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    Summary
    EudraCT Number:2020-003005-61
    Sponsor's Protocol Code Number:BGP-15-CLIN-06
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-08-06
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2020-003005-61
    A.3Full title of the trial
    A phase 2 study on the clinical efficacy of adjuvant BGP-15 treatment additional to beta-blocker bisoprolol in patients with inappropriate sinus tachycardia
    Fázis 2, beta-blockoló melletti adjuváns BGP-15 kezelés klinikai
    hatékonyságának vizsgálata inappropiate sinus tachycardiában
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study on the clinical efficacy of adjuvant BGP-15 treatment additional to beta-blocker bisoprolol in patients with inappropriate sinus tachycardia
    Vizsgálat a BGP-15 hozzáadott szer hatásosságának megítélésére, a bisoprolol béta-blokkolóval kezelt inappropriate sinus tachycardiában szenvedő betegek esetében
    A.4.1Sponsor's protocol code numberBGP-15-CLIN-06
    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 SponsorSinusventure LLC.
    B.1.3.4CountryHungary
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSinusventure LLC.
    B.4.2CountryHungary
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSinusventure LLC.
    B.5.2Functional name of contact pointGabor Bedocs
    B.5.3 Address:
    B.5.3.1Street AddressBethlen Gabor utca 7.
    B.5.3.2Town/ cityDebrecen
    B.5.3.3Post code4026
    B.5.3.4CountryHungary
    B.5.4Telephone number3670 4543310
    B.5.6E-mailgabor.bedocs@gmail.com
    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 BGP-15
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee 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
    Inappropriate sinus tachycardia
    Inappropriate sinus tachycardia
    E.1.1.1Medical condition in easily understood language
    An abnormal increase in heart rate due to malfunction of sympathetic nervous system
    A szimpatikus idegrendszer stimulációjának következményeként bekövetkező rendellenes szívfrekvencia emelkedés
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10043083
    E.1.2Term Tachycardia sinus
    E.1.2System Organ Class 100000004849
    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 efficacy of BGP-15 administration as compared to placebo
    in patients with inappropriate sinus tachycardia (IST) receiving betablocking treatment with bisoprolol. To assess the safety and tolerability of once daily 400 mg BGP-15 administration for 4 weeks.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male and female patients diagnosed with IST, 18 years of age or
    older
    Female subjects of childbearing potential agree to undergo
    pregnancy tests and to use a medically accepted, appropriate method
    of contraception (i.e. oral contraceptive steroids, intrauterine device,
    barrier method)
    Male subjects ready to use condom to prevent a pregnancy with a
    partner of childbearing potential during the study and the following
    month
    Documented sinus tachycardia during administration of bisoprolol
    monotherapy according to the following (at least one):
    Sinus tachycardia periods with HR 100 beats/min during rest or
    after minimal physical stress
    Symptomatic mean resting HR 90 beats/min during the daytime
    hours of 24-h Holter monitoring
    Rapid stable symptomatic increase in resting HR 25 beats/min
    when moving from a supine to a standing position
    During Holter monitoring the mean HR above 100/min during alert
    state
    Patient complaints compatible with tachycardia: palpitation
    (paroxysmal or persistent) fatigue, exercise intolerance, orthostatic
    intolerance, vertigo, fainting or near fainting feeling, chest pain,
    dyspnea, anxiety
    Willingness to undergo a pre-study physical examination and preand post-study laboratory investigations
    Ability to comprehend and willingness to sign statements of
    informed consent (for the study)
    Ability, reliability and willingness to take the study compounds at the
    prescribed time points
    Taking bisoprolol (or placed on bisoprolol or at least 14 days before
    first treatment period).
    E.4Principal exclusion criteria
    Secondary sinus tachycardia (structural heart disease,
    hyperthyroidism, anaemia, infection, hypovolemia, pheochromocytoma,
    diabetes mellitus, or drug abuse)
    Paroxysmal orthostatic tachycardia syndrome (POTS)
    Any other cardiology or internal medicine disease which changes HR
    or necessitating enduring administration of cardioactive drugs, like sick
    sinus syndrome, diagnosis of orthostatic hypotension, antiarrhythmic
    therapy, renal or hepatic insufficiency
    History of, or current compulsive alcohol abuse (more than 10 drinks
    weekly); or regular exposure to other substances of abuse
    History of drug addiction, positive urine screen for drugs of abuse
    Donation or loss of blood equal to or exceeding 500 ml during 90
    days before the first administration of study medication
    Positive testing for HIV, HBsAg and HCV
    Participation in another study with an experimental drug within at
    least 30 days (or within five elimination half-lives of the previous
    experimental drug, whichever is longer) before the first administration
    of study medication
    Pregnant women (positive pregnancy test)
    Lactating women
    Unwillingness or inability to comply with the study protocol or studyrelated procedures
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study will be the proportion of subjects reaching at least 70% decrease of symptoms. The proportions obtained in the Placebo and the active treatment groups will be compared.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 28 and day 63
    E.5.2Secondary end point(s)
    Not applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    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.7.1.3.1Other 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 No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 No
    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
    20 patient completes the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    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)
    Standard of Care
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-09-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-14
    P. End of Trial
    P.End of Trial StatusOngoing
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