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    Summary
    EudraCT Number:2012-005097-66
    Sponsor's Protocol Code Number:NCAG2512
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-03-19
    Trial results View 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 ConcernedGermany - BfArM
    A.2EudraCT number2012-005097-66
    A.3Full title of the trial
    Effect of two homeopathic preparations on blood pressure in comparison to metoprolol (trade name Beloc-Zok® mite 47,5 mg) in 90 patients suffering from mild hypertonia. A prospective, confirmatory, open, randomized controlled, 3-armed, repetitive study over 6 weeks in parallel design.
    Nachweis der Blutdruck-senkenden Wirkung zweier homöopathischer Komplexmittel im Vergleich zu Metoprolol (Handelsname Beloc-Zok® mite 47,5 mg) an 90 Patienten mit leichter Hypertonie. Eine prospektive, konfirmatorische, offene, randomisiert kontrollierte, 3-armige, repetitive Studie über 6 Wochen im parallel-Design.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of two homeopathic preparations on blood pressure in comparison to metoprolol (trade name Beloc-Zok® mite 47,5 mg) in 90 patients suffering from mild hypertonia. A prospective, confirmatory, open, randomized controlled, 3-armed, repetitive study over 6 weeks in parallel design
    Nachweis der Blutdruck-senkenden Wirkung zweier homöopathischer Komplexmittel im Vergleich zu Metoprolol (Handelsname Beloc-Zok® mite 47,5 mg) an 90 Patienten mit leichter Hypertonie. Eine prospektive, konfirmatorische, offene, randomisiert kontrollierte, 3-armige, repetitive Studie über 6 Wochen im parallel-Design.
    A.4.1Sponsor's protocol code numberNCAG2512
    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 SponsorHOMVIORA Arzneimittel - Dr. Hagedorn GmbH & Co.
    B.1.3.4CountryGermany
    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 supportHOMVIORA Arzneimittel - Dr. Hagedorn GmbH & Co.
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHOMVIORA Arzneimittel - Dr. Hagedorn GmbH & Co.
    B.5.2Functional name of contact pointDr. med. Violetta Horn
    B.5.3 Address:
    B.5.3.1Street AddressArabellastraße 5
    B.5.3.2Town/ cityMünchen
    B.5.3.3Post codeD-81925
    B.5.3.4CountryGermany
    B.5.4Telephone number00498992199430
    B.5.5Fax number004989917985
    B.5.6E-mailvhorn@homviora.de
    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 Yes
    D.2.1.1.1Trade name Homviotensin® Tabletten
    D.2.1.1.2Name of the Marketing Authorisation holderHomviora Arzneimittel, Dr. Hagedorn GmbH & Co.
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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.3.1Product nameHomviotensin® Tabletten
    D.3.4Pharmaceutical form Tablet
    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.3.8INN - Proposed INNReserpinum Trit. D3
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number32
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRauwolfia serpentina Trit. D3
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number32
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNViscum album Trit. D2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number32
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCrataegus Trit. D2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number64
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    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.3.1Product nameHomvioalbin® Tabletten
    D.3.4Pharmaceutical form Tablet
    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.3.8INN - Proposed INNReserpinum Trit. D5
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number32
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRauwolfia serpentina Trit. D3
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number32
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNViscum album Trit. D2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number32
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCrataegus Trit . D2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number64
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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) Yes
    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 Yes
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Beloc-Zok® mite 47,5 mg Retardtabletten
    D.2.1.1.2Name of the Marketing Authorisation holderAstra Zeneca GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.1Product nameBeloc-Zok® mite 47,5 mg Retardtabletten
    D.3.4Pharmaceutical form Prolonged-release tablet
    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.3.8INN - Proposed INNMetoprololsuccinat 47,5 mg
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number47,5
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients suffering from mild hypertonia
    Patienten, die unter einer leichten Hypertonie leiden
    E.1.1.1Medical condition in easily understood language
    Patients suffering from mild hypertonia
    Patienten, die unter einer leichten Hypertonie leiden
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Both homeopathic preparations (Verum 1 and 2) will be tested in comparison to a standard therapy (Beloc-Zok® mite 47,5 mg = Verum 3) in patients with mild hypertonia. Equitherapeutical effect will be tested.
    With respect to Verum 1 and Verum 2 increase of cognitive efficacy and lack of sedation will be tested using quantitative EEG.
    Primary target (blood pressure =RR): 1 (confirmatory analysis: ITT between baseline and last administration after 6 weeks).
    Beide homöopathische Komplexmittel (Verum 1 und 2) sollen im Vergleich zu einer Standardtherapie (Beloc-Zok® mite 47,5 mg = Verum 3) an Patienten mit leichtem Bluthochdruck auf äquitherapeutische Wirksamkeit geprüft werden.
    Für Verum 1 und Verum 2 soll die vermutete kognitive Leistungssteigerung und das Fehlen einer sedierenden Wirkung mittels qEEG gezeigt werden.
    Primäre Zielgröße (Blutdruck = RR): 1 (konfirmatorische Analyse: ITT zwischen dem Vorwert und der letzten Gabe nach 6 Wochen kontinuierlicher Einnahme).
    E.2.2Secondary objectives of the trial
    Quantitative EEG: Enhancement of spectral theta power of the EEG as indicator of wakefulness and tiredness (sedation). Comparison of Verum 2 vs. Verum 3 at baseline with final administration after 6 weeks of repetitive intake.
    quantitative EEG: Check of cognitive efficacy by means of a combination of psychometry and concomitant EEG recording (Comparison Verum 2 vs. Verum 3) at baseline with final administration after 6 weeks of repetitive intake.
    Quantitatives EEG: Erhöhung der spektralen theta-Leistung im qEEG als Indikator von Wachheit bzw. aufkommender Müdigkeit (Sedierung). (Vergleich: Verum2 vs. Verum3).
    quantitatives EEG: Überprüfung der kognitiven Leistungsfähigkeit mittels Kombination von Psychometrie und parallel abgeleitetem qEEG (Vergleich: Verum2 vs. Verum3).(Tag A – Tag C)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male or female patients.
    Patients with mild hypertension (grade 1)= systolic 140-159 mmHg / = diastolic 90-99 mmHg. / on day SC and day A.
    Age 40 to 70 years (both inclusive extremes).
    The patient must be capable of giving consent
    Written and signed informed consent in accordance with the legal requirement.
    Primäre, essentielle arterielle Hypertonie (140-159 mmHg / 90-99 mmHg) bei Männern und Frauen zwischen 40 und 70 Jahren mit weniger als drei Risikofaktoren entsprechend Stratification of Risk to Quantify Prognosis, 1999 WHO. Als Risikofaktoren gelten u. a. unbehandelte Hypercholesterinämie (Ges. –Chol.> 250 mg/dl), Diabetes mellitus, Nikotinabusus, durchgemachte Folgeerkrankungen (< 6 Monate zurück – siehe auch Ausschlusskriterien) und positive Familienanamnese.

    Männliche und weibliche Patienten.
    Patienten mit leichtem Hochdruck (Grad 1)= systolisch 140-159 mmHg / = diastolisch 90-99 mmHg. / gemessen am Tag SC und am Tag A.
    Alter 40 - 70 Jahre (jeweils einschließlich).
    Der Patient muss einwilligungsfähig sein
    Vorlage der vom Patienten unterschriebenen Einverständniserklärung (schriftliche Zustimmung (Unterschrift "informed consent", und der unterschriebenen Datenschutzerklärung.
    E.4Principal exclusion criteria
    Excluded patients with moderate (grade 2 = 160-179 mm Hg systolic / diastolic 100-109 mmHg) to high (grade 3 = systolic > 189 mmHg / > 110 mmHg diastolic ) blood pressure (WHO and British Hypertension Society Guideline)

    Medication of antihypertensive drugs in the last 14 days prior to day A or additional intake of antihypertensive drugs (except for the study medication) during test days between day A+1 and day C.
    Clinically study-related acute or chronic diseases, which are reported or were clinically filed.
    Clinically relevant abnormal findings from clinical and laboratory investigators.
    Clinically relevant pathological EEG findings (e.g. artifact-free parts in screening EEG <30% in one recording).
    Clinically relevant allergies.
    Positive alcohol testing on Screening and the day A, B and C
    Positive drug screening test on Screening and day SC.
    Intake of study relevant medication 14 days prior to active day SC , or during active study duration, based on the patient´s information.
    Regular intake of drugs with primary central nervous effects (e.g. psychoactive drugs or centrally acting antihypertensive drugs).
    Participation in another clinical trial within the last 60 days.
    Known intolerance / hypersensitivity/ (allergy) to herbal extracts (i.e. dry extract of Reserpinum, Rauwolfia serpentina, Viscum album, Crataegus and lactose monohydrate), where a history exists for any of the ingredients or ingredients of the investigational product.
    Abuse of coffee, tea or tobacco.
    Smoking in the investigational site on the day A, B,C / smoking of more than 10 cigarettes / day.
    Positive Pregnancy Test (day SC/B).
    Lactation.
    Bad Compliance.
    Revocation of informed consent.
    Ausschlusskriterien
    Ausgeschlossen werden Patienten mit moderatem (Grad 2 = systolisch 160-179 mmHg / diastolisch 100-109 mmHg) bis hohem (Grad 3= systolisch >189 mmHg / > diastolisch 110 mmHg) Blutdruck (WHO bzw. British Hypertension Society Guideline)

    Gegenanzeigen Homviotensin:
    bei Überempfindlichkeit gegen einen der Bestandteile von Homviotensin

    Gegenanzeigen Homvioalbin:
    bei Überempfindlichkeit gegen einen der Bestandteile von Homvioalbin

    Gegenanzeigen Beloc-Zok mite 47,5 mg

    Weiterhin darf Metoprololsuccinat nicht angewendet werden bei:
    - AV-Block II. und III. Grades,
    - Sick-Sinus-Syndrom,
    - höhergradigen SA-Blockierungen,
    - Schock,
    - Bradykardie mit einer Herzfrequenz <50 Schlägen/min in Ruhe vor der Behandlung,
    - Spätstadium peripherer Durchblutungsstörungen,
    - bronchialer Hyperreagibilität,
    - gleichzeitiger Gabe von Monoaminooxidase (MAO)-Hemmstoffen (Ausnahme MAO-B-Hemmstoffe).

    Metoprololsuccinat darf außerdem nicht angewendet werden bei chronisch herzinsuffizienten Patienten mit:
    - instabiler, dekompensierter Herzinsuffienz (Lungenödemen, Hypoperfusion oder Hypertension)
    - kontinuierlicher oder intermittierender Behandlung mit positiv inotrop wirkenden Betasympathomimetika
    - einer Herzfrequenz <68 Schlägen/min. in Ruhe vor Behandlung
    - wiederholt erniedrigtem Blutdruck unter 100 mmHg (erneute Untersuchung vor Behandlungsbeginn notwendig).

    Allgemeine Gegenanzeigen:
    • Teilnahme an anderer Studie innerhalb der letzten 60 Tage
    • konsumierende Erkrankungen
    • mehr als zwei der genannten Risikoerkrankungen
    • Schwangerschaft und Stillzeit
    • mangelnde Compliance

    weitere Ausschlusskriterien:
    Herz-Kreislauf-System
    sekundärer Hypertonus
    fortgeschrittene hypertensive Retinopathie (Stad.3 oder 4)
    Herzinsuffizienz (NYHA )
    Linksherzhypertonie
    derzeitige Angina pectoris (nach klinischen Kriterien)
    Z. n. Mykardinfarkt (<6 Monate zurückliegend)
    Z. n. koron. Revaskularisation (PTCA, Stent, ACB-OP <6 Monate zurück)
    Z. n. TIA, apoplekt. Insult, cerebraler Haemorrhagie (<6 Monate zurück)

    Niere
    Proteinurie (>0,3 g/24h) bzw. einfach-pos. (+) per Stix
    manifeste Niereninsuffizienz (Kreatin > 2,0 mg/dl)

    Endokrinologie
    Diabetes mellitus (Typ I oder II) diätisch und/oder medikamentös einstellbar sowie pathologischer Glucosetoleranztest (OGT)
    Hyperthyreose (ZSH basal < 0,26 µE/ml)


    weitere Ausschlusskriterien
    Ausgeschlossen werden Patienten, die in der Auswaschphase die festgelegten Werte die leichten Bluthochdruck Grad 1 (systolisch 140-159 mmHg / diastolisch 90-99 mmHg) überschreiten.
    • Medikamenteneinnahme von blutdrucksenkenden Präparaten in den letzten 14 Tagen vor Tag A bzw. zusätzliche Einnahme von blutdrucksenkenden Präparate (außer der Prüfmedikation)

    zwischen Prüftagen Tag A, B und C
    • Klinisch studienrelevante akute oder chronische Erkrankungen, die durch Anamnese oder klinische Untersuchungen erhoben werden/wurden.
    • Klinisch relevanter pathologischer Befund aus klinischen und laborchemischen Untersuchungen (Prüfarzt entscheidet).
    • Klinisch relevante Allergien.
    • Nachweis von Alkohol zum Zeitpunkt der Aufnahmeuntersuchung (Tag SC) sowie am Untersuchungstag A , B und C (positiver Alkoholtest) bzw. anamnestisch erfragt.
    • Nachweis von Drogen (positiver Drogentest) am Tag SC.
    Einnahme klinisch relevanter Medikation in den letzten vierzehn Tagen vor sowie während der aktiven Studienphase basierend auf der Mitteilung des Patienten oder der erhobenen Anamnese.
    Dauereinnahme von Medikamenten mit primär zentralnervösem Angriff (z.B. Psychopharmaka oder zentral angreifende Antihypertensiva).
    Teilnahme an einer anderen klinischen Studie innerhalb der letzten 60 Tage.
    Bekannte Unverträglichkeit/Überempfindlichkeit (Allergien) gegen pflanzliche Extrakte (Reserpinum, Rauwolfia serpentina, Viscum album, Crataegus und Lactose-Monohydrat), soweit anamnestisch oder per Befund - oder einen der sonstigen Bestandteile bzw. Inhaltsstoffe der Prüfpräparate.
    Konsum unüblicher Mengen resp. Missbrauch von Kaffee, Tee oder Tabak.
    Rauchen im Prüfzentrum am Tag A ,B und C / Rauchen im Mittel >10 Zigaretten/Tag
    Positiver Schwangerschaftstest (Tag SC und B).
    Stillzeit.
    Mangelhafte Compliance.
    Widerruf der Einverständniserklärung.
    E.5 End points
    E.5.1Primary end point(s)
    Six weeks after start of the medication.
    nach 6 Wochen Einnahme.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Six weeks after start of the medication.
    nach 6 Wochen Einnahme.
    E.5.2Secondary end point(s)
    Six weeks after start of the medication.
    nach 6 Wochen Einnahme.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Six weeks after start of the medication.
    nach 6 Wochen Einnahme.
    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 Yes
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    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 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Beloc-Zok ® mite 47,5 mg
    Beloc-Zok® mite 47,5 mg
    E.8.2.4Number of treatment arms in the trial3
    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
    LVLS
    Letzte Visite des letzten Patienten
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months4
    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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 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 state90
    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)
    None: As patients are enrolled in the study, no treatment or care is planned after the last visit of a subject.
    In case of pretermination, it is planned to make a clinical examination to document the patient´s condition.
    In case of serious adverse drug reactions, that did not recover within study duration, the subject will be observed until full recovery or another statisfying conclusion is found.
    Keine
    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 Decision2014-07-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2016-11-07
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