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    Summary
    EudraCT Number:2014-001319-38
    Sponsor's Protocol Code Number:MW051
    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:2015-08-28
    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 number2014-001319-38
    A.3Full title of the trial
    Monocenter prospective open single-arm phase IV study of the effects of hawthorn extract WS® 1442 on arterial micro-vascular structure and macro-vascular function, persistance and erectile function of male patients with underlying cardiovascular disease and erectile dysfunction
    Monozentrische prospektive offene einarmige Phase IV Studie der Effekte von Weißdorn Spezialextrakt WS® 1442 auf arterielle mikrovaskuläre Struktur und makrovaskuläre Funktion, Ausdauerleistung und Erektionsfähigkeit bei Männern mit kardiovaskulärer Grunderkrankung und erektiler Dysfunktion
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Monocenter prospective open single-arm phase IV study of the effects of hawthorn extract WS® 1442 on arterial micro-vascular structure and macro-vascular function, persistance and erectile function of male patients with underlying cardiovascular disease and erectile dysfunction
    Monozentrische prospektive offene einarmige Phase IV Studie der Effekte von Weißdorn Spezialextrakt WS® 1442 auf arterielle mikrovaskuläre Struktur und makrovaskuläre Funktion, Ausdauerleistung und Erektionsfähigkeit bei Männern mit kardiovaskulärer Grunderkrankung und erektiler Dysfunktion
    A.4.1Sponsor's protocol code numberMW051
    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 SponsorDr. Willmar Schwabe GmbH & Co. KG
    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 supportDr. Willmar Schwabe GmbH & Co. KG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDr. Willmar Schwabe GmbH & Co. KG
    B.5.2Functional name of contact pointMedical Affairs
    B.5.3 Address:
    B.5.3.1Street AddressWillmar-Schwabe Str. 4
    B.5.3.2Town/ cityKarlsruhe
    B.5.3.3Post code76227
    B.5.3.4CountryGermany
    B.5.4Telephone number00497214093 573
    B.5.5Fax number00497214093 8573
    B.5.6E-mailute.paulsen@schwabe.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 Crataegutt® 450 mg Herz-Kreislauf-Tabletten
    D.2.1.1.2Name of the Marketing Authorisation holderDr. Willmar Schwabe GmbH & CO. KG
    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 nameWS® 1442
    D.3.2Product code WS® 1442
    D.3.4Pharmaceutical form Film-coated 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 INNHawthorn leaf and flower dry extract
    D.3.9.2Current sponsor codeWS® 1442
    D.3.9.3Other descriptive nameCRATAEGUS LEAF AND FLOWER DRY EXTRACT
    D.3.9.4EV Substance CodeSUB46189
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number450
    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 Yes
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product Yes
    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
    Underlying cardiovascular disease
    Kardiovaskuläre Grunderkrankung
    E.1.1.1Medical condition in easily understood language
    Underlying cardiovascular disease
    Kardiovaskuläre Grunderkrankung
    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
    • Description of the effects of hawthorn leaf and flower dry extract WS® 1442 on arterial micro-vascular structure and macro-vascular function and laboratory parameters of cardiac stress, endothelial function, oxidative stress and inflammation.
    • Analysis of the association of these effects with the improvement of the clinical symptoms, exercise capacity and erectile function.
    • Beschreibung der Effekte von Weißdorn Spezialextrakt WS® 1442 auf die arterielle mikrovaskuläre Struktur und makrovaskuläre Funktion sowie Laborparameter zu kardialer Belastung, endothelialer Funktion, oxidativem Stress und Entzündung.
    • Analyse der Zusammenhänge dieser Effekte mit Besserungen der klinischen Symptomatik, Ausdauerleistung und Erektionsfähigkeit.
    E.2.2Secondary objectives of the trial
    Furthermore the safety and tolerability of hawthorn leaf and flower dry extract WS® 1442 in patients with underlying cardiovascular disease and erectile dysfunction will be analyzed.
    Außerdem wird die Sicherheit und Verträglichkeit von Weißdorn Spezialextrakt WS® 1442 bei Patienten mit kardiovaskulärer Grunderkrankung und erektiler Dysfunktion untersucht.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male outpatients aged 50 years and older
    2. Specialist diagnosis of underlying cardiovascular disease
    a) heart insufficiency, maximum NYHA II
    b) essential arterial hypertension or
    c) clinically manifested atherosclerosis
    3. Echocardiographic LVEF at rest ≥ 40%
    4. Basic therapy of underlying cardiovascular disease according to current guidelines
    5. Unchanged basic therapy for at least 4 weeks
    6. Erectile dysfunction (less than 22 Points in the International Index of Erectile Function)
    7. Written informed consent
    8. Willingness and ability to participate all study specific tasks
    1. Ambulante männliche Patienten 50 Jahre oder älter
    2. Fachärztliche Diagnose einer kardiovaskulären Grunderkrankung
    a) Herzinsuffizienz, maximal NYHA II
    b) Essentielle arterielle Hypertonie oder
    c) Klinisch manifeste Atherosklerose
    3. Echokardiographisch LVEF in Ruhe ≥ 40%
    4. Basistherapie der kardiovaskulären Grunderkrankung entsprechend aktueller Leitlinien
    5. Seit mindestens 4 Wochen unveränderte Basistherapie
    6. Erektile Dysfunktion (weniger als 22 Punkte für Erektionsfähigkeit im International Index of Erectile Function (IIEF))
    7. schriftliche Einwilligung nach Aufklärung
    8. Bereitschaft und Fähigkeit, an allen studienspezifischen Maßnahmen teilzunehmen
    E.4Principal exclusion criteria
    1. Unstable, severe or acute cardiovascular diseases (acute coronary syndrome, myocardial infarction, instable angina pectoris, hemodynamic valvular defect, hypertrophic obstructive cardiomyopathy, inflammatory cardiac diseases. Stroke, transient ischaemic attack, organ infarction) within the last three months
    2. Tachyarrythmic atrial fibrillation
    3. Increase of cardiovascular complaints in the last seven days
    4. Antihypertensives from more than two substance classes (ACE-Inhibitors, angiotensin II receptor antagonists, diuretics, beta-blockers, calcium antagonists, direct vasodilators, central acting antihypertensives)
    5. Treatment with digitalis
    6. Treatment with hawthorn or another herbal cardiovascular medication
    7. Treatment of erectile dysfunction
    8. Hypersensitivity towards other ingredients of the study medication
    9. Participation in other clinical trials within the last 12 weeks
    10. Ankle-brachial-index < 0,9
    11. Alcohol or drug abuse or dependence
    12. Acute or severe generalized diseases in the last 4 weeks
    13. Acute or chronic psychiatric diseases
    14. Planned hospitalization during study participation
    15. Contagious skin and venereal diseases
    16. Other factors that prevent from study participation (e.g. acute psychosocial burden, insufficient understanding of the content and scope of the study, insufficient knowledge of German language)
    1. Instabile, schwere oder akute Herz-Kreislauf-Erkrankung (akutes Koronarsyndrom, Myokardinfarkt, instabile Angina pectoris, hämodynamisch relevantes Vitium, hypertrophische obstruktive Kardiomyopathie, entzündliche Herzerkrankung. Schlaganfall, transitorische ischämische Attacke, Organinfarkt) innerhalb der letzten drei Monate
    2. Tachyarrhythmisches Vorhofflimmern
    3. Zunehmende Verschlechterung der kardiovaskulären Beschwerden in den letzten 7 Tagen
    4. Einnahme von blutdrucksenkenden Arzneimitteln aus mehr als zwei Substanzklassen (ACE-Hemmer, ATII-Antagonisten, Diuretika, Beta-Blocker, Calcium-Antagonisten, direkte Vasodilatatoren, zentral wirksame Antihypertensiva)
    5. Behandlung mit Digitalis
    6. Einnahme eines Weißdornpräparats oder eines anderen pflanzlichen Herz-Kreislauf-Präparats
    7. Einnahme von Präparaten zur Behandlung der erektilen Dysfunktion
    8. Überempfindlichkeit gegenüber einem der Inhaltsstoffe der Prüfmedikation
    9. Teilnahme an einer anderen klinischen Prüfung in den letzten vier Wochen
    10. Knöchel-Arm-Index < 0,9
    11. Alkohol- oder Drogenmissbrauch oder -abhängigkeit
    12. Schwere oder akute Allgemeinerkrankung innerhalb der letzten 4 Wochen
    13. Akute oder chronische psychiatrische Erkrankung
    14. Geplanter Krankenhausaufenthalt im Studienzeitraum
    15. Übertragbare Haut- oder Geschlechtskrankheiten, Ausschlag oder Verletzung am Penis oder dem diesen umgebenden Bereich
    16. Andere Faktoren, die die Teilnahme an der Studie in Frage stellen (z. B. akute psychosoziale Belastungen, unzureichendes Verständnis von Wesen und Tragweite der Studie, unzureichende Kenntnisse der deutschen Sprache).
    E.5 End points
    E.5.1Primary end point(s)
    Micro-Vascular structure
    - Ratio Diameter retinal arterioles/venoles
    Mikrovaskuläre Struktur
    - Verhältnis der Durchmesser retinaler Arteriolen zu Venolen
    E.5.1.1Timepoint(s) of evaluation of this end point
    after 8 weeks treatment
    nach 8 Wochen Behandlung
    E.5.2Secondary end point(s)
    Micro-vascular structure:
    - central retinal arterial equivalent (CARAE)
    - central retinal venous equivalent (CRVE)
    Macro-vascular function
    - pulse wave velocity
    - cardio-ankle vascular index
    - amplitude of the forward pulse wave
    - amplitude of the backward pulse wave
    - blood pressure
    - aortal pulse wave velocity
    - aortal pulse pressure
    - augmentation pressure
    - peripheral arterial blood pressure
    - cardiac ejection time
    exercise capacity
    - Oxygen uptake at maximum burden
    - power at maximum burden
    - increase of the pressure-rate-product and lactate from rest to 50 watt burden
    Clinical symptoms
    - sum value in the Minnesota Living with Heart Failure® Questionnaire
    Erectile function
    - sum value in the International Index of Erectile Function
    - value for erectile function in the International Index of Erectile
    - questions 2+3 in the Sexual Encounter Profile
    - measurement of the nocturnal penile tumescence
    Cardiac burden, endothelial function, oxidative stress and inflammation
    Parameter venous blood
     NT-proBNP
     ADMA
     BH4/BH2
     oxLDL/LDL
     MDA
     Plasma-F2-Isoprostane
     Nitrate/Nitrite
     hs-CRP
     IL-6
     Plasma-Microparticle
    Mikrovaskuläre Struktur
    - Zentrales retinales arterielles Äquivalent (CARAE), nicht-invasiv berührungsfrei non-mydriatisch gemessen in Ruhe mit SVA-T
    - Zentrales venöses retinales Äquivalent (CRVE), nicht-invasiv berührungsfrei non-mydriatisch gemessen in Ruhe mit SVA-T
    Makrovaskuläre Funktion
    - Parameter der arteriellen Gefäßsteifigkeit in Ruhe, nicht-invasiv gemessen
     Herz-Knöchel Pulswellengeschwindigkeit
     Cardio-Ankle Vascular Index
     Amplitude der Vorwärts-Welle (Pf)
     Amplitude der Rückwärts-Welle (Pb)
     Zentraler arterieller Blutdruck (systolisch, diastolisch, mittel)
     Aortale Pulswellengeschwindigkeit (aoPWV)
     Aortaler Pulsdruck (aoPP)
     Augmentationsdruck (AP)
     Peripherer arterieller Blutdruck (systolisch und diastolisch)
     Kardiale Ejektionszeit
    Ausdauerleistungsfähigkeit in der Fahrradspiroergometrie
    - Sauerstoffaufnahme bei maximaler Belastung (VO2peak)
    - Leistung bei maximaler Belastung
    - Anstieg des Druck-Frequenz-Produkts und des Blutlaktats zwischen Ruhe und 50 Watt Belastung
    Klinische Symptomatik
    - Summenwert im MLHQ
    Erektionsfähigkeit
    - Summenwert im IIEF
    - Wert für Erektionsfähigkeit im International Index of Erectile Function
    - Fragen 2 und 3 des Sexual Encounter Profile
    - Messung der nächtlichen penilen Tumeszenz im Schlaf mittels RigiScan® (Subgruppe)
    Kardiale Belastung, endotheliale Funktion, oxidativer Stress und Entzündung
    Parameter im venösen Blut
     NT-proBNP
     ADMA
     BH4/BH2
     oxLDL/LDL
     MDA
     Plasma-F2-Isoprostane
     Nitrat/Nitrit
     hs-CRP
     IL-6
     Plasma-Mikropartikel
    E.5.2.1Timepoint(s) of evaluation of this end point
    after 8 weeks treatment
    nach 8 Wochen Behandlung
    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 Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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
    last Patient last visit
    letzter Patient letzte Visite
    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 months36
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    F.2 Gender
    F.2.1Female No
    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 state50
    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)
    The used study drug is available in German pharmacies without prescription. Patients can continue with the treatment after the study. In case unknown physical or psychological disorders are detected during screening the site staff will inform the patients' GP. If there is no GP, the site staff will assist finding the appropriate help for the patient.
    Das verwendete Arzneimittel ist rezeptfrei in Apotheken erhältlich. Die Therapie kann zukünftig in die Therapie des Patienten integriert werden. Bei Verdacht auf bisher unbekannte oder unzureichend behandelte körperliche o. psych. Erkrankung , wird vom Prüfzentrum ein Schreiben mit genauen Angaben an den Hausarzt verfasst. Sollte der Patient keinen Hausarzt haben, leistet das Prüfzentrum Hilfestellung und Beratung bei der Findung eines geeigneten Arztes.
    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 Decision2015-09-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-24
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-09-09
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