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    Summary
    EudraCT Number:2009-015005-39
    Sponsor's Protocol Code Number:MW005
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-09-17
    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 number2009-015005-39
    A.3Full title of the trial
    Monocentric prospective randomized controlled open phase IV study to explorate the mechanismen of the synergetic effect of the Crateagus -Extract WS® 1442 in addition to endurance training related to quality of life of patients with limited physical potential caused by cardiovascular disease (Heart Failure Stade NYHA II)
    A.4.1Sponsor's protocol code numberMW005
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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® novo 450 film coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderDr. Willmar Schwabe GmbH & Co.
    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.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNCrateagus lavigata-Extract
    D.3.9.2Current sponsor codeWS® 1442
    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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    heart failure, stage NYHA II
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10019279
    E.1.2Term <Manually entered code. Term in E.1.1>
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1)the main objective of the study is to evaluate the physical mechanismn, which will caused by giving Crataegus-Extract WS® 1442 to patients having heart failure NYHA II, who are graduating a moderate endurance training. Those physical mechanismn will raise in addition to endurance training the quality of life
    2)to identify the parameters, which will captured the physical mechanismn definitely
    3)to verify the efficacy of Crataegus-Extract Ws 1442 with regard to life quality, physical potential and parameters, which will capture functions of the cardiopulmonary vascular and muscular systems
    4)to evaluate the compatibility
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1)male and female patients > 45 years
    2)written informed consent
    3)too little physical movement ( less than twice movements per week)
    4)history of cardiac disease, decreasing physical potential (heart failure related to NYHA II). That is heart diesease with less limitation of physical potentail, no disorders calmly, dialy physical strain causes fatique, heart rhythm disturbances, angina pectoris or dyspnea
    5)existence of at least two of the following cardiovascular riskfactors
    a)smoker
    b)waist circumference (female equal or more than 88 cm, male equal or more than
    102 cm or BMI> 30)
    c)diabetes Mellitus (blood sugar>110mg/dl or manifested diabestes mellitus
    d)arterial hypertension
    e)disorder of metabolism
    6)willing and able to complete the trial and to take part in all trial prosedures as described in the protocol
    7)female patients must ever be at least two years menopausal or have a negative serum or urin pregnancy test prior to study entry and have to use one of the following birth control methods,
    hormonal contraceptives,
    IUD,
    lifestyle with a personal choice of abstinence,
    vasectomy of sexual partner
    8)unchanged basic therapy of heart failure since 4 weeks
    9)at least one of the following underlying diseases:
    chronic coronary heart disease
    non acute non ischaemic cardiomyopathy, for example myocarditis
    arterial hypertension
    nomofrequent atrial fibrillation
    vitium Grade 1. or 2.
    condition after changing cardia velve
    10) calmly LVEF > 40%
    11) NT-pro-BNP < 450 ng/l
    12) cardiologic medicinal basic therapy according to the guidelines of the German Society of Cardiology (Hoppe et al.) and the European Society of Cardiology (Dickstein et al.) for patients with LVEF > 40%.
    Diuretics and/or Nitrate
    Betareceptorblocker and/or Verapamil to lower der heart frequence
    adequate treatment of the underlying disease(s)
    E.4Principal exclusion criteria
    1)acute and heavy heart failure within the last three months
    2)patients with pacemaker or ICD
    3)increasing worsening of the cardiology disorder within the last 7 days
    4)intake of any hawthorn compound or of any other herbal compound for heart-active compund
    5)acute or chronic psychiatric disorder
    6)history of drug allergy or hypersensitivity to drug ingredients
    7)subjects should not be enrolled as a participant in any other clinical tria within the last 4 weeks
    8)pregnant or lactating women
    9)patients positive tested for acute and heavy prohibited drugs of abuse (alcohol drugs)
    10)patients, who are planning a hospitalization during the course of the study
    11)subjects who are otherwise unsuitable for the participation in this trial in the opinion (not speaking german, acute pysical exposure, patient not able to understand the importance, consequence and the nature of the trial)
    12) treatment with heart-active glycosoide
    13)heavy or acute general disease within the last 4 weeks
    14) atrial fibrillation
    E.5 End points
    E.5.1Primary end point(s)
    quality of life, engaged by the Cansas City Cardioyopathy Questionaire (KCCQ)
    physical potential in daily life, efficiency tests during maximum of impact as well as every day stresses
    Efficiency of muscle work
    cardiac output during impact
    cardiovascular functions during impact
    oxygen supply of muscles
    unexpexted adverse events
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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) 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 Information not present in EudraCT
    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
    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 months9
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2009-09-17. Yes
    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 state140
    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 Decision2009-10-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-11-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-06-27
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