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    Summary
    EudraCT Number:2013-003587-31
    Sponsor's Protocol Code Number:MK8835-001
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-05-26
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2013-003587-31
    A.3Full title of the trial
    A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Ertugliflozin (MK-8835/PF-04971729) in Subjects with Type 2 Diabetes Mellitus with Stage 3 Chronic Kidney Disease Who Have Inadequate Glycemic Control on Background Antihyperglycemic Therapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to test if the drug ertugliflozin is safe and effective when compared to placebo in patients with Type 2 Diabetes and stage 3 chronic kidney disease whose sugar levels are not well controlled by their current treatment.
    A.3.2Name or abbreviated title of the trial where available
    MK-8835/PF-04971729 vs. Placebo in T2DM Subjects with Stage 3 Chronic Kidney Disease
    A.4.1Sponsor's protocol code numberMK8835-001
    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 SponsorMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.1.3.4CountryUnited States
    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 supportMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.5.2Functional name of contact pointElizabeth Ommen
    B.5.3 Address:
    B.5.3.1Street AddressOne Merck Drive
    B.5.3.2Town/ cityP.O. Box 100, Whitehouse Station
    B.5.3.3Post codeNJ 08889-0100
    B.5.3.4CountryUnited States
    B.5.4Telephone number0017325945809
    B.5.6E-mailelizabeth.ommen@merck.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 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 nameertugliflozin 10mg
    D.3.2Product code MK-8835
    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 INNertugliflozin
    D.3.9.2Current sponsor codeMK-8835
    D.3.9.3Other descriptive nameertugliflozin•L-PGA
    D.3.9.4EV Substance CodeSUB31037
    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.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 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 nameertugliflozin 5mg
    D.3.2Product code MK-8835
    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 INNertugliflozin
    D.3.9.2Current sponsor codeMK-8835
    D.3.9.3Other descriptive nameertugliflozin•L-PGA
    D.3.9.4EV Substance CodeSUB31037
    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.8 Information on Placebo
    D.8 Placebo: 1
    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: 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Type 2 Diabetes Mellitus with Stage 3 Chronic Kidney Disease Who Have Inadequate Glycemic Control on Background Antihyperglycemic Therapy
    E.1.1.1Medical condition in easily understood language
    Type 2 Diabetes with Stage 3 Chronic Kidney Disease Whose Sugar Levels are NOT Well Controlled by Their Current Treatment
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10063624
    E.1.2Term Type II diabetes mellitus inadequate control
    E.1.2System Organ Class 100000004861
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10045250
    E.1.2Term Type II diabetes mellitus with renal manifestations
    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
    In subjects with T2DM and inadequate glycemic control on standard diabetes therapy with a Visit 3/Week -2 eGFR of ≥30 to <60 mL/min/1.73m2, after 26 weeks:
    1. To assess the A1C-lowering efficacy of the addition of ertugliflozin 15 mg q.d. compared to the addition of placebo.
    2. To assess the A1C-lowering efficacy of the addition of ertugliflozin 5 mg q.d. compared to the addition of placebo.
    3. To assess the safety and tolerability of ertugliflozin.
    E.2.2Secondary objectives of the trial
    1. To assess the A1C-lowering efficacy of the addition of ertugliflozin 15 mg q.d. compared to the addition of placebo.
    2. To assess the A1C-lowering efficacy of the addition of ertugliflozin 5 mg q.d. compared to the addition of placebo.
    3. To assess the effect of the addition of ertugliflozin 15 mg q.d. compared with the addition of placebo on the change from baseline in body weight.
    4. To assess the effect of the addition of ertugliflozin 15 mg q.d. compared with the addition of placebo on the change from baseline in systolic blood pressure.
    5. To assess the effect of the addition of ertugliflozin 5 mg q.d. compared with the addition of placebo on the change from baseline in body weight.
    6. To assess the effect of the addition of ertugliflozin 5 mg q.d. compared with the addition of placebo on the change from baseline in systolic blood pressure.

    Please see Protocol Section 3.2 for the full list of secondary objectives
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    At Visit 1/Screening

    1. Have T2DM in accordance with ADA guidelines [1] and be ≥25 years of age on the day of signing the informed consent form.

    2. Meet one of the following criteria:
    a) Subject is not on metformin: Subject is on stable diabetes therapy (diet/exercise therapy alone or AHA monotherapy or combination therapy) for ≥6 weeks prior to Visit 1/Screening with a Visit 1/Screening A1C of 7.0%-10.5% (53-91 mmol/mol), inclusive.
    Note: Allowable AHAs include injectable and oral agents except metformin, rosiglitazone, and other SGLT2 inhibitors (see Section 5.5 for excluded medications).
    or
    b) Subjects is on metformin: Subject is on metformin (with or without diet/exercise therapy or other AHA therapy) with a Visit 1/Screening A1C of 6.5%-10.0% (48-86 mmol/mol), inclusive, and is willing to undergo a 10-week metformin wash-off period.
    Note: Subjects who wash-off metformin can have their AHAs adjusted (i.e., dose
    change of current AHA(s) or initiation of new AHA) with the exception of pioglitazone. Subjects on pioglitazone should remain on the same dose and pioglitazone must not be initiated in subjects who are not already on pioglitazone.

    3. Have an eGFR of ≥30 to <60 mL/min/1.73m2 (calculated using the MDRD formula).
    Note: Subjects who do not meet the eGFR entry criterion may have one repeat determination performed if the investigator considers the Visit 1/Screening result to be inconsistent with prior determinations.

    4. Have a Body Mass Index (BMI) >18.0 kg/m2.

    5. Have personally signed and dated informed consent document indicating that he/she has been informed of all pertinent aspects of the trial. The subject may also provide consent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.

    6. Be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

    7. Meet one of the following criteria:
    a. Subject is a male
    b. Subject is a female not of reproductive potential defined as one who:
    (1) is postmenopausal (defined as at least 12 months with no menses in women ≥45 years of age), or
    (2) has had a hysterectomy and/or bilateral oophorectomy, or had bilateral tubal ligation or occlusion at least 6 weeks prior to Visit 1.
    c. Subject is a female of reproductive potential and:
    (1) agrees to remain abstinent from heterosexual activity (if this form of birth control is accepted by local regulatory agencies and ethics review committees as the sole method of birth control for subjects participating in clinical trials), or
    (2) agrees to use (or have her partner use) acceptable contraception to prevent
    pregnancy while receiving investigational product and for 14 days after the last dose of investigational product. Two methods of contraception will be used to avoid pregnancy. Acceptable combinations of methods include:
    • Use of one of the following double-barrier methods: diaphragm with spermicide and a condom; cervical cap and a condom; or a contraceptive sponge and condom.
    • Use of hormonal contraception (any registered and marketed contraceptive
    agent that contains an estrogen and/or a progestational agent [including oral, subcutaneous, intrauterine and intramuscular agents, and cutaneous patch]) with one of the following: diaphragm with spermicide; cervical cap; contraceptive sponge; condom; vasectomy; or IUD.
    • Use of an IUD with one of the following: condom; diaphragm with spermicide; contraceptive sponge; vasectomy; or hormonal contraception (see above).
    • Vasectomy with one of the following: diaphragm with spermicide; cervical
    cap; contraceptive sponge; condom; IUD; or hormonal contraception (see above).

    At Visit 3/Week -2

    8. Have an A1C of 7.0%-10.5% (53-91 mmol/mol), inclusive, in subjects who have undergone metformin wash-off.

    9. Have an eGFR of ≥30 to <60 mL/min/1.73m2 (calculated using the MDRD formula) with <10 mL/min/1.73m2 change in eGFR from Visit 1 to Visit 3.
    Note: If the Visit 1/Screening eGFR is repeated to determine eligibility, the repeat eGFR value should be used to determine the change in eGFR, and the measurements must be at least 4 weeks apart.

    At Visit 4/ Randomization (Day 1)

    10. Be ≥80% compliant with the single-blind placebo run-in medication (as determined by site-performed pill count).
    E.4Principal exclusion criteria
    At Visit 1/Screening

    Diabetes Diagnosis, Renal-related Medical History, and Prior Therapy Criteria
    1. Has a history of type 1 diabetes mellitus or a history of ketoacidosis.
    2. Has a history of other secondary causes of diabetes (e.g., genetic syndromes, secondary pancreatic diabetes, diabetes due to endocrinopathies, drug- or chemical-induced, and post-organ transplant).
    3. Has a history of nephrotic range proteinuria (>3000 mg/day) with hypoalbuminemia and edema.
    4. Has a history of rapidly progressive glomerulonephritis, lupus nephritis, renal or systemic vasculitis, renal artery stenosis with renovascular hypertension, or ischemic nephropathy.
    5. Has a history of familial renal glucosuria.
    6. Has a history of renal dialysis or renal transplant or renal disease requiring treatment with any immunosuppressive agent.
    7. Has a known hypersensitivity or intolerance to any SGLT2 inhibitor.
    8. Meets any of the following criteria:
     Subject is on a weight-loss program and is not weight-stable.
     Subject is on a weight-loss medication (e.g., orlistat, phentermine/topiramate, lorcaserin) and is not weight-stable.
     Subject is on other medications associated with weight changes (e.g., antipsychotic agents) and is not weight-stable.
     Subject has undergone bariatric surgery >12 months prior to Visit 1/Screening and is not weight-stable.
     Subject has undergone bariatric surgery within 12 months of Visit 1/Screening.
    Note: Weight-stable is defined as <5% change in body weight in the last 6 months.

    9. Has been treated with any of the following agents (not permitted within 12 weeks of Visit 1/Screening or during the pre-randomization period):
     Rosiglitazone
     Other SGLT2 inhibitors

    10. Has active, obstructive uropathy or indwelling urinary catheter.

    Concomitant Disease of Organs and Systems
    11. Has a history of myocardial infarction, unstable angina, arterial revascularization, stroke, transient ischemic attack, or NYHA functional class III-IV heart failure within 3 months of Visit 1/Screening.
    12. Has a history of malignancy ≤5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
    Note (1) A subject with a history of malignancy >5 years prior to signing informed consent should have no evidence of residual or recurrent disease.
    Note (2) A subject with any history of melanoma, leukemia, lymphoma, or renal cell carcinoma is excluded.
    13. Has human immunodeficiency virus (HIV) as assessed by medical history.
    14. Has
     Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells, or
     Any other clinically significant hematological disorder (such as aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia)
    15. Has a medical history of active liver disease (other than non-alcoholic hepatic steatosis), including chronic active hepatitis B or C (assessed by medical history), primary biliary cirrhosis, or active symptomatic gallbladder disease.
    16. Has any clinically significant malabsorption condition.
    17. Is currently being treated for hyperthyroidism.
    18. Has not been on a stable dose of thyroid replacement therapy for at least 6 weeks prior to Visit 1. Subjects who meet this criterion may be re-screened after being on a stable dose of thyroid replacement therapy for at least 6 weeks.

    19. Has an exclusionary laboratory value as listed in Table 2 (see protocol page 27)

    Other Criteria

    20. Has been previously randomized in a study with ertugliflozin.
    21. Has participated in other studies involving investigational drug(s) (Phase I-IV) within 30 days prior to Visit 1/Screening and/or during trial participation.
    22. Has undergone a surgical procedure within 6 weeks prior to signing informed consent or has planned major surgery during the trial.
    Note: A subject who has undergone minor surgery within the 6 weeks prior to
    Visit 1/Screening and is fully recovered or a subject who has planned minor surgery may participate. Minor surgery is defined as a surgical procedure involving local anesthesia.
    23. Has a positive urine pregnancy test.
    24. Is pregnant or breast-feeding, or is planning to conceive during the trial, including 14 days following the last dose of blinded investigational product.
    25. Is planning to undergo hormonal therapy in preparation to donate eggs during the trial, including 14 days following the last dose of blinded investigational product.

    See protocol section 5.1.3 for the full list of exclusion critieria.
    E.5 End points
    E.5.1Primary end point(s)
    1. Body weight
    2. Vital Signs (pulse rate and blood pressure)
    3. Post Ural blood pressure and pulse rate
    4. 12-lead ECG
    5. Fasting fingerstick glucose (in clinic)
    6. Review of SMBG Measurements and HAL
    7. Adverse event monitoring
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Each visit
    2. Each visit
    3. Visits 3, 4, 5, 8, rescue
    4. Visits 3, 4, 8, 11, rescue, discontinuation
    5. Visit 4
    6. Visits 3-11, rescue, discontinuation
    7. Throughout the study
    E.5.2Secondary end point(s)
    Laboratory Procedures/ Assessments

    8. FPG
    9. A1C
    10. Lipid Panel
    11. Chemistry Panel
    12. Hematology
    13. Urine Collection/Urinalysis and Urine Albumin: Creatinine Ratio
    14. Urine Pregnancy Test (women of childbearing potential only)
    15. Bone Biomarkers, PTH and Vitamin D levels
    16. PK Sample for ertugliflozin: pre-dose
    17. PK Sample for ertugliflozin: 1h post
    dose
    18. Plasma and serum for Future Biomedical Research
    19. Blood (DNA) for Future Biomedical
    Research
    E.5.2.1Timepoint(s) of evaluation of this end point
    8. Visits 1, 4-11, rescue, discontinuation
    9. Visits 1, 3-11, rescue, discontinuation
    10. Visits 4, 8, 11, rescue, discontinuation
    11. Visits 1, 3-11, rescue, discontinuation, follow-up
    12. Visits 1, 3, 4, 5, 7-11, rescue, discontinuation, follow-up
    13. Visits 2, 4, 8, 11, rescue, discontinuation
    14. Visits 1, 3-11, rescue, discontinuation
    15. Visits 4, 8, 11, discontinuation
    16. Visits 5-7
    17. Visit 6
    18. Visits 4, 8, 11, discontinuation
    19. Visit 4
    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 Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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 Yes
    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 concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA90
    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
    Argentina
    Bulgaria
    Canada
    Colombia
    Germany
    Hungary
    Israel
    Mexico
    Peru
    Philippines
    Poland
    Romania
    Russian Federation
    South Africa
    Spain
    United Kingdom
    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
    LVLS
    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 months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    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: 238
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 230
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 129
    F.4.2.2In the whole clinical trial 468
    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 Decision2014-08-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-09-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-09-28
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