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    Summary
    EudraCT Number:2014-005567-33
    Sponsor's Protocol Code Number:MEIN/14/FEB-PWV/001
    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:2015-05-19
    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 number2014-005567-33
    A.3Full title of the trial
    The Effect of Intensive Urate Lowering Therapy (ULT) with Febuxostat in Comparison with Allopurinol on Cardiovascular Risk in Patients with Gout Using Surrogate Markers: a Randomized, Controlled Trial (Acronym: the FORWARD Trial)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of intensive urate lowering therapy (ULT) with febuxostat in comparison with allopurinol on cardiovascular risk in patients with gout (short title: the FORWARD trial)
    A.3.2Name or abbreviated title of the trial where available
    FORWARD trial
    A.4.1Sponsor's protocol code numberMEIN/14/FEB-PWV/001
    A.5.4Other Identifiers
    Name:the FORWARD trialNumber:MEIN/14/FEB-PWV/001
    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 SponsorMenarini International Operations Luxembourg S.A.
    B.1.3.4CountryLuxembourg
    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 supportMenarini
    B.4.2CountryLuxembourg
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMenarini
    B.5.2Functional name of contact pointPaolo Fabrizzi
    B.5.3 Address:
    B.5.3.1Street AddressVia Sette Santi, 1
    B.5.3.2Town/ cityFirenze
    B.5.3.3Post code50131
    B.5.3.4CountryItaly
    B.5.4Telephone number+390555680459
    B.5.5Fax number+3905556809961
    B.5.6E-mailPFabrizzi@menarini.it
    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 ADENURIC®
    D.2.1.1.2Name of the Marketing Authorisation holderMenarini International Operations Luxembourg S.A.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 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 INNFEBUXOSTAT
    D.3.9.1CAS number 144060-53-7
    D.3.9.4EV Substance CodeSUB25382
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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 ADENURIC®
    D.2.1.1.2Name of the Marketing Authorisation holderMenarini International Operations Luxembourg S.A.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 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 INNFEBUXOSTAT
    D.3.9.1CAS number 144060-53-7
    D.3.9.4EV Substance CodeSUB25382
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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 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 Allopurinol Teva Italia 100 mg Tablets
    D.2.1.1.2Name of the Marketing Authorisation holderTeva Italia S.r.l.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 INNALLOPURINOL
    D.3.9.3Other descriptive nameAllopurinol
    D.3.9.4EV Substance CodeSUB05338MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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: 4
    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 Allopurinol Teva Italia 300 mg
    D.2.1.1.2Name of the Marketing Authorisation holderTeva Italia S.r.l.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 INNALLOPURINOL
    D.3.9.3Other descriptive nameAllopurinol
    D.3.9.4EV Substance CodeSUB05338MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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
    Gout
    E.1.1.1Medical condition in easily understood language
    Gout
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10018627
    E.1.2Term Gout
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Pulse Wave Velocity
    E.2.2Secondary objectives of the trial
    • Pulse Wave Analysis
    • Brain natriuretic peptide and in N-terminal prohormone of brain natriuretic peptide (BNP and NTproBNP)
    • Markers of inflammation (hsCRP, TNF-α, plasma fibrinogen)
    • Markers of endothelial activation (sVCAM, sICAM, vWF, e-selectine)
    • Oxidative stress parameters: MDA, MPO, Ox-LDL, PON1 and PON2
    • sUA, eGFR, Serum creatinine and urine albumin to creatinine ratio
    • Lipid profile
    • Safety and tolerability
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patients 18 years and older;
    2. History of gout, flare free in the 4 weeks prior to study entry
    3. History of crystal (joint liquid) proven diagnosis or anamnestic diagnosis of gout according to Wallace et al. To be eligible a subjects has to present at least 6 out of the twelve clinical, laboratory, and X-ray phenomena listed below:
    1. Maximum inflammation developed
    within 1 day
    2. More than one attack of acute arthritis
    3. Monoarticular arthritis attack
    4. Redness observed over joints
    5. First metatarsophalangeal (MTP) pain or
    swelling
    6. Unilateral first MTP joint attack
    7. Unilateral tarsal joint attack
    8. Suspected or proven tophus
    9. Hyperuricemia
    10. Asymmetric swelling within a joint on
    a X-ray
    11. Subcortical cysts without erosions on
    X-ray
    12. Negative organisms on culture of joint
    fluid

    4. Naive to ULT or previously treated with ULT, but with no ULT treatment in the last 1 month prior to study entry and only if reason for ULT interruption was not due to safety concerns.
    5. Patients at study entry have elevated serum urate level> 8 mg/dl.
    6. Overall CV risk based on the scoring proposed by the Joint Task Force of the European Society of Cardiology and other European Societies on cardiovascular disease prevention in clinical practice between 5 and 15% (inclusive) as per protocol appendix 2. Patients with diabetes mellitus type 2 could be included in the study if their CV risk score is calculated as ≤7%.
    7. Allowed concomitant medications should be maintained stable during the last 2 weeks before randomization
    E.4Principal exclusion criteria
    1. Severe chronic renal failure (creatinine clearance < 30 ml/min)
    2. Hepatic failure
    3. Active liver disease or hepatic dysfunction, defined as both ALT and AST >2 times the upper limit of normal.
    4. Diabetes mellitus type1
    5. Life-threatening co-morbidity or with a significant medical condition and/or conditions that would interfere with the treatment, the safety or the compliance with the protocol
    6. Diagnosis of, or receiving treatment for malignancy (excluding basalioma skin cancer) in the previous 5 years
    7. Patients who have experienced either myocardial infarction or stroke
    8. Patients with inflammatory based arthritis (e.g.: rheumatoid arthritis, etc.)
    9. Patients with congestive heart failure, New York Heart Association (NYHA) Class III or IV
    10. Patients with untreated/uncontrolled thyroid function
    11. Patients with clinically severe peripheral arterial disease
    12. Concomitant administration of one of the following: azathioprine, mercaptopurine, theophylline, meclofenamate, sulfinpyrazone, trimethoprim-sulfamethoxazole, cyclophosphamide, benzbromarone, pyrazinamide, captopril and enalapril (for Allopurinol), tegafur, pegloticase and tacrolimus.
    13. Hypersensitivity to any of the active substance or to any of the excipients
    14. Any contraindication to febuxostat or allopurinol (with reference to the summary of product characteristics).
    15. Subject is unable to take either of the protocol-required gout flare prophylactic medications (NSAID or colchicine) due to contraindications or intolerance, e.g. hypersensitivity, active gastric ulcer disease, renal impairment and/or changes in liver enzymes
    16. Participation in another trial of an investigational drug or device within 30 days prior to screening, or prior treatment with investigational product(s)
    17. Women of childbearing potential (WOCBP), including perimenopausal women who have had a menstrual period within 1 year, not willing to use highly effective method of birth control throughout the study period and for 4 weeks after study completion (defined as a method which results in a failure rate of less than 1% per year) such as:
    - combined (estrogen and progestogen containing) hormonal
    contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)
    - progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
    - intrauterine device (IUD)
    - intrauterine hormone-releasing system (IUS)
    - bilateral tubal occlusion
    - vasectomised partner (provided that partner is the sole sexual partner of the trial participant and that the vasectomised partner has received medical assessment of the surgical success)
    - sexual abstinence
    In each case of delayed menstrual period (over one month between menstruations) absence of pregnancy has to be confirmed. This also applies to WOCBP with infrequent or irregular menstrual cycles.
    18. Severe psychiatric disorders/neurological disorders
    19. Severe concurrent pathology, including terminal illness (cancer, AIDS, etc)
    20. Abuse of alcohol, analgesics, or psychotropic drugs
    21. Inability or unwillingness, in the investigator's opinion, to follow study procedures, including, but not limiting to ability to obtain adequate PWV/PWA recordings. Special attention should be paid to any physical abnormalities which could affect quality of PWV/PWA measurement:
    • Neck region- flexibility of the neck and accessibility of carotid artery,
    • Upper arm and thigh region- exclude any abnormality which would
    prevent adequate placement of the cuff
    22. Inability or unwillingness to issue the informed consent
    E.5 End points
    E.5.1Primary end point(s)
    Comparison of the effects of febuxostat and allopurinol on Pulse Wave Velocity (PWV) after 36 weeks of treatment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    after 36 weeks of treatment
    E.5.2Secondary end point(s)
    • Changes in BNP and NTproBNP values after 12, 24 and 36 weeks of treatment;
    • Changes in inflammation markers (hsCRP, TNF-α, sUA, and plasma fibrinogen) after 12, 24 and 36 weeks of treatment;
    • Changes in oxidative stress parameters [Malondialdehyde (MDA), Myeloperoxidase (MPO) Oxidized low-density lipoprotein (Ox-LDL), Paraoxonase 1 and 2 (PON1, PON2)] after 12, 24 and 36 weeks of treatment;
    • Changes in lipid profile after 12, 24 and 36 weeks of treatment;
    • Percentage of gout patients with a serum urate concentration of less than, or equal to 6 mg/dl after 12, 24 and 36 weeks of treatment.
    • Time to achieve sUA target levels for patients stratified for sUA levels at baseline as follows: 8.1-8.8 mg/dl, 8.9-9.6 mg/dl, 9.7-10.3 mg/dl, 10.4-11.0 mg/dl, >11 mg/dl.
    • Changes in eGFR with CKD-EPI formula after 12, 24 and 36 weeks of treatment;
    • Changes in urine albumin excretion as evaluated by first morning urine albumin/creatinine ratio (mg/g) after 12, 24 and 36 weeks of treatment;
    • Percentage of patients above the sUA target levels at Week 12, Week 24 and Week 36 after having reached the sUA target levels at Week 2;
    • Tender and swollen joint count;
    • Pulse Wave Analysis (including modifications of PWV, arterial stiffness, central blood pressure and augmentation index) after 12, 24 and 36 weeks of treatment;
    • Changes in endothelial activation/adhesion markers (sVCAM, sICAM, vWF, e-selectine) after 12, 24 and 36 weeks of treatment (These parameters will be evaluated in a subset of patients enrolled in selected centres only)

    The following laboratory parameters will be performed in central lab:
    • BNP, NTproBNP
    • Markers of inflammation: hsCRP, TNF-α, plasma fibrinogen
    • Oxidative stress parameters: MDA, MPO, Ox-LDL, PON1, PON2
    • Markers of endothelial activation/adhesion: sVCAM, sICAM, vWF, e-selectine
    • sUA, eGF, Serum creatinine and urine albumin to creatinine ratio
    • Lipid profile
    E.5.2.1Timepoint(s) of evaluation of this end point
    after 12, 24 and 36 weeks of treatment
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 Yes
    E.8.1.7.1Other trial design description
    evaluator blind
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA29
    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
    Croatia
    Germany
    Italy
    Netherlands
    Poland
    Romania
    Serbia
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    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: 122
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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.4.2 For a multinational trial
    F.4.2.1In the EEA 147
    F.4.2.2In the whole clinical trial 182
    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)
    Standard of care
    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 Decision2015-05-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-05-10
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