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    Summary
    EudraCT Number:2013-005326-38
    Sponsor's Protocol Code Number:DIGIT-HF
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-11-18
    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 number2013-005326-38
    A.3Full title of the trial
    A multicenter, randomized, double-blind, placebo-controlled study to demonstrate that digitoxin reduces a composite of overall mortality and hospitalization for worsening heart failure in patients with chronic heart failure and reduced ejection fraction
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Digitoxin to improve outcomes in patients with advanced systolic chronic heart failure
    A.3.2Name or abbreviated title of the trial where available
    DIGIT-HF
    A.4.1Sponsor's protocol code numberDIGIT-HF
    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 SponsorHannover Medical School
    B.1.3.4CountryGermany
    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 supportFederal Ministry of Education and Research (BMBF)
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHannover Medical School, Department of Cardiology and Angiology
    B.5.2Functional name of contact pointProf. Dr. Udo Bavendiek
    B.5.3 Address:
    B.5.3.1Street AddressCarl-Neuberg-Str. 1
    B.5.3.2Town/ cityHannover
    B.5.3.3Post code30625
    B.5.3.4CountryGermany
    B.5.4Telephone number+495115322229
    B.5.5Fax number+495115325412
    B.5.6E-mailbavendiek.udo@mh-hannover.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 Digimerck® pico 0,05 mg
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Serono 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.3.4Pharmaceutical 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 INNDIGITOXIN
    D.3.9.1CAS number 71-63-6
    D.3.9.4EV Substance CodeSUB07133MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.05
    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.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 Yes
    D.2.1.1.1Trade name Digimerck® minor 0,07 mg
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Serono 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.3.4Pharmaceutical 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 INNDIGITOXIN
    D.3.9.1CAS number 71-63-6
    D.3.9.4EV Substance CodeSUB07133MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.07
    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.IMP: 3
    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 Digimerck® 0,1 mg Tabletten
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Serono 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.3.4Pharmaceutical 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 INNDIGITOXIN
    D.3.9.1CAS number 71-63-6
    D.3.9.4EV Substance CodeSUB07133MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.1
    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
    D.8 Placebo: 2
    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
    D.8 Placebo: 3
    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
    Advanced systolic chronic heart failure NYHA class III-IV and EF ≤ 40% or NYHA class II and EF ≤ 30%
    E.1.1.1Medical condition in easily understood language
    Advanced systolic chronic heart failure
    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 10008908
    E.1.2Term Chronic heart failure
    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 demonstrate in a large and simple clinical trial-approach that digitoxin (target serum concentrations preferably 8 - 18 ng/ml (10.5 – 23.6 nmol/l)) on top of standard of care is superior in reducing a composite of all-cause mortality and hospitalization for worsening heart failure (whichever occurs first) in patients with advanced systolic chronic heart failure (NYHA class III-IV and EF ≤ 40% or NYHA class II and ≤ 30%) to a greater extent compared to standard care plus placebo.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Sub-study 1:
    Title: The effect of digitoxin on atrial and ventricular arrhythmia
    Version of synopsis of sub-study: 1.4, 06.02.2018
    Objective: The purpose of this sub-study is to investigate the hypothesis that digitoxin therapy has no influence on the occurrence of atrial tachyarrhythmia (AT) or ventricular tachyarrhythmia (VT)

    Sub-study 2:
    Title: DIGIT-HF Sub-study: The effect of digitoxin on endothelial function in heart failure with reduced ejection fraction
    Version of synopsis of sub-study: Vs 1.3, 06.02.2018
    Objectives:
    1. To explore whether digitoxin has an effect on endothelial function
    2. To explore potential relationships among demographic and clinical factors and biomarker on endothelial function in patients with chronic heart failure
    Substudie 1:
    Titel: Effekt von Digitoxin auf die atriale und ventrikuläre Arrhythmielast
    Version der Synopse der Substudie: Vs 1.4, 06.02.2018
    Studienziel:
    Es soll in dieser Substudie die Hypothese untersucht werden, dass eine Therapie mit Digitoxin keinen Einfluss auf das Auftreten von atrialen Tachyarrhythmien (AT) oder ventrikulären Tachyarrhythmien (VT) hat
    E.3Principal inclusion criteria
    1. Signed written informed consent and willingness to comply with treatment and follow-up
    2. Male or female patients age ≥ 18 years at day of inclusion
    3. Patients capable of understanding the investigational nature, potential risks and benefits of the clinical trial
    4. Patients with chronic heart failure NYHA class III-IV and a ventricular ejection fraction of EF ≤ 40%* or patients with heart failure NYHA class II and EF ≤ 30 %*
    * determined at screening by echocardiography or cardiac magnetic resonance tomography or within 8 weeks prior to study inclusion by left-ventricular angiography, echocardiography, radionuclide ventriculography, cardiac magnetic resonance tomography
    AND
    an evidence based heart failure therapy at least for six months upon discretion of the treating physician
    5. Women without childbearing potential defined as one or more of following:
    • Women at least 6 weeks after surgical sterilization by bilateral tubal ligation or bilateral oophorectomy with or without hysterectomy at the day of inclusion
    • Women ≥ 50 years of age at the day of inclusion who have been postmenopausal since at least 1 year
    • Women < 50 years and in postmenopausal state ≥ 1 year with serum FSH > 40 IU/l (proved by a second laboratory assessment after 4 weeks)

    OR
    Women of childbearing potential who have a negative hCG pregnancy test and agree to meet one of the following criteria from the time of screening/baseline, during the study and for a period of 40 days following the last administration of study medication:
    • Correct use of reliable contraception methods. This includes hormonal contraceptive (oral contraceptives, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release) or an intrauterine device (IUD/IUS) or a barrier method of contraception such as condom or occlusive cap (diaphragm or cervical/vault caps) with spermicide (foam/gel/film/cream/suppository)
    • True abstinence (periodic abstinence and withdrawal are not acceptable methods of contraception)
    • Sexual relationship only with female partners and/or sterile male partners

    OR

    Men
    E.4Principal exclusion criteria
    1. Recent (< 2 months ago): myocardial infarction, coronary revascularization, surgery or catheter intervention for valvular heart disease, acute coronary syndrome, stroke or cerebral ischemia, start of heart failure device therapy potentially improving left ventricular ejection fraction or heart failure symptoms (e.g. cardiac resynchronization therapy (CRT), cardiac contractility modulation (CCM), baroreflex-activation therapy (BAT))
    2. Scheduled surgery or catheter intervention for valvular heart disease or scheduled coronary revascularization
    3. Active myocarditis
    4. Complex congenital heart disease; this does not include: mild-moderate valve disease, uncomplicated shunts (isolated patent foramen ovale, small atrial or ventricular septum defects without associated lesions), repaired secundum or sinus venosus atrial septal defects or ventricular septal defects without residua, previously ligated or occluded ductus arteriosus
    5. High-urgency listing for heart transplantation or scheduled therapy with left ventricular assist device (LVAD)
    6. Heart rate < 60 b.p.m. (except if functional CRT in place)
    7. SA-/AV-block > I°, sick sinus syndrome or carotis sinus syndrome (except if pace-maker protected)
    8. Proven or suspected accessory, atrio-ventricular pathways (e.g. WPW-syndrome)
    9. History of symptomatic or sustained (≥ 30 s) ventricular arrhythmia unless a cardioverter/defibrillator implanted
    10. Current ventricular tachycardia or fibrillation (this means patients presenting with a running ventricular tachycardia or fibrillation. If ventricular arrhythmias are terminated and a cardioverter/defibrillator is implanted inclusion is allowed according to point 9.)
    11. Hypertrophic obstructive cardiomyopathy (idiopathic subaortic stenosis)
    12. Cor pulmonale
    13. Constrictive pericarditis
    14. Thoracic aortic aneurysm (defined as diameter ≥ 45 mm)
    15. Concomitant severe liver and renal disease
    16. Persistent hypokalaemia (< 3.2 mM)
    17. Hypercalcemia or hypomagnesemia, if clinically suspected and verified by laboratory testing (e. g. hyperpara-thyroidism, neoplasia induced hypercalcemia, signs of neuromuscular hyperexcitability)
    18. Present (within 6 weeks before baseline/day 0 visit) and continuous treatment with Amiodarone (Single or short-term (up to 3 days), not continuous administration of amiodarone immediately before or during study treatment are acceptable)
    19. Scheduled direct current cardioversion (DCC) in the next 24 h (e. g. patients not on cardiac glycosides with new onset of atrial fibrillation. Patients already included and on treatment with IMP can continue IMP and study when scheduled for DCC)
    20. Presence of both treatment with cardiac glycosides and atrial fibrillation
    21. Simultaneous intravenous treatment with calcium salts
    22. Evidence of cardiac glycosides intolerance or known hypersensitivity to any component of investigational medicinal products
    23. Suspected intoxication with cardiac glycosides
    24. Unlikely compliance with protocol requirements
    25. Pregnant and lactating women
    26. Use of other investigational drugs or devices at the time of enrollment, or within 30 days prior to enrollment or 5 half-lives for investigational drugs, whichever is longer
    27. Life expectancy < 12 month (e.g. due to active cancer)

    E.5 End points
    E.5.1Primary end point(s)
    Composite endpoint of all-cause mortality and hospital admission for worsening heart failure (whatever occurs first)
    Admission for worsening heart failure is defined by presence of the following points together:
    1.) Worsening of heart failure based on clinical judgment (presence of heart failure symptoms) by the treating physician.
    2.) hospital stay overnight
    3.) i.v.-treatment with diuretics or vasoactive substances (e. g. nitroglycerine) or inotropes (e. g. dobutamine)
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 6, week 12, month 6 and thereafter every 6 months until end of IMP treatment at termination visit
    E.5.2Secondary end point(s)
    Key secondary endpoints:
    All-cause mortality, hospital admission for worsening heart failure, (recurrent) hospital admission for worsening heart failure

    Ohter secondary endpoints:
    Cardiovascular mortality, death from heart failure, any non-cardiovascular death, fatal or nonfatal myocardial infarction, fatal or nonfatal stroke, any cardiovascular hospitalization, hospital admission for any cause, implantation of a cardioverter-defibrillator, implantation of a cardiac-resynchronisation device, implantation of a pacemaker, sudden cardiac death, change in functional capacity assessed by NYHA class.
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 6, week 12, month 6 and thereafter every 6 months until end of IMP treatment at termination visit
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned44
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA47
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    Serbia
    E.8.7Trial has a data monitoring committee Yes
    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
    LVLP
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months1
    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: 438
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1752
    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 state2130
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 2190
    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 (normal treatment of that condition)
    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 Decision2015-03-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-10
    P. End of Trial
    P.End of Trial StatusOngoing
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