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    Summary
    EudraCT Number:2017-002817-78
    Sponsor's Protocol Code Number:D5670C00007-Amendment1
    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:2018-02-21
    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 number2017-002817-78
    A.3Full title of the trial
    An Exploratory Phase 2a Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of MEDI0382 versus Placebo in Overweight/Obese Subjects with Type 2 Diabetes Mellitus Treated with Dapagliflozin and Metformin
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to look at how safe, well tolerated, and what effect on the body and on blood glucose, different doses of study drug MEDI0382 has in patients who are obese and overweight and have high blood sugar (type 2 diabetes) currently treated with dapagliflozin and metformin.
    A.4.1Sponsor's protocol code numberD5670C00007-Amendment1
    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 SponsorMedImmune Limited, a wholly owned subsidiary of AstraZeneca
    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 supportMedImmune Limited, a wholly owned subsidiary of AstraZeneca
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedImmune LTD, a wholly owned subsidiary of AstraZeneca
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street AddressMilstein Building, Granta Park
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeCB21 6GH
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailinformation.center@astrazeneca.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.3.2Product code MEDI0382
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN-
    D.3.9.1CAS number 1686108-82-6
    D.3.9.2Current sponsor codeMEDI0382
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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.3.2Product code MEDI0382
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN-
    D.3.9.1CAS number 1686108-82-6
    D.3.9.2Current sponsor codeMEDI0382
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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 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.3.2Product code MEDI0382
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN-
    D.3.9.1CAS number 1686108-82-6
    D.3.9.2Current sponsor codeMEDI0382
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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 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.3.2Product code Dapagliflozin
    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 INNDapagliflozin
    D.3.9.2Current sponsor codeDapagliflozin
    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 placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous 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
    E.1.1.1Medical condition in easily understood language
    High sugar levels in the blood
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10067585
    E.1.2Term Type 2 diabetes mellitus
    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
    To compare the change in glucose AUC as measured by a standardized MMTT in subjects treated with dapagliflozin and metformin receiving MEDI0382 or placebo for 28 days
    E.2.2Secondary objectives of the trial
    • To compare the safety and tolerability profile of MEDI0382 (titrated up to a dose level of 300 µg SC) compared to placebo after 28 days of treatment in subjects treated with dapagliflozin and metformin

    • To evaluate the PK profile of MEDI0382 and dapagliflozin (in subjects treated with dapagliflozin, metformin, and MEDI0382) and dapagliflozin (in subjects treated with dapagliflozin, metformin, and placebo)

    • To evaluate the immunogenicity profile of MEDI0382 (titrated up to a dose level of 300 µg) in subjects treated with dapagliflozin and metformin receiving MEDI0382 for 28 days

    • To evaluate 24-hour glucose control as measured by continuous glucose monitoring (CGM) in subjects treated with dapagliflozin and metformin receiving MEDI0382 or placebo for 28 days
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female subjects aged ≥ 18 years at screening.

    2. Provision of signed and dated informed consent form (ICF) prior to any study specific procedures.

    3. BMI between 25 kg/m2 and 40 kg/m2 (inclusive) at screening.

    4. HbA1c range between 7.0% and 10.0% (inclusive) at the time of screening.

    5. Diagnosed with T2DM and treated with of metformin monotherapy (MTD ≥ 1 g) at least 8 weeks prior to screening or treated with stable, oral doses of dapagliflozin 10 mg and metformin (MTD ≥ 1 g) for at least 3 months prior screening.

    6. Subjects prescribed oral dual therapy with sulphonylurea, glitinide, or dipeptidyl peptidase-4 inhibitor (in addition to metformin) may be eligible to enter the study following a washout period of these medications totaling at least 28 days before initial screening evaluations have been completed.

    7. Subjects treated with stable doses of metformin≥MTD ≥ 1 g with canagliflozin (maximum dose of 300 mg/day) or metformin (MTD ≥ 1 g) with empagliflozin (maximum dose of 25 mg/day) for at least 3 months prior to screening may be eligible to enter the study after switching to dapagliflozin 10 mg at least 2 weeks prior to Day -2.

    8. Female subjects of childbearing potential must have a negative pregnancy test at screening and randomization and must not be lactating.

    9. Females of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective method of contraception from screening and must agree to continue using such precautions through to the end of the study (see Section 10.2 for accepted methods of contraception). It is strongly recommended for the male partner of a female subject to also use male condom plus spermicide throughout this period. Cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception.
    E.4Principal exclusion criteria
    1. History of, or any existing condition that in the opinion of the investigator would interfere with evaluation of the investigational product, put the subject at risk, influence the subject’s ability to participate, or affect the interpretation of the results of the study and/or any subject unable or unwilling to follow study procedures

    2. Any subject who has received another investigational product not included in the protocol as part of a clinical trial or a GLP-1 analogue or other investigational SGLT2-containing preparation (excluding dapagliflozin, canagliflozin, and empagliflozin) within the last 30 days or 5 half-lives of the drug (whichever is longest) at the time of screening

    3. Any subject who has received any of the following medications prior to the start of the screening period (Visit 1) or prior to the study start period (Visit 4) (see Section 4.7.2 for further details):
    ◦ Concurrent use of any medicinal products, or herbal or over-the-counter (OTC) preparations licensed for control of body weight or appetite at the time of screening (Visit 1)
    ◦ Concurrent or previous use of drugs approved for weight loss (eg, orlistat, bupropion-naltrexone, phentermine-topiramate, phentermine, lorcaserin) within the last 30 days or 5 half-lives of the drug (whichever is longest) at the time of screening (Visit 1)
    ◦ Concurrent use of aspirin (acetylsalicylic acid) at a dose greater than 150 mg once daily and within the last 72 hours prior to the start of the study (Visit 4)
    ◦ Concurrent use of paracetamol (acetaminophen) or paracetamol-containing preparations at a total daily dose of greater than 3000 mg and within the last 72 hours prior to the start of the study (Visit 4)
    ◦ Concurrent use of ascorbic acid (vitamin C) supplements at a total daily dose greater than 1000 mg and within the last 72 hours prior to the start of the study (Visit 4)
    ◦ Concurrent use of opiates, domperidone, metoclopramide, or other drugs known to alter gastric emptying and within the last 72 hours prior to the start of the study (Visit 4)

    4. Concurrent participation in another study of any kind and repeat randomization in this study is prohibited

    5. Severe allergy/hypersensitivity to any of the proposed study treatments or excipients

    6. Diagnosis of type 1 diabetes mellitus, maturity-onset diabetes of the young, or latent autoimmune diabetes of adulthood or presence of anti-glutamic acid decarboxylase, anti-islet cell, or anti-insulin antibodies

    7. Symptoms of acutely decompensate blood glucose control (eg, thirst, polyuria, weight loss) at screening or randomization, a history of DKA, or hyperosmolar nonketotic coma or treatment with daily SC insulin within 90 days prior to screening

    8. Fasting hyperglycemia (> 250 mg/dL/ > 13.9 mmol/L) prior to randomization

    9. C-peptide level < lower limit of normal (LLN)

    10. History of acute or chronic pancreatitis or pancreatectomy

    11. Hypertriglyceridemia (> 400 mg/dL) at screening

    12. Significant inflammatory bowel disease, gastroparesis, or other severe disease or surgery affecting the upper gastrointestinal (GI) tract (including weight-reducing surgery and procedures) which may affect gastric emptying or could affect the interpretation of safety and tolerability data

    13. Significant hepatic disease (except for nonalcoholic steatohepatitis or nonalcoholic fatty liver disease without portal hypertension or cirrhosis) and/or subjects with any of the following results at screening:
    • Aspartate transaminase (AST) ≥ 3 × upper limit of normal (ULN)
    • Alanine transaminase (ALT) ≥ 3 × ULN
    • Total bilirubin (TBL) ≥ 2 × ULN

    14. Impaired renal function defined as estimated glomerular filtration rate (eGFR) ≤ 60 mL/minute/1.73m2 at screening (eGFR according to Modification of Diet in Renal Disease [MDRD] using the isotope dilution mass spectrometry-traceable MDRD Study Equation (SI units).

    15. Use of loop diuretics within 1 month prior to screening

    16. Poorly controlled hypertension as defined below:
    • Systolic BP > 160 mm Hg
    • Diastolic BP or ≥ 100 mm Hg
    After 10 minutes of supine rest and confirmed by repeated measurement at screening (Visit 1 for all subjects)

    17. Subjects with a history of unstable angina pectoris, myocardial infarction, transient
    ischemic attack, or stroke, or subjects who have undergone percutaneous coronary
    intervention or a coronary artery bypass graft or who are due to undergo these procedures
    at the time of screening

    18. Severe congestive heart failure (New York Heart Association Class III and IV)

    19. Basal calcitonin level > 50 ng/L at screening or history/family history of medullary thyroid carcinoma or multiple endocrine neoplasia
    E.5 End points
    E.5.1Primary end point(s)
    • Change from baseline (Day -1) to the end of 28 days of treatment (Day 28) in glucose AUC from zero to 4 hours (AUC0 4h) as measured by a MMTT

    • Percentage change from baseline (Day -1) to the end of 28 days of treatment (Day 28) in glucose AUC0 4h as measured by a MMTT
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 28
    E.5.2Secondary end point(s)
    • Incidence of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)

    • Clinically important changes in 12 lead electrocardiogram (ECG), vital signs (including 24-hour heart rate and blood pressure), physical examination, and clinical laboratory evaluations

    •PK profile of both MEDI0382 and dapagliflozin administered simultaneously and dapagliflozin administered with placebo include AUC0-inf, AUC0-last and AUCtau, Cmax, tmax, t1/2, and Cl/F

    • Immunogenicity as measured by the presence of antidrug antibodies (ADA) to MEDI0382 (and titer if positive) during dosing and follow up periods

    • Change from baseline to the end of dosing at each dose level (Days 7, 14, and 28) in glucose AUC at 24 hours (AUC24h) as measured by CGM

    • Change from baseline to the end of dosing at each dose level (Days 7, 14, and 28) in 24 hour mean glucose as measured by CGM

    • Change from baseline to the end of dosing at each dose level (Days 7, 14, and 28) in standard deviation (SD) of 24 hour glucose readings as measured by CGM

    • Change from baseline to Days 7, 14, and 28 in the coefficient of variation (CV) (ratio of SD:mean over 24 hours) of glucose readings as measured by CGM

    • Change from baseline to Days 7, 14, and 28 in the mean amplitude of glucose excursion (MAGE) of 24-hour glucose readings as measured by CGM

    • Change from baseline to Days 7, 14, and 28 in the percentage of 24 hour glucose readings obtained from CGM that fall within the euglycemic range of ≥ 70 mg/dL (≥ 3.9 mmol/L) and ≤ 180 mg/dL (≤ 10.0 mmol/L)

    • Change from baseline to Days 7, 14, and 28 in the percentage of 24-hour glucose readings obtained from CGM that fall within hyperglycemic (high glucose) range of > 180 mg/dL (> 10.0 mmol/L)

    • Change from baseline to Days 7, 14, and 28 in the percentage of 24 hour glucose readings obtained from CGM that fall within the hypoglycemic range of < 70 mg/dL (< 3.9 mmol/L)

    • Change from baseline to Days 7, 14, and 28 in the percentage of 24 hour glucose readings obtained from CGM that fall within the clinically significant hypoglycemic range of < 54 mg/dL (3.0 mmol/L)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Refer to schedule of treatment period procedures in protocol
    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 Yes
    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, immunogenicity
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months5
    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: 33
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 13
    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 state23
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 46
    F.4.2.2In the whole clinical trial 46
    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 Decision2018-06-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-12-06
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