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    EudraCT Number:2014-003071-37
    Sponsor's Protocol Code Number:QGC001/2QG1
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-06-26
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2014-003071-37
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to investigate the efficacy of QGC001 in patients affected by high blood pressure.
    A.4.1Sponsor's protocol code numberQGC001/2QG1
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorQuantum Genomics
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportQuantum Genomics
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAssistance Publique – Hopitaux de Paris
    B.5.2Functional name of contact pointM. Azizi
    B.5.3 Address:
    B.5.3.1Street Address20-40 rue Leblanc
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75015
    B.5.4Telephone number+33 1 56 09 3989
    B.5.5Fax number+33 1 56 09 2929
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code QGC001
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameQGC001
    D.3.9.4EV Substance CodeSUB33157
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hyperactivity of the brain renin-angiotensin system participates to the development and maintenance of essential Hypertension
    E.1.1.1Medical condition in easily understood language
    Treatment of essential hypertension
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10015488
    E.1.2Term Essential hypertension
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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.
    E.2.2Secondary objectives of the trial
    •To assess the safety and tolerability of 4-week administration of QGC001 oral doses in patients with grade I or II essential hypertension compared to placebo
    •To obtain preliminary PK information for QGC001 given as multiple oral doses
    •To determine preliminary PD profile of QGC001 multiple oral doses on plasma and urine hormones, which will be compared to that of placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female of non-childbearing potential patients (post-menopausal since at least 12 months or surgically sterilized) aged 18 to 75 years of age;
    2. Body weight ≥50 kg with a body mass index (BMI) calculated as weight in kg/(height in m2) from 18 to 40 kg/m2 at screening;
    3. A signed and dated informed consent form before any study-specific screening procedure is performed;
    4. With a diagnosis of essential grade I or II hypertension defined as:
    • a supine office systolic BP (SBP) of 140–159 mmHg or diastolic BP (DBP) of 90–99 mmHg who should have an additional clinical indication for antihypertensive treatment according to ESH guidelines after a 2-week placebo run-in period,
    • or a supine office SBP of 160-179 mmHg or DBP of 100–109 mmHg after a 2-week placebo run-in period with a diagnosis of essential grade II hypertension;
    5. The diagnosis of permanent hypertension will be 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;
    6. Estimated glomerular filtration rate (Modification of Diet in Renal Disease (MDRD) formula) ≥ 60 ml/min/1.73 m2.
    E.4Principal exclusion criteria
    1. Any significant hepatic, renal, respiratory (e.g., asthma), gastrointestinal, endocrine (e.g., diabetes, dyslipidemia necessitating drug therapy), immunologic, dermatological, hematological, neurologic, psychiatric disease or history of any clinically important drug
    2. Acute disease state (e.g., vomiting, fever, diarrhea) within 7 days before study day 1;
    3. History of transient ischemic accident (TIA) or cerebrovascular accident (CVA) during the 6 months prior to screening;
    4. History of acute heart failure or heart failure (NYHA class II-IV) within the 6 months prior to screening;
    5. History of myocardial infarction, unstable angina, coronary bypass or percutaneous coronary angioplasty during the 6 months prior to screening;
    6. History of malignant tumor during the past 5 years;
    7. Any medical or surgical disorder considered by the investigator as increasing the risks of participation in the study, or liable to prevent the patient from complying with the equirements of the study or from continuing the study to completion;
    8. Any situation which, in the investigator's opinion, might compromise assessment of efficacy or of safety;
    9. History of non-adherence to treatment;
    10. History of drug abuse within 1 year before study day 1;
    11. History of alcoholism within 1 year before day 1;
    12. Positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis Bsurface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies;
    13. Use of any investigational drug within 30 days before IMP administration;
    14. Donation of blood (i.e., 500 ml) within 90 days before study day 1;
    15. Known secondary hypertension;
    16. Grade III hypertension;
    17. Estimated glomerular filtration rate (MDRD formula) below 60 ml/min/1.73 m2;
    18. Type I diabetes mellitus or uncontrolled type II diabetes mellitus (HbA1C ≥ 10%);
    19. Severe obesity (BMI ≥ 40 kg/m2);
    20. Arm circumference ≥ 42 cm;
    21. Atrial fibrillation;
    22. Known hypersensitivity to drugs;
    23. History of spontaneous or drug induced angioneurotic edema;
    24. Use of any medication of the following medications within the four (4) weeks prior to dosing.
    • Thyroid medication, statin therapy, oral antidiabetic drugs, estrogen replacement therapy and/or chronic low dose aspirin (75 mg/day) unless the patient has been on a stable maintenance dose for at least 3 months prior to screening.
    • Anticoagulant treatments
    • Cholestyramine resins.
    • Treatment with oral, topical, inhaled, eye drop corticosteroids
    • Treatment with class Ia, Ib and Ic or III anti-arrhythmics
    • CNS drugs
    • P-glycoprotein (P-gp) inhibitors (e.g., verapamil, quinidine, ritonavir),
    • known cytochrome P450 inducers or inhibitors (eg, ketoconazole/CYP3A4,quinidine/CYP2D6, gemfibrozil/CYP2C8)
    • Chronic use of nonsteroidal anti-inflammatory drugs (NSAIDS) or cyclooxygenase(COX)-2 inhibitors
    • Vasodilators or vascular muscle relaxants prescribed for other conditions
    25. Unlikely to cooperate in the study and/or poor compliance anticipated by the investigator,e.g., uncooperative attitude, inability to return for follow-up visit, and unlikelihood of completing the study;
    26. Participation in another interventional study at the same time or within 3 months prior to the beginning of the present study;
    27. Participant not affiliated with the French social security;
    28. No written informed consent.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint will be comparison of change from baseline of daytime mean systolic blood pressure (SBP) as calculated from the ambulatory blood pressure measurement (ABPM) after 4 weeks of treatment of QGC001 or placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout the study
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints will be comparisons between treatments (QGC001 versus placebo) on the following parameters:
    • Office SBP and diastolic blood pressure (DBP) measured at trough,
    • 24h mean SBP/DBP, daytime DBP and night-time SBP/DBP, systolic and diastolic load. The 24h systolic and diastolic loads will be calculated as the proportion of time, expressed as percentages, that the ambulatory systolic and diastolic BPs will be elevated during the daytime (> 130/80 mmHg) or during the night-time (> 120/80 mmHg).
    • The time course of the effect will be examined through home BP response every two weeks.
    • We will also use ABPM to calculate the median trough to peak ratios and their 95%CIs for QGC001.
    The pharmacokinetic endpoints will be the concentrations of QGC001 and its metabolite EC33.
    The pharmacodynamic neurohormonal endpoints will be the concentrations of plasma active renin, aldosterone, cortisol, ACTH and copeptin as well as urine aldosterone, cortisol, creatinine,apelin .
    The safety endpoints will be assessed through:
    - Adverse events,
    - Biological examinations: haematology, biochemistry (blood and urinary),
    - Physical examination with weight assessment (kg) and body temperature (°C),
    - Vital signs (supine and standing BP and HR from office measurements)
    - 12-lead ECG.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the study
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months16
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 16
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state36
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-11-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-04-13
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