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    Summary
    EudraCT Number:2011-004983-32
    Sponsor's Protocol Code Number:NK-104-4.02EU
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-02-24
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2011-004983-32
    A.3Full title of the trial
    A 52-Week Open-Label Extension and Safety Study of Pitavastatin in High-Risk Hyperlipidaemia in Childhood, P/266/2011, P/267/2011, P/268/2011
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long term investigation of Pitavastatin for high-cholesterol in children
    A.3.2Name or abbreviated title of the trial where available
    PASCAL402
    A.4.1Sponsor's protocol code numberNK-104-4.02EU
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/263/2011
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorKowa Research Europe, Ltd.
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportKowa Research Europe, Ltd.
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKowa Research Europe, Ltd.
    B.5.2Functional name of contact pointRegulatory Affairs
    B.5.3 Address:
    B.5.3.1Street Address105 Wharfedale Road, Winnersh Triangle
    B.5.3.2Town/ cityWokingham
    B.5.3.3Post codeRG41 5RB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441189229000
    B.5.5Fax number+441189229001
    B.5.6E-mailregulatory@kowa.co.uk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Livazo 1mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderKowa Pharmaceutical Europe Co Ltd
    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 namePitavastatin
    D.3.2Product code NK 104
    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 INNPitavastatin
    D.3.9.1CAS number 147526-32-7
    D.3.9.2Current sponsor codeNK 104
    D.3.9.3Other descriptive namePITAVASTATIN CALCIUM
    D.3.9.4EV Substance CodeSUB20723
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Livazo 2mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderKowa Pharmaceutical Europe Co Ltd
    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 namePitavastatin
    D.3.2Product code NK 104
    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 INNPitavastatin
    D.3.9.1CAS number 147526-32-7
    D.3.9.2Current sponsor codeNK 104
    D.3.9.3Other descriptive namePITAVASTATIN CALCIUM
    D.3.9.4EV Substance CodeSUB20723
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Livazo 4mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderKowa Pharmaceutical Europe Co Ltd
    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 namePitavastatin
    D.3.2Product code NK 104
    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 INNPitavastatin
    D.3.9.1CAS number 147526-32-7
    D.3.9.2Current sponsor codeNK 104
    D.3.9.3Other descriptive namePITAVASTATIN CALCIUM
    D.3.9.4EV Substance CodeSUB20723
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    hyperlipidaemia
    E.1.1.1Medical condition in easily understood language
    increased level of blood cholesterol
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10062060
    E.1.2Term Hyperlipidaemia
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10020603
    E.1.2Term Hypercholesterolaemia
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10016205
    E.1.2Term Familial hyperlipidaemia
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10057099
    E.1.2Term Heterozygous familial hypercholesterolaemia
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10049593
    E.1.2Term Familial hypercholesterolaemia
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    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 assess the safety of pitavastatin 1 mg QD, 2 mg QD, and 4 mg QD in children or adolescent patients with high-risk hyperlipidaemia over a period of 52 weeks.
    E.2.2Secondary objectives of the trial
    The secondary objective of this study is to assess the persistence of efficacy with pitavastatin over 52 weeks by measuring lipid parameters and attainment of American Heart Association (AHA) minimal (130 mg/dL [3.4 mmol/L]) and ideal (110 mg/dL [2.8 mmol/L]) targets for LDL-C.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female ≥6 years of age and <17 years of age at Visit 1;
    2. Have fasting LDL-C levels ≥160 mg/dL (4.1 mmol/L) or LDL-C ≥130 mg/dL (3.4 mmol/L) if any of the following additional risk factors are present:
    • Male;
    • A family history of premature cardiovascular disease defined as a myocardial infarction before age 50 in a second-degree relative or before age 60 in a first-degree relative with at least 1 relative (parent, grandparent, or sibling) affected;
    • Presence of low HDL-C (<45 mg/dL) or high TG (>150 mg/dL);
    • Presence of high lipoprotein(a) (>75 nmol/L);
    • Presence of type 2 diabetes mellitus diagnosed by treating physician according to current guidances; or
    • Presence of hypertension defined as systolic and diastolic blood pressures above the 95th percentile for age and size;
    3. Have not taken any lipid-lowering medications in the 5 weeks prior to screening or in the 4 weeks prior to the lipid qualifying visit at Week -1;
    4. Have been adherent to an appropriate diet for at least 8 weeks;
    5. Females who are post-menarche must not be pregnant or breast feeding and, if sexually active, must be using a reliable form of contraception; and
    6. Written informed consent and assent (if necessary) obtained as required per local regulations.
    E.4Principal exclusion criteria
    1. Unable or unwilling to take study drug;
    2. Fasting TG >400 mg/dL (4.5 mmol/L);
    3. Homozygous familial hypercholesterolaemia;
    4. Other secondary causes of hyperlipidaemia (eg, hypothyroidism, human immunodeficiency virus
    infection, systemic lupus erythematosus, organ transplantation, previous malignancy, nephrotic
    syndrome, glycogen storage disease);
    5. Previous history of statin intolerance, adverse effects with other statin use, or hypersensitivity to any
    components of the study drug;
    6. Need for non-statin lipid-lowering medications;
    7. Apheresis therapy;
    8. Use of any concomitant medication which may interfere with the objectives of the study;
    9. Type 1 diabetes mellitus;
    10. Poorly controlled type 2 diabetes mellitus defined as haemoglobin A1c >9.0% at screening;
    11. Severe renal impairment defined as serum creatinine >2.0 mg/dL at screening;
    12. Uncontrolled hypertension;
    13. Untreated thyroid disease;
    14. Severe hepatic impairment, active liver disease, or persistent elevation of alanine transaminase or
    aspartate transaminase >3 × the upper limit of normal (ULN);
    15. Active muscle disease or creatine kinase >3 × ULN (unless explained by exercise);
    16. Screening laboratory values within the following age/gender appropriate reference ranges as assessed
    by the central laboratory:
    • Haemoglobin <10 g/dL for males or <9 g/dL for females or
    • Alkaline phosphatase >2 × ULN for age;
    17. Any other laboratory abnormality that could compromise patient safety because of study
    participation;
    18. Malignancy during the past 5 years;
    19. Current smoker or history of drug or alcohol abuse;
    20. Hospitalisation for any cause within 30 days prior to the administration of study drug;
    21. History of major surgery in the 3 months prior to screening;
    22. Any medical condition which, in the judgment of the Investigator, would jeopardize the evaluation of
    safety and/or constitute a significant safety risk to the patient; or
    23. Participation in another clinical study involving an investigational drug during the course of this
    study or within 30 days prior to signing the informed consent/assent form for this study.
    E.5 End points
    E.5.1Primary end point(s)
    • Adverse events;
    • Clinical laboratory parameters (including assessment of renal function and
    adrenal, gonadal, and pituitary hormones);
    • Vital signs;
    • Electrocardiogram (ECG) parameters; and
    • Physical examinations (including Tanner staging).
    E.5.1.1Timepoint(s) of evaluation of this end point
    see above
    E.5.2Secondary end point(s)
    • Percent change in LDL-C from baseline over 52 weeks of treatment;
    • Percentages of patients who achieve AHA minimal (130 mg/dL [3.4 mmol/L]) and ideal (110 mg/dL [2.8 mmol/L]) LDL-C targets over 52 weeks of treatment;
    • Percent changes in HDL-C, non-high-density lipoprotein cholesterol (non-HDL-C), TC, TG, apolipoprotein A1 (Apo A1), and Apo B from baseline over 52 weeks of treatment; and
    • Changes in TC:HDL-C ratio, non-HDL-C:HDL-C ratio, and Apo B:Apo A1 ratio from baseline over 52 weeks of treatment.
    E.5.2.1Timepoint(s) of evaluation of this end point
    every visit
    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 Yes
    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 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 Yes
    E.8.2.3.1Comparator description
    a different dose of the same product (1 mg, 2 mg and 4 mg)
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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 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 months9
    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 months9
    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: 120
    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.1.1.5.1Number of subjects for this age range: 60
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 60
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Male or female, ≥6 years and <17 years of age at visit 1
    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 120
    F.4.2.2In the whole clinical trial 120
    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)
    not specified
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Vasculair Research Network (VRN)
    G.4.3.4Network Country Netherlands
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-02-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-04-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-05-28
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