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    Summary
    EudraCT Number:2006-002616-96
    Sponsor's Protocol Code Number:D3561C00087
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2011-09-20
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2006-002616-96
    A.3Full title of the trial
    A phase IIIb, efficacy, and safety study of rosuvastatin in children and adolescents 10 to 17 years of age with heterozygous familial hypercholesterolemia (HeFH): a 12-week, double-blind, randomized, multi-center, placebo-controlled study with a 40-week, open-label, follow-up period.
    A.3.2Name or abbreviated title of the trial where available
    PLUTO
    A.4.1Sponsor's protocol code numberD3561C00087
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/229/2010
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    B.5.2Functional name of contact pointInformation Center
    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 Information not present in EudraCT
    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 nameCRESTOR
    D.3.2Product code AZD4522
    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 INNROSUVASTATIN CALCIUM
    D.3.9.1CAS number 147098-20-2
    D.3.9.2Current sponsor codeAZD4522
    D.3.9.4EV Substance CodeSUB20721
    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: 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 Information not present in EudraCT
    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 nameCRESTOR
    D.3.2Product code AZD4522
    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 INNROSUVASTATIN CALCIUM
    D.3.9.1CAS number 147098-20-2
    D.3.9.2Current sponsor codeAZD4522
    D.3.9.4EV Substance CodeSUB20721
    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: 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 Information not present in EudraCT
    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 nameCRESTOR
    D.3.2Product code AZD4522
    D.3.4Pharmaceutical form Capsule
    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 INNROSUVASTATIN CALCIUM
    D.3.9.1CAS number 147098-20-2
    D.3.9.2Current sponsor codeAZD4522
    D.3.9.4EV Substance CodeSUB20721
    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 Information not present in EudraCT
    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 nameCRESTOR
    D.3.2Product code AZD4522
    D.3.4Pharmaceutical form Capsule
    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 INNROSUVASTATIN CALCIUM
    D.3.9.1CAS number 147098-20-2
    D.3.9.2Current sponsor codeAZD4522
    D.3.9.4EV Substance CodeSUB20721
    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: 5
    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 Information not present in EudraCT
    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 nameCRESTOR
    D.3.2Product code AZD4522
    D.3.4Pharmaceutical form Capsule
    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 INNROSUVASTATIN CALCIUM
    D.3.9.1CAS number 147098-20-2
    D.3.9.2Current sponsor codeAZD4522
    D.3.9.4EV Substance CodeSUB20721
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20 (2x10)
    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 placeboCapsule
    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
    Heterozygous familial hypercholesterolemia (HeFH) is a frequent, inherited disorderof lipoprotein metabolism caused by mutations in the LDL receptor gene. The risk of CHD is approximately 50% by 50 years of age in untreated HeFH. Morphological and functional changes of the arteries are present in hypercholesterolemic children and can predict future CHD, underscoring the importance of aggressive and early treatment of dyslipidemia to prevent premature events in HeFH.
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    MedDRA Classification
    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 this study is to determine the efficacy of once-daily rosuvastatin in reducing LDL-C in children and adolescents aged 10-17 years with HeFH from baseline (Day 0) to the end of the 12-week double-blind treatment period.
    E.2.2Secondary objectives of the trial
    1.The percent change in LDL-C from baseline to Week 6
    2.The percent change in HDL-C, TC, TG, non-HDL-C, LDL-C/HDL-C, TC/HDL-C, non-HDL-C/HDL-C, ApoB, ApoB/ApoA-1, and ApoA-1 for each assigned dose level from baseline to Week 6, and to the end of the double-blind treatment period as compared to placebo
    3.The efficacy of rosuvastatin in achieving the LDL-C goal of <110 mg/dL (percent response rate) after 40 weeks of titration-to-goal dosing.
    4.The safety of each dose level by assessing the incidence and severity of adverse events, abnormal serum laboratory values, and rate of discontinuations due to AEs at Week 12 (vs. placebo) and during the 40-week open label treatment
    5.The effects on urinary protein excretion and estimated glomerular filtration rate
    6.The effect on growth by assessment of height (including linear growth [cm and Standard Deviation Score]) and secondary characteristics of sexual maturation by Tanner Staging at baseline and 52 weeks
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For inclusion in the study dietary lead in and double-blind period, patients must fulfill all of the following criteria:
    1. Provision of written informed consent from a parent or guardian. Communication with the investigator and understanding and compliance with the requirements of the study by the patient and parent or guardian. Statement of assent from the child or adolescent as required by the IRB or IEC according to local regulations and guidelines
    2. Male or female (Tanner stage II to V, at least 1 year post-menarche) children and adolescents (aged 10 –17 years) with heterozygous familial hypercholesterolemia (HeFH)* and at least one of the following criteria:
    - Fasting LDL-C >190 mg/dL (4.9 mmol/L) at Visit 2
    or
    - Fasting LDL-C >160 mg/dL (4.1 mmol/L) at Visit 2 and either of the following:
    - Family history of premature cardiovascular disease (CVD) defined as onset of clinical atherosclerotic disease before age 55 in males or age 65 in females
    or
    - 2 or more other CVD risk factors (HDL-C <35 mg/dL; hypertension; cigarette smoking; severe obesity; diabetes mellitus; physical inactivity) present after vigorous attempts have been made to control these risk factors during 6 weeks dietary lead-in
    *HeFH defined as:
    · Documented genetic defect in LDL receptor or ApoB by DNA analysis
    or
    · Documented evidence of FH in a first degree relative (LDL-C >190 mg/dL (4.9mmol/L) in an adult not receiving a statin or LDL-C >95mg/dL (2.5mmol/L) in an adult receiving statin treatment; LDL-C >160 mg/dL (4.1mmol/L) in a child <18 years of age not receiving a statin or LDL-C >80mg/dL (2.1mmol/L) in a child <18 years of age receiving statin treatment)
    3. Negative serum pregnancy test (b-human chorionic gonadotropin analysis [b-HCG]) prior to randomization and thereafter in females
    · Female patients must adhere to a pregnancy prevention method (abstinence, chemical or mechanical) during the study
    4. Willing to follow all study procedures including adherence to dietary guidelines, study visits, fasting blood draws and compliance with study treatment regimen
    E.4Principal exclusion criteria
    Any of the following is regarded as a criterion for exclusion from the study:
    1. History of statin induced myopathy or serious hypersensitivity reaction to other HMG-CoA reductase inhibitors (statins), including rosuvastatin
    2. Fasting TG ³250 mg/dL (2.87 mmol/L) at Visit 2
    3. Fasting serum glucose of 180 mg/dL (9.99 mmol/L) or HbA1c >9% at Visit 1 or patients with a history of diabetic ketoacidosis within the past 1 year
    4. Uncontrolled hypothyroidism defined as thyroid stimulating hormone (TSH) > 1.5 times the upper limit of normal (ULN) at Visit 1 (Week -6) or patients whose thyroid replacement therapy was initiated or modified within the last 3 months
    5. Use of specified disallowed concomitant medications
    6. History of alcohol abuse and/or drug abuse
    7. Current active liver disease or hepatic dysfunction (excluding a confirmed diagnosis of Gilbert’s disease) as defined by elevations of 1.5 times the ULN for any age in any of the following liver functions tests: ALT, AST, or bilirubin at Visit 1
    8. Serum creatine kinase (CK) ³3 times ULN (unless explained by exercise) at Visit 1
    9. Estimated GFR by Schwartz formula < 50 ml/min at Visit 1 (Schwartz, 1985)
    10. ³2+ proteinuria on urine dipstick at Visit 1 or Visit 2
    11. Stage 2 Hypertension (systolic and/or diastolic blood pressure greater than 5 mmHg above the 99th percentile for age, gender and height, see Appendix H)
    12. History of solid organ transplantation
    13. Patients previously screened for this study and/or patients randomized to treatment who subsequently withdraw consent
    14. Participation in another investigational drug study <4 weeks before enrolment into the dietary lead-in period
    15. Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the patient’s safety or successful participation in the study
    16. Documented history of malignancy with the exception of basal or squamous cell carcinoma of the skin
    17. Patients who are Tanner Stage 1
    18. Boys > 12 years of age with testicular volume <3 cc
    19. Patients with height <3rd percentile for age and sex (See Appendix I)
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint will be the percent change from the baseline in LDL-C at 12 weeks of treatment from each rosuvastatin dose as compared to placebo. Statistically significant results for any dose (without multiplicity adjustment) will be considered acceptable evidence of efficacy if a trend toward dose response is evident.
    E.5.1.1Timepoint(s) of evaluation of this end point
    See E.5.1
    E.5.2Secondary end point(s)
    - Percent of patients achieving a LDL-C target of <2.85 mmol/L during double-blind dose treatment at dose of 5 mg up to 20 mg (week 12)
    - Percent change in LDL-C from baseline to week 6
    - Percent change from baseline in HDL-C, TC, TG, non-HDL-C, LDL-C/HDL-C, TC/HDL-C, non-HDL-C/HDL-C, ApoB, ApoB/ApoA-1 and ApoA-1 to weeks 6 and 12
    - Assessment of growth and secondary characteristics of sexual maturation at baseline and 52 weeks
    E.5.2.1Timepoint(s) of evaluation of this end point
    See E.5.2
    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 Yes
    E.8.1.7.1Other trial design description
    After double blind will become open label
    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 trial4
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Canada
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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.1.1.1In 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.1.1.6Adolescents (12-17 years) Yes
    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 Yes
    F.3.3.2Women of child-bearing potential using contraception No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    subjects are age 10 to 17 years
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 200
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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