    0 / 259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    ASTHENIA
         subjects affected / exposed
    1 / 255 (0.39%)
    0 / 259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    RETINOPATHY HYPERTENSIVE
         subjects affected / exposed
    0 / 255 (0.00%)
    1 / 259 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    GASTROINTESTINAL HAEMORRHAGE
         subjects affected / exposed
    1 / 255 (0.39%)
    0 / 259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MESENTERIC ARTERY STENOSIS
         subjects affected / exposed
    1 / 255 (0.39%)
    0 / 259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    DEPRESSION
         subjects affected / exposed
    0 / 255 (0.00%)
    1 / 259 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19 PNEUMONIA
         subjects affected / exposed
    1 / 255 (0.39%)
    0 / 259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Metabolism and nutrition disorders
    MALNUTRITION
         subjects affected / exposed
    1 / 255 (0.39%)
    0 / 259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Firibastat 500mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    100 / 255 (39.22%)
    88 / 259 (33.98%)
    Investigations
    BLOOD CREATINE PHOSPHOKINASE INCREASED
         subjects affected / exposed
    4 / 255 (1.57%)
    3 / 259 (1.16%)
         occurrences all number
    4
    3
    Vascular disorders
    ORTHOSTATIC HYPOTENSION
         subjects affected / exposed
    15 / 255 (5.88%)
    16 / 259 (6.18%)
         occurrences all number
    18
    18
    HYPERTENSION
         subjects affected / exposed
    4 / 255 (1.57%)
    3 / 259 (1.16%)
         occurrences all number
    4
    3
    Cardiac disorders
    ATRIAL FIBRILATION
         subjects affected / exposed
    2 / 255 (0.78%)
    3 / 259 (1.16%)
         occurrences all number
    2
    3
    Nervous system disorders
    HEADACHE
         subjects affected / exposed
    9 / 255 (3.53%)
    9 / 259 (3.47%)
         occurrences all number
    9
    9
    DIZZINESS
         subjects affected / exposed
    7 / 255 (2.75%)
    5 / 259 (1.93%)
         occurrences all number
    8
    6
    General disorders and administration site conditions
    FATIGUE
         subjects affected / exposed
    5 / 255 (1.96%)
    3 / 259 (1.16%)
         occurrences all number
    5
    3
    ASTHENIA
         subjects affected / exposed
    4 / 255 (1.57%)
    2 / 259 (0.77%)
         occurrences all number
    4
    2
    Gastrointestinal disorders
    DYSPEPSIA
         subjects affected / exposed
    1 / 255 (0.39%)
    6 / 259 (2.32%)
         occurrences all number
    1
    6
    DIARRHOEA
         subjects affected / exposed
    3 / 255 (1.18%)
    3 / 259 (1.16%)
         occurrences all number
    3
    3
    NAUSEA
         subjects affected / exposed
    3 / 255 (1.18%)
    2 / 259 (0.77%)
         occurrences all number
    3
    2
    Skin and subcutaneous tissue disorders
    RASH
         subjects affected / exposed
    6 / 255 (2.35%)
    2 / 259 (0.77%)
         occurrences all number
    6
    2
    PRURITUS
         subjects affected / exposed
    4 / 255 (1.57%)
    2 / 259 (0.77%)
         occurrences all number
    4
    2
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA
         subjects affected / exposed
    5 / 255 (1.96%)
    1 / 259 (0.39%)
         occurrences all number
    5
    1
    BACK PAIN
         subjects affected / exposed
    4 / 255 (1.57%)
    2 / 259 (0.77%)
         occurrences all number
    4
    2
    Infections and infestations
    COVID-19
         subjects affected / exposed
    6 / 255 (2.35%)
    8 / 259 (3.09%)
         occurrences all number
    6
    8
    NASOPHARYNGITIS
         subjects affected / exposed
    4 / 255 (1.57%)
    2 / 259 (0.77%)
         occurrences all number
    4
    2
    INFLUENZA
         subjects affected / exposed
    2 / 255 (0.78%)
    4 / 259 (1.54%)
         occurrences all number
    2
    4
    Metabolism and nutrition disorders
    HYPERTRIGLYCERIDAEMIA
         subjects affected / exposed
    6 / 255 (2.35%)
    4 / 259 (1.54%)
         occurrences all number
    6
    4
    HYPERCHOLESTEROLEMIA
         subjects affected / exposed
    4 / 255 (1.57%)
    4 / 259 (1.54%)
         occurrences all number
    4
    4
    HYPERURICAEMIA
         subjects affected / exposed
    3 / 255 (1.18%)
    4 / 259 (1.54%)
         occurrences all number
    3
    5
    HYPERGLYCAEMIA
         subjects affected / exposed
    5 / 255 (1.96%)
    1 / 259 (0.39%)
         occurrences all number
    5
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Jan 2020
    Major changes : Added ‘Subjects with moderate to severe hepatic impairment (Child-Pugh B or C)’ to exclusion criteria #15. Added blood sample for coagulation test (prothrombin time) at Screening to enable assessment of Child-Pugh classification of hepatic impairment. Deleted analysis of blood samples for the biomarkers TNFR1 and copeptin.
    27 Oct 2020
    Harmonisation of all local Protocols Inclusion of COVID risk measures
    31 Mar 2021
    Eligible systolic automated office blood pressure (AOBP) range updated from 140-170 mmHg to 140-180 mmHg. Updated screen failures, to allow for rescreening

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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