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The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
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    The EU Clinical Trials Register currently displays   42732   clinical trials with a EudraCT protocol, of which   7035   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).

    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    EudraCT Number:2015-000700-26
    Sponsor's Protocol Code Number:178-CL-203
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-07-01
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2015-000700-26
    A.3Full title of the trial
    A multicentre, open-label, single dose, phase 1 study to evaluate the pharmacokinetics, safety and tolerability of mirabegron oral suspension in pediatric subjects from 3 to less than 12 years of age with neurogenic detrusor overactivity (NDO) or overactive bladder (OAB)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This is a short study, performed in different countries, to investigate how well one dose of mirabegron mirabegron suspension is taken, how long it stays in the body and how well it is tolerated in children aged 5 to less than 12 years with symptoms of overactive bladder (possibly caused by nerve dysfunction)
    A.4.1Sponsor's protocol code number178-CL-203
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/269/2015
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAstellas Pharma Europe B.V.
    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 B.V.
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstellas Pharma Europe B.V.
    B.5.2Functional name of contact pointGlobal Development Operations
    B.5.3 Address:
    B.5.3.1Street AddressSylviusweg 62
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 BE
    B.5.4Telephone number0031(0)715455878
    B.5.5Fax number0031(0)715455224
    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 No
    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 Granules for oral suspension
    D.3.4.1Specific paediatric formulation Yes
    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/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    -neurogenic detrusor overactivity (NDO)
    -overactive bladder (OAB)
    E.1.1.1Medical condition in easily understood language
    -not being able to control urination (incontinence)
    -strong urge to urinate
    E.1.1.2Therapeutic area Body processes [G] - Biological Phenomena [G16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10012547
    E.1.2Term Detrusor hyperreflexia
    E.1.2System Organ Class 100000004857
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    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
    The primary objective of the trial is to evaluate the pharmacokinetics (PK) of mirabegron oral suspension after single dose administration in children with neurogenic detrusor overactivity (NDO) or overactive bladder (OAB).
    E.2.2Secondary objectives of the trial
    The secondary objective of the trial is:
    - to evaluate the safety and tolerability of mirabegron oral suspension after single dose administration in children with NDO or OAB.
    - to evaluate the acceptability and palatability of mirabegron oral suspension after single dose administration in children with NDO or OAB.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved written Informed Consent/Assent and privacy language as per national regulations (e.g., HIPAA Authorization for U.S. sites) must be obtained from the subject and from the subject’s parent(s) or legal guardian(s) prior to any study-related procedures (including discontinuation of prohibited medication, if applicable); assent by the subject is given as required by local law.
    2. Subject is male or female from 3 to less than 12 years of age.
    3. Subject has a documented diagnosis according to the International Children’s Continence Society ICCS criteria of: NDO, or Idiopathic OAB
    4. Subject’s weight/height:
    • Subject must have a body weight of ≥ 15.0 kg
    • For NDO: subject is not suffering from malnutrition or is not grossly overweight, in the opinion of the Investigator
    • For OAB: subject’s weight and height are within the normal percentiles (3rd to 97th percentile) according to Centers for Disease Control and Prevention (CDC) growth charts.
    5. Subject is able to swallow the study medication in accordance with the protocol.
    6. Subject and subject’s parent(s)/legal guardian agree that the subject will not participate in another interventional study while on treatment.
    7. Subject and subject’s parent(s)/legal guardian are willing and able to comply with the studyrequirements and with the concomitant medication restrictions.
    8. Female subject must:
    • Be of non-childbearing potential: Clearly pre-menarchal or in the judgment of the Investigator is pre-menarchal
    Or the following inclusion criteria are to be followed, if applicable (rare cases).
    • Female subject that reached puberty must:
    - Agree not to try to become pregnant during the study and for 28 days after the final study drug administration,
    - And have a negative urine pregnancy test predose Day 1,
    - And, if heterosexually active agree to consistently use 2 forms of highly effective form of birth control* starting at screening and throughout the study period and for 28 days after the final study drug administration
    E.4Principal exclusion criteria
    1. Subject has a known history of QTc prolongation or risk of QT prolongation (e.g. hypokalemia, family history of Long QT Syndrome) and/or QTcB of > 460 ms.
    2. Subject has a (mean) resting pulse rate > 99th percentile [Fleming et al, 2011].
    3. Subject has any clinically significant ECG (electrocardiogram) abnormality.
    4. Subject has an established hypertension and a systolic or diastolic blood pressure greater than the 99th percentile of the normal range determined by sex, age and height, plus 5 mmHg [NIH 2005].
    5. Subject has any clinically significant or unstable medical condition or disorder which, in the opinion of the Investigator, precludes the subject from participating in the study.
    6. Subject has current, untreated constipation (or fecal impaction for NDO subjects). If the constipation is being consistently treated for the last month, the subject can be included.
    7. Subject has been administered intradetrusor botulinum toxin injections; except if given > 4months prior to screening and symptoms reappeared comparable to those before botulinum toxin injections.
    8. Subject has aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than or equal to 2 times the ULN or total bilirubin greater than or equal to 1.5 times the ULN.
    9. Subject has severe renal impairment (estimated glomerular filtration rate < 30 mL/min (Larsson)).
    10. Subject has any other clinically significant out of range results of urinalysis, biochemistry or hematology.
    11. Subject has a history or current diagnosis of any malignancy.
    12. Subject has known or suspected hypersensitivity to mirabegron, other ß3-agonists, any of the excipients used in the mirabegron oral suspension formulation or previous severe hypersensitivity to any drug.
    13. Subject meets any of the contra indications or precautions for use of mirabegron listed in the Investigator’s Brochure (IB).
    14. Subject has used mirabegron within 12 days of the planned Reference Day (Day -4 to Day -1).
    15. Subject requires ongoing treatment with any of the following prohibited medications:
    • Any anticholinergic/antimuscarinic drugs within 5 half-lives prior to planned Reference Day (Day -4 to Day -1).
    • Any drugs that are sensitive CYP2D6 substrates with a narrow therapeutic index (such as thioridazine, flecainide, propafenone, imipramine, desipramine) and sensitive P-gp substrates (such as digoxin, dabigatran) within 5 half-lives prior to the planned Reference Day (Day -4 to Day -1).
    • Any moderate or strong cytochrome CYP3A4/5 or P-gp inhibitors or inducers including natural and herbal remedies (such as itraconazole, rifampicin, phenytoin, carbamazepine, St.John’s Wort, grapefruit, Seville orange) within 4 weeks (inducers only) or 5 half-lives (inhibitors only) prior to the planned Reference Day (Day -4 to Day -1).
    16. Subject has participated in another clinical trial and/or has taken an investigational drug within 30 days (or 5 half-lives of the investigational drug, whichever is longer) prior to the planned Reference Day (Day -4 to Day -1).
    17. Subject’s parent(s)/legal guardian is an employee of the Astellas Group, any Contract Research Organization (CRO) involved, or the Investigator site executing the study.
    E.5 End points
    E.5.1Primary end point(s)
    Pharmacokinetics of mirabegron:
    Cmax, AUCinf, tmax, and t1/2 . Additional PK parameters may be calculated.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 1, Day 2, Day 3-6, Day 4-7
    E.5.2Secondary end point(s)
    Nature, frequency and severity of adverse events, clinical laboratory evaluations (hematology, biochemistry, urinalysis), vital signs (including 24-hr Holter HR (heart rate)), ECG (including interval measurements), post-void residual volume (PVR)

    Acceptability and Palatability:
    Taste and acceptance of the suspension (5-point scale)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety: Safety labs at screening and day 2 are required to be drawn. For any AE that may impact safety labs (e.g. a urinary tract infection) and occurs between Screening and Day 1, and/or Day 2 and EOS, an additional safety lab needs to be taken at Day 1 and/or the EOS visit respectively

    Acceptability and Palatability: Day 1 (shortly after dosing)
    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 Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    tolerability, acceptability and palatability
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E. trial type description
    paediatric phase I in patients
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 EEA3
    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
    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 days0
    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 Yes
    F.1.1Number of subjects for this age range: 9
    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) Yes
    F. of subjects for this age range: 9
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 9
    F.4.2.2In the whole clinical trial 9
    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)
    There are no plans for treatment or care after the subject has ended the participation in the trial
    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 Decision2015-08-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-09-30
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