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    The EU Clinical Trials Register currently displays   43872   clinical trials with a EudraCT protocol, of which   7291   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2016-004600-53
    Sponsor's Protocol Code Number:RBK03-16-00389
    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:2017-06-19
    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 ConcernedGermany - BfArM
    A.2EudraCT number2016-004600-53
    A.3Full title of the trial
    MACH 2 - Magnesium orotate in severe congestive heart failure - Part 2
    Wirksamkeit von Magnesium-Orotat bei Patienten mit HFrEF in Bezug auf den Einfluss von NTproBNP - eine prospektive, monozentrische, randomisierte, doppelblinde, placebo-kontrollierte Cross-over Studie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Investigation of effects of Magnesium orotate on cardiac marker in patients with severe congestive heart failure.
    Studie zur Untersuchung des Einflusses von Magnesium-Orotat auf bestimmte Marker im Blut bei Patienten mit Herzschwäche
    A.3.2Name or abbreviated title of the trial where available
    MACH2
    A.4.1Sponsor's protocol code numberRBK03-16-00389
    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 SponsorWÖRWAG Pharma 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 supportWÖRWAG Pharma GmbH & Co. KG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationWÖRWAG Pharma GmbH & Co. KG
    B.5.2Functional name of contact pointProject manager
    B.5.3 Address:
    B.5.3.1Street AddressFlugfeld-Allee 24
    B.5.3.2Town/ cityBöblingen
    B.5.3.3Post code71034
    B.5.3.4CountryGermany
    B.5.4Telephone number004907316204416
    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 Magnerot Classic N
    D.2.1.1.2Name of the Marketing Authorisation holderWörwag Pharma 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 nameMagnesiumorotat-Dihydrate
    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 INNMAGNESIUM OROTATE-DIHYDRATE
    D.3.9.1CAS number 34717-03-8
    D.3.9.3Other descriptive nameMAGNESIUM OROTATE-DIHYDRATE
    D.3.9.4EV Substance CodeSUB117638
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 placeboTablet
    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
    Heart failure with reduced ejection fraction
    Herzinsuffizienz mit eingeschränkter Pumpfunktion
    E.1.1.1Medical condition in easily understood language
    Weakness of the heart
    Herzschwäche
    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 10019284
    E.1.2Term Heart failure, congestive
    E.1.2System Organ Class 100000004849
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10064081
    E.1.2Term Heart failure NYHA class III
    E.1.2System Organ Class 100000004849
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10064080
    E.1.2Term Heart failure NYHA class II
    E.1.2System Organ Class 100000004849
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10064082
    E.1.2Term Heart failure NYHA class IV
    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
    The aim of the study is to show that a significant reduction of NTproBNP can be achieved by the regular intake of magnesium orotate compared to placebo.
    Studienziel ist es zu zeigen, dass eine signifikante Absenkung des NTproBNP durch die regelmäßige Einnahme von Magnesium-Orotat im Vergleich zu Placebo erzielt werden kann.
    E.2.2Secondary objectives of the trial
    In addition, it is to be shown that magnesium orotate is superior to placebo over
    • Improve the symptoms of heart failure (weight, edema)
    • Improve the NYHA classification
    • Increase in LVEF
    • Improvement of symptoms as measured by the KCCQ questionnaire (Faller et al., 2005)
    • Reduction of hospitalization rate due to cardiac insufficiency, cardiac decompensation or myocardial infarction
    • Improve the patient's subjective quality of life as measured by EQ-5D-5L
    Darüber hinaus soll gezeigt werden, dass Magnesium-Orotat gegenüber Placebo überlegen ist hinsichtlich
    • Verbesserung der Symptome der Herzinsuffizienz (Gewicht, Ödeme)
    • Verbesserung der NYHA-Klassifizierung
    • Steigerung der LVEF
    • Verbesserung der Symptome, gemessen an Hand des KCCQ-Fragebogens (Faller et al., 2005)
    • Verringerung der Hospitalisierungsrate aufgrund Herzinsuffizienz, kardialer Dekompensation oder Herzinfarkt
    • Verbesserung der subjektiven Lebensqualität des Patienten, gemessen nach EQ-5D-5L
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patients ≥ 18 years
    2. Patients with chronic heart failure who have been treated continuously for at least 3 months according to current guidelines
    3. NYHA Class II-IV
    4. LVEF < 45%
    5. NTproBNP >= 600 pg / ml (most recent value in the last 3 months)
    6. Willingness to abstain from consuming alcohol during the study period
    7. Existence of written consent
    1. Männliche oder weibliche Patienten ≥ 18 Jahre
    2. Patienten mit chronischer Herzinsuffizienz, die seit mindestens 3 Monaten kontinuierlich nach den aktuellen Leitlinien behandelt werden
    3. NYHA Klasse II-IV
    4. LVEF < 45%
    5. NTproBNP >= 600 pg/ml (aktuellster Wert in den letzten 3 Monaten)
    6. Bereitschaft, während der Studienteilnahme auf den Konsum von Alkohol zu verzich-ten
    7. Vorliegen der schriftlichen Einverständniserklärung
    E.4Principal exclusion criteria
    1. LVEF ≥ 45%
    2. NTproBNP < 600 pg / ml
    3. Known hypersensitivity to magnesium or any of the other ingredients of the test medication
    4. Currently decompensated heart failure
    5. Severe renal impairment
    6. GFR <30 ml / min / 1.73 m2
    7. Acute coronary syndrome in the last 3 months before inclusion
    8. Myasthenia gravis
    9. Known AV block grade 2 or 3
    10. Existing or planned pregnancy or women who breastfeed
    11. Patients who had an organ transplant
    12. Patients who have a LVAD
    13. Hb <8 g /dl
    14. AST / ALT> 3 x ULN
    15. Stroke / TIA in the last 3 months
    16. Heart failure in the last 3 months
    17. Cancer disease or treatment in the last 5 years
    18. Tuberculosis, hepatitis, HIV infection or other serious viral diseases
    19. Depressive illnesses with suicidal thoughts or suicide attempt (s) in the anamnesis
    20. Severe mitral or aortic valve disease
    21.Myocarditis, valvular cardiomyopathy, Tako-Tsubo-cardiomyopathy or peripartal cardiomyopathy
    22. Existence of diseases with a life expectancy <1 year
    23. Any clinical finding which, in the opinion of the investigator, affects participation in the study
    24. Dependency relationship with the sponsor or the study staff
    25. Simultaneous participation in other clinical trials or registries
    26. Ingestion of magnesium orotate in the past 12 months
    27. Ingestion of other magnesium compounds in the last 4 weeks
    28. Patients who are not expected to adhere to the guidelines in the study protocol (lack of compliance)
    1. LVEF ≥ 45%
    2. NTproBNP < 600 pg/ml
    3. Bekannte Überempfindlichkeit gegen Magnesium oder einen der anderen Inhaltsstoffe der Prüfmedikation
    4. Aktuell dekompensierte Herzinsuffizienz
    5. schwere Nierenfunktionsstörungen
    6. GFR < 30 ml/min/1,73m2
    7. Akutes Koronarsyndrom in den letzten 3 Monaten vor Einschluss
    8. Myasthenia gravis
    9. Bekannter AV-Blockgrad 2 oder 3
    10. Bestehende oder geplante Schwangerschaft oder Frauen, die stillen
    11. Patienten, die eine Organtransplantation hatten
    12. Patienten, die einen LVAD haben
    13. Hb < 8 g/dl
    14. AST/ALT > 3 x ULN
    15. Schlaganfall/TIA in den letzten 3 Monaten
    16. Herzstillstand in den letzten 3 Monaten
    17. Krebserkrankung oder -behandlung in den letzten 5 Jahren
    18. Tuberkulose, Hepatitis, HIV-Infektion oder andere schwere Virus-Erkrankungen
    19. Depressive Erkrankungen mit suizidalen Gedanken oder Suizidversuch(en) in der Anamnese
    20. Schwere Mitral- oder Aortenklappenerkrankung
    21.Myokarditis, valvuläre Kardiomyopathie, Tako-Tsubo-Kardiomyopathie oder peripartale Kardiomyopathie
    22. Vorliegen von Erkrankungen mit einer Lebenserwartung < 1 Jahr
    23. Jeglicher klinischer Befund, der nach Ansicht des Prüfarztes eine Teilnahme an der Studie beeinträchtigt
    24. Abhängigkeitsverhältnis zum Sponsor oder dem Studienpersonal
    25. Gleichzeitige Teilnahme an anderen klinischen Studien oder Registern
    26. Einnahme von Magnesium-Orotat in den letzten 12 Monaten
    27. Einnahme anderer Magnesiumverbindungen in den letzten 4 Wochen
    28. Patienten, die sich voraussichtlich nicht an die Vorgaben im Studienprotokoll halten (fehlende Compliance)
    E.5 End points
    E.5.1Primary end point(s)
    Measurement of NTproBNP
    Messung des NtproBNP
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, Week 4, Week 12, Week 20, Week 24, Week 32 (EoS)
    Bei Beginn der Studie, Woche 4, Woche 12, Woche 20, Woche 24, Woche 32 (Studienende)
    E.5.2Secondary end point(s)
    Patient questionnaires, NYHA-classification, echocardiogram
    Patienten Fragebögen, NYHA-Klassifizierung, Echokardiogramm
    E.5.2.1Timepoint(s) of evaluation of this end point
    Patient questionnaires and echocardiogram: Baseline, Week 12, Week 20, Week 32 (EoS)
    NYHA-classification: Baseline, Week 4, Week 12, Week 20, Week 24, Week 32 (EoS)
    Patienten Fragebögen und Echokardiogramm: Bei Beginn der Studie, Woche 12, Woche 20, Woche 32 (Studienende)
    NYHA-Klassifizierung: Bei Beginn der Studie, Woche 4, Woche 12, Woche 20, Woche 24, Woche 32 (Studienende)
    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 No
    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 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 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 Studienvisite des letzten Patienten
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months3
    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: 10
    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 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 state30
    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
    keine
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation medistat GmbH
    G.4.3.4Network Country Germany
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-06-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-09-04
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