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    Clinical Trial Results:
    Multicenter, randomized, double-blind, two-period, placebo controlled, forced-titration proof of concept crossover study to compare QGC001 with placebo in patients with grade I or II essential hypertension

    Summary
    EudraCT number
    2014-003071-37
    Trial protocol
    FR  
    Global end of trial date
    13 Apr 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    18 May 2017
    First version publication date
    18 May 2017
    Other versions
    Summary report(s)
    synopsisQGC001

    Trial information

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    Trial identification
    Sponsor protocol code
    QGC001/2QG1
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Quantum Genomics
    Sponsor organisation address
    Tour Montparnasse, 33 avenue du Maine, Paris, France, 75015
    Public contact
    Pr M. Azizi, MD, PhD, Hôpital Européen Georges Pompidou, 75015 Paris, France, Assistance-Publique- Hôpitaux de Paris Hôpital Européen Georges Pompidou, 75015 Paris, France, +33 1 56 09 3989, michel.azizi@egp.aphp.fr
    Scientific contact
    Olivier Madonna, MD Tour Montparnasse, 33 avenue du Maine, 75015 Paris, France , Quantum Genomics Tour Montparnasse, 33 avenue du Maine 75015, Paris, +33 1 85 34 77 73 , olivier.madonna@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
    13 Apr 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Apr 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Apr 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the BP lowering effect of 4-week administration of QGC001 oral doses in patients with grade I or II essential hypertension compared to placebo.
    Protection of trial subjects
    This study was conducted in accordance with Good Clinical Practice standards, ethical principles stated in the Declaration of Helsinki and applicable regulatory requirements. After the subject has ended his/her participation in the trial, the investigator provided appropriate medication and/or arranged access to appropriate care for the patient.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    23 Feb 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 40
    Worldwide total number of subjects
    40
    EEA total number of subjects
    40
    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)
    31
    From 65 to 84 years
    9
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    This study was performed in male and female of non-childbearing potential, aged 18 to 75 years, with a BMI of 18 to 40 kg/m2, with essential grade I or II hypertension, a diagnosis of permanent hypertension, an estimated glomerular filtration rate ≥ 60 mL/min/1.73 m2, and a signed and dated informed consent form before any screening procedure.

    Pre-assignment
    Screening details
    50 subjects were screened and 40 were included in the run-in period (= pre-assignment period). The screening period included a period of tapering and discontinuation of current antihypertensive therapy for 2 weeks if needed. Patients untreated at screening directly entered the run-in period, which consisted of 2 weeks of placebo treatment.

    Pre-assignment period milestones
    Number of subjects started
    40
    Number of subjects completed
    34 [1]

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    Protocol deviation: 5
    Reason: Number of subjects
    Consent withdrawn by subject: 1
    Notes
    [1] - The number of subjects reported to be in the pre-assignment period is not consistent with the number starting period 1. It is expected that the number completing the pre-assignment period are also present in the arms in period 1.
    Justification: During the pre-assignement period, 6 subjects were withdrawn.
    Period 1
    Period 1 title
    cross-over period (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Investigator, Subject
    Blinding implementation details
    The randomization was stratified by center, and investigating centers allocated the therapeutic units (TU) by order of patient’s inclusion in each center, using the TU kits available to each center.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    QGC001
    Arm description
    Patients were randomised to one of the 2 sequences of treatment, either QGC001/placebo or placebo/QGC001 (2-way cross over). Patients underwent two four-week treatment arms where they received either QGC001 or placebo. Each arm was separated by a two-week washout period where patient received placebo (as one capsule every 12 hours (08:00 am and 20:00 pm) for one week followed by 2 capsules every 12 hours (08:00 am and 20:00h) for 1 week). This arm concerns the QGC001 treatment.
    Arm type
    Experimental

    Investigational medicinal product name
    QGC001 250 mg
    Investigational medicinal product code
    QGC001
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    In this arm, patients received QGC001 250 mg b.i.d. during one week, as one 250 mg capsule every 12 hours (08:00 am and 08:00 pm) followed by QGC001 500 mg b.i.d. during three weeks, as two 250 mg capsules every 12 hours (08:00 am and 08:00h).

    Arm title
    placebo
    Arm description
    Patients were randomised to one of the 2 sequences of treatment, either QGC001/placebo or placebo/QGC001 (2-way cross over). Patients underwent two four-week treatment arms where they received either QGC001 or placebo. Each arm was separated by a two-week washout period where patient received placebo (as one capsule every 12 hours (08:00 am and 20:00 pm) for one week followed by 2 capsules every 12 hours (08:00 am and 20:00h) for 1 week). This arm concerns the placebo treatment.
    Arm type
    Placebo

    Investigational medicinal product name
    QGC001 placebo
    Investigational medicinal product code
    QGC001
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    In this arm, patients received placebo during one week, as one capsule every 12 hours (08:00 am and 08:00 pm) followed by placebo during three weeks, as 2 capsules every 12 hours (08:00 am and 08:00 pm).

    Number of subjects in period 1
    QGC001 placebo
    Started
    33
    33
    Completed
    30
    32
    Not completed
    3
    1
         Consent withdrawn by subject
    1
    -
         Physician decision
    -
    1
         Adverse event, non-fatal
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups [1]
    Reporting group title
    cross-over period
    Reporting group description
    -

    Notes
    [1] - The number of subjects reported to be in the baseline period is not equal to the worldwide number of subjects enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The worldwide number of subjects corresponds to the number of subjects who started the pre-assignment period, whereas the number of subjects in the baseline period corresponds to the number of subjects who entered the cross-over period after the pre-assignement period. During the pre-assignement period, 6 subjects were withdrawn.
    Reporting group values
    cross-over period Total
    Number of subjects
    34 34
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    27 27
        From 65-84 years
    7 7
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    56.6 ( 9.1 ) -
    Gender categorical
    Units: Subjects
        Female
    9 9
        Male
    25 25

    End points

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    End points reporting groups
    Reporting group title
    QGC001
    Reporting group description
    Patients were randomised to one of the 2 sequences of treatment, either QGC001/placebo or placebo/QGC001 (2-way cross over). Patients underwent two four-week treatment arms where they received either QGC001 or placebo. Each arm was separated by a two-week washout period where patient received placebo (as one capsule every 12 hours (08:00 am and 20:00 pm) for one week followed by 2 capsules every 12 hours (08:00 am and 20:00h) for 1 week). This arm concerns the QGC001 treatment.

    Reporting group title
    placebo
    Reporting group description
    Patients were randomised to one of the 2 sequences of treatment, either QGC001/placebo or placebo/QGC001 (2-way cross over). Patients underwent two four-week treatment arms where they received either QGC001 or placebo. Each arm was separated by a two-week washout period where patient received placebo (as one capsule every 12 hours (08:00 am and 20:00 pm) for one week followed by 2 capsules every 12 hours (08:00 am and 20:00h) for 1 week). This arm concerns the placebo treatment.

    Primary: day-time mean SBP changes from baseline

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    End point title
    day-time mean SBP changes from baseline
    End point description
    End point type
    Primary
    End point timeframe
    the primary endpoint was the comparison of change from baseline of daytime mean SBP as calculated from the individual ABPM after 4 weeks of treatment between treatments, in the ITT set.
    End point values
    QGC001 placebo
    Number of subjects analysed
    30
    32
    Units: mmHg
        arithmetic mean (standard deviation)
    -1.88 ( 8.13 )
    0.68 ( 9.34 )
    Statistical analysis title
    day-time mean SBP changes ANOVA
    Statistical analysis description
    The comparisons between treatments of daytime mean SBP were analyzed using an analysis of variance (ANOVA) on change from baseline to 4 weeks of treatment with treatment group, sequence, period and center as fixed effects and subject within sequence as random effect. The estimate and the 95% CI of the difference between QGC001 and placebo were calculated.
    Comparison groups
    QGC001 v placebo
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.1573
    Method
    ANOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -2.69
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -6.47
         upper limit
    1.1

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Subjects were required to report any AE that occurred after informed consent was signed. All AEs that occurred from the time of informed consent until 1 week after 24 hours after Day 8 of the second arm of the sequence of treatment were recorded.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    QGC001
    Reporting group description
    Patients underwent a run-in epriod of 2 weeks during which they recieved placebo, followed by two four-week treatment arms, in which they received either QGC001 or placebo (2-way cross-over), separated by a two-week washout period where they received placebo (as one capsule every 12 hours (08:00 am and 20:00 pm) for one week followed by 2 capsules every 12 hours (08:00 am and 20:00h) for 1 week. This reporting group concerns the QGC001 treatment.

    Reporting group title
    placebo
    Reporting group description
    Patients underwent two four-week treatment periods separated by a two-week washout period where they received placebo (as one capsule every 12 hours (08:00 am and 20:00 pm) for one week followed by 2 capsules every 12 hours (08:00 am and 20:00h) for 1 week. In each period, they received either QGC001 or placebo. This arm concerns the placebo treatment.

    Reporting group title
    Run-in Period
    Reporting group description
    -

    Reporting group title
    washout period
    Reporting group description
    -

    Serious adverse events
    QGC001 placebo Run-in Period washout period
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    Ear and labyrinth disorders
    Vestibular disorder
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash macular
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    QGC001 placebo Run-in Period washout period
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 32 (3.13%)
    1 / 32 (3.13%)
    2 / 33 (6.06%)
    2 / 32 (6.25%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 32 (3.13%)
    1 / 32 (3.13%)
    2 / 33 (6.06%)
    2 / 32 (6.25%)
         occurrences all number
    1
    1
    2
    2

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Mar 2015
    The purpose of the amendment was to modify inclusion criterion N°5, in order to reflect international guidelines and the upper limits of normal range for the definition of the mean SBP and DBP for the diagnosis of permanent hypertension. In V1.0 of the protocol, inclusion criterion N°5 was: 5/ Diagnosis of permanent hypertension confirmed by a mean SBP or DBP higher than 135 or 85 mmHg on daytime ambulatory blood pressure monitoring (ABPM) after a 2‑week placebo run-in period. In V2.0 of the protocol, the criterion became:5/ Diagnosis of permanent hypertension confirmed by a mean SBP or DBP equal to or higher than 135 or 85 mmHg on daytime ambulatory blood pressure monitoring (ABPM) after a 2-week placebo run-in period.

    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
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