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    Summary
    EudraCT Number:2012-005401-41
    Sponsor's Protocol Code Number:905-EC-012
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-07-08
    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 ConcernedGreece - EOF
    A.2EudraCT number2012-005401-41
    A.3Full title of the trial
    A Randomized, Double-Blind, Multi-Centre Study to Evaluate the Efficacy and Safety of Adding Mirabegron to Solifenacin in Incontinent OAB Subjects who have Received Solifenacin for 4 Weeks and Warrant Additional Relief for their OAB Symptoms.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial comparing combination treatment (solifenacin plus mirabegron) with one treatment alone (solifenacin).
    A.3.2Name or abbreviated title of the trial where available
    BESIDE
    A.4.1Sponsor's protocol code number905-EC-012
    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 SponsorAstellas Pharma Europe Ltd
    B.1.3.4CountryUnited Kingdom
    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 supportAstellas Pharma Europe Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlobal Development Operations
    B.5.2Functional name of contact pointService Desk
    B.5.3 Address:
    B.5.3.1Street AddressSylviusweg 62
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 BE
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310715455878
    B.5.5Fax number00310715455224
    B.5.6E-mailcontact@nl.astellas.com
    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 Betmiga
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma Europe BV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 namemirabegron
    D.3.2Product code YM178
    D.3.4Pharmaceutical form Prolonged-release 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 INNmirabegron
    D.3.9.1CAS number 223673-61-8
    D.3.9.2Current sponsor codeYM178
    D.3.9.3Other descriptive nameMIRABEGRON
    D.3.9.4EV Substance CodeSUB32690
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 Betmiga
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma Europe BV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 namemirabegron
    D.3.2Product code YM178
    D.3.4Pharmaceutical form Prolonged-release 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 INNmirabegron
    D.3.9.1CAS number 223673-61-8
    D.3.9.2Current sponsor codeYM178
    D.3.9.3Other descriptive nameMIRABEGRON
    D.3.9.4EV Substance CodeSUB32690
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Vesicare
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma Europe BV
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 namesolifenacin succinate
    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 INNsolifenacin succinate
    D.3.9.1CAS number 242478-38-2
    D.3.9.2Current sponsor codeYM905
    D.3.9.3Other descriptive nameSOLIFENACIN SUCCINATE
    D.3.9.4EV Substance CodeSUB21028
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 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 Vesicare
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma Europe BV
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 namesolifenacin succinate
    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 INNsolifenacin succinate
    D.3.9.1CAS number 242478-38-2
    D.3.9.2Current sponsor codeYM905
    D.3.9.3Other descriptive nameSOLIFENACIN SUCCINATE
    D.3.9.4EV Substance CodeSUB21028
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 placeboProlonged-release tablet
    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 placeboFilm-coated tablet
    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 placeboProlonged-release tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 4
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    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
    Overactive Bladder
    E.1.1.1Medical condition in easily understood language
    Overactive bladder
    E.1.1.2Therapeutic area Body processes [G] - Physical Phenomena [G01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10059617
    E.1.2Term Overactive bladder
    E.1.2System Organ Class 100000004857
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of solifenacin 5 mg plus mirabegron 50 mg versus solifenacin 5 mg monotherapy
    E.2.2Secondary objectives of the trial
    - To evaluate the safety and tolerability of combination therapy versus solifenacin 5mg and solifenacin 10mg monotherapy
    - To evaluate the efficacy of combination therapy versus solifenacin 10mg monotherapy
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    At screening (visit 1):
    1. Subject is male or female and at least 18 years of age;
    2. Subject has symptoms of OAB (urinary frequency and urgency
    with urgency incontinence) for > 3 months prior to the screening visit;
    3. Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved written Informed Consent (IC) and
    privacy language as per national regulations has been obtained
    from the subject or legally authorized representative prior to any study-related procedures (including discontinuation of prohibited medication, if applicable);
    4. Female subject must be either:
    • Of non child bearing potential:
    • post-menopausal (defined as at least 1 year without any
    menses in the absence of other plausible aetiology) prior to
    Screening or
    • documented surgically sterile or status post hysterectomy
    (at least 1 month prior to Screening)
    • Or, if of childbearing potential,
    •must have a negative serum pregnancy test at Screening and
    must use a highly effective method of birth control, which
    include established use of oral, injected or implanted hormonal
    methods of contraception, placement of an intrauterine device
    (IUD) or intrauterine system (IUS), or barrier methods of
    contraception: condom or occlusive cap (diaphragm or
    cervical/vault caps) with spermicidal
    foam/gel/film/cream/suppository. Birth control must be
    practiced from the Screening visit, throughout the study period
    and for 28 days after final study drug administration;
    5. Female subject must not be breastfeeding at Screening or
    during the study period and for 28 days after final study drug
    administration;
    6. Female subject must not donate ova starting at Screening and
    throughout the study period and for 28 days after final study
    drug administration;
    7. Male subjects and their female spouse/partners who are of
    childbearing potential must be using highly effective contraception starting at Screening and continue throughout the study period and for 90 days after final study drug administration;
    8. Male subject must not donate sperm starting at Screening and
    throughout the study period and for at least 90 days after final
    study drug administration;
    9. Subject is willing and able to complete the micturition diary
    and questionnaires correctly, including collection and
    measurement of urine output for 3 days prior to each visit;
    10. Subject has symptoms of “wet” OAB (urinary frequency and
    urgency with incontinence or mixed incontinence with
    predominant urgency incontinence), and reports an average of
    at least 2 incontinence episodes per 24 hour period.

    At run-in (visit 2):
    11. Subject experiences on average at least 1 episode of urgency
    (grade 3 or 4) with or without incontinence per 24-hour period
    during the 3-day micturition diary period.
    12. Subject experiences on average at least 2 incontinence
    episodes per 24-hour period during the 3-day micturition diary
    period.
    13. Subject experiences on average at least 8 micturitions
    (excluding incontinence episodes) per 24-hour period during
    the 3-day micturition diary period.

    At randomization (visit 3):
    14. Subject experiences at least 1 incontinence episode during the
    3-day micturition diary period and wishes to increase their
    treatment for OAB symptoms.
    E.4Principal exclusion criteria
    Subjects will be excluded from participation if any of the
    following apply:

    At screening (visit 1):
    1. Subject in the opinion of the investigator has clinically
    significant Bladder Outlet Obstruction (BOO).
    2. Subject has significant PVR volume (PVR > 150 ml).
    3. Subject has significant stress incontinence or mixed
    stress/urgency incontinence where stress is the predominant
    factor as determined by the investigator
    4. Subject has an indwelling catheter or practices intermittent
    self-catheterization.
    5. Subject has evidence of a Urinary Tract Infection (UTI). If a
    urine dipstick shows positive for nitrite, this must be followed
    up with a urine sediment and then culture (if the sediment is
    positive). The subject should be treated with an appropriate
    course of antibiotics. The subject can be enrolled into the study
    after successful treatment of the UTI, which is confirmed by a
    dipstick test negative for nitrites. If more than 28 days has
    passed since the initial screening visit, the subject must repeat
    the screening assessments.
    6. Subject has chronic inflammation such as interstitial cystitis,
    bladder stones, previous pelvic radiation therapy, or previous
    or current malignant disease of the pelvic organs (i.e., within
    the confines of the pelvis including the bladder and rectum in
    both sexes, the prostate in males and the uterus, ovaries, and
    fallopian tubes in females; organs of the lower gastrointestinal
    tract are not necessarily considered pelvic organs as the distal
    ascending colon, the full transverse colon and proximal portion
    of the descending colon are in the abdomen).
    7. Subject has received intravesical treatment in the past 12
    months with e.g., botulinum toxin, resiniferatoxin, capsaicin.
    8. Subject has uncontrolled narrow angle glaucoma, urinary or
    gastric retention, severe ulcerative colitis, toxic megacolon,
    myasthenia gravis or any other medical condition which in the
    opinion of the investigator makes the use of anticholinergics
    contraindicated.
    9. Subject receives non-drug treatment including sacral nerve
    stimulation therapy (a bladder training program or pelvic floor
    exercises which started more than 30 days prior to entry into
    the study can be continued).
    10. Subject has moderate to severe hepatic impairment defined as
    Child-Pugh Class B or C.
    11. Subject has severe renal impairment or End Stage Renal
    disease defined as eGFR < 30 ml/min/1.73 m2.
    12. Subject has serum creatinine > 150 μmol/L, AST and/or ALT
    > 2x upper limit of normal (ULN), γ-GT > 3x ULN, or total
    bilirubin 2x ULN, as assessed in screening samples.
    13. Subject has severe uncontrolled hypertension, which is defined
    as a sitting average systolic blood pressure ≥ 180 mmHg
    and/or average diastolic blood pressure ≥ 110 mmHg.
    14. Subject has a QTcF interval > 450 ms for males or > 470 ms
    for females or is at risk of QT prolongation (e.g., family
    history of long QT syndrome, hypokalaemia).
    15. Subject has a clinically significant abnormal ECG.
    16. Subject has a known or suspected hypersensitivity to
    solifenacin, mirabegron or any of the inactive ingredients. This
    includes subjects with rare hereditary problems of galactose
    intolerance, the Lapp lactase deficiency or glucose-galactose
    malabsorbtion.
    17. Subject has any other clinically significant condition, which in
    the opinion of the investigator makes the subject unsuitable for
    the study.
    18. Subject has been treated with an experimental device within
    30 days or received an experimental agent within 30 days or
    five half-lives whichever is longer, prior to study drug
    administration. If local regulations stipulate a longer period, such local regulations should take precedence.
    19. Subject has a concurrent malignancy or history of cancer
    (except noninvasive skin cancer) within the last 5 years prior
    to screening. Subjects with a history of cancer are considered
    eligible if the subject has undergone therapy and the subject
    has been considered disease free for at least 5 years.
    20. Subject is using prohibited medications which cannot be
    stopped safely at the Screening Visit (these include potent
    CYP3A4 inhibitors (e.g. ketoconazole, ritonavir, nelfinavir,
    itraconazole).
    21. Subject is an employee of the Astellas Group, third parties
    associated with the study, or the clinical study site team.

    At randomization (visit 3):
    22. Subject has achieved 100% continence from Visit 2 to Visit 3
    (no incontinence episodes are recorded in the 3 day diary
    administered for 3 days prior to Visit 3).
    23. Subject does not desire an increase in study medication.
    24. Subject has an average total daily urine volume > 3000ml as
    recorded in the micturition diary.
    25. Subject has severe uncontrolled hypertension, which is defined
    as a sitting average systolic blood pressure ≥ 180 mmHg
    and/or average diastolic blood pressure ≥ 110 mmHg.
    26. Subject has a clinically significant abnormal ECG
    E.5 End points
    E.5.1Primary end point(s)
    Change from Baseline in mean number of incontinence episodes.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline visit (Visit 3/Randomization) to End of Treatment (Visit 6).
    E.5.2Secondary end point(s)
    1. Change from Baseline in mean number of micturitions per 24 hours.
    2. Number of incontinence episodes reported over 3-day diary.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline Visit (Visit 3/Randomization) to end of Treatment (Visit 6).
    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) Yes
    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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA165
    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
    Algeria
    Armenia
    Australia
    Canada
    Egypt
    Georgia
    Israel
    Jordan
    Kazakhstan
    Korea, Republic of
    Lebanon
    New Zealand
    Russian Federation
    Taiwan
    Turkey
    Ukraine
    United States
    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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days0
    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: 1410
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 760
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 530
    F.4.2.2In the whole clinical trial 2170
    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
    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 Decision2013-09-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-11-21
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