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    Summary
    EudraCT Number:2004-000775-34
    Sponsor's Protocol Code Number:01-04-TL-475-002
    National Competent Authority:Estonia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2004-11-26
    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 ConcernedEstonia - SAM
    A.2EudraCT number2004-000775-34
    A.3Full title of the trial
    A double-blind, randomised, parallel group study to evaluate the safety, tolerability and efficacy of TAK-475 alone or co-administered with atorvastatin in patients with primary dyslipidemia
    A.3.2Name or abbreviated title of the trial where available
    Not available
    A.4.1Sponsor's protocol code number01-04-TL-475-002
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberNot applicable
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorTakeda Europe R&D Centre 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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameTAK-475
    D.3.2Product code TAK-475
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeTAK-475
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeSqualene Synthase Inhibitor
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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.2.1.1.1Trade name Sortis
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Germany
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameSortis
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNatorvastatin
    D.3.9.1CAS number 134523-00-5
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product Information not present in EudraCT
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeHMG-CoA reductase inhibitor
    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 placeboTablet
    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
    Treatment of patients with primary dyslipidemia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7
    E.1.2Level PT
    E.1.2Classification code 10058108
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the overall safety and tolerability of once-daily dosing of 100 mg TAK-475 alone, once-daily dosing of 100 mg TAK-475 co-administered with 10 mg atorvastatin and once-daily dosing of atorvastatin alone over 96 weeks of treatment in patients with primary dyslipidemia.
    E.2.2Secondary objectives of the trial
    To assess the fasting blood lipid profiles of once-daily dosing of 100 mg TAK-475 alone, once-daily dosing of 100 mg TAK-475 co-administered with 10 mg atorvastatin and once-daily dosing of atorvastatin alone over 96 weeks of treatment in patients with primary dyslipidemia
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    At Screening Visit 1 in order to be eligible for enrolment patients must be/have:·

    Male or female aged ≥ 18 years.

    History of dyslipidemia (fasting LDL-C levels ≥ 160 mg/dL (4.15 mmol/L) and triglycerides < 400 mg/dL (4.52 mmol/L) within 30 days prior to screening. These results should be confirmed at screening

    Female patients of child-bearing age must have undergone surgical sterilisation, hysterectomy, tubal ligation, bilateral oophorectomy or be post menopausal women (defined as amenorrhoea > 1yr due to menopause)·

    In good physical and mental health as determined by a physician on the basis of medical history, physical examination and laboratory results·

    Read and understood the Patient Information Sheet and signed the Informed Consent Form

    At Visit 2/2.1 during the Dietary Run-In period patients must be/have:· Fasting LDL-C levels ≥ 130 mg/dL (3.37 mmol/L) <190mg/dL (4.92mmol/L) and triglycerides < 400 mg/dL (4.52 mmol/L)At Randomisation Visit 3 in order to be randomised patients must have fulfilled the above criteria and have:·

    A LOCS III assessment of nuclear opalescence less than or equal to 3.0, cortical cataract less than or equal to 2.0, posterior subcapsular cataract less than or equal to 1.0, and nuclear colour less than 3.0
    E.4Principal exclusion criteria
    At Screening Visit 1 to enter the 6-week Dietary Run-In period the patients must not be/have: ·
    Coronary heart disease (CHD) or CHD-risk factors comprised of:

    o Diabetes mellitus Type I or IIo History or presence of myocardial infarction, angina pectoris, unstable angina, coronary angioplasty, coronary or peripheral arterial surgery (bypass graft), aortic aneurysm, transient ischaemic attacks or cerebrovascular accident·

    A body mass index (BMI) < 15 or > 35 kg/m2·

    A history or presence of:

    o Drug abuse (defined as illicit drug use) or a history of alcohol abuse(defined as routinely consumes > 21 units of alcohol per week) within the 2 years previous to screening
    o Uncontrolled hypertension (Stage 2 hypertension defined as mean resting diastolic blood pressure > 100mmHg or mean resting systolic blood pressure > 160mmHg)
    o Uncontrolled hyper- or hypothyroidism or patients whose thyroid replacement therapy was initiated within the last 3 months
    o HIV positive status, liver disease, hepatitis B or Co Malignancy, except patients whose malignancy has been diagnosed as Stage 1 basal or squamous cell carcinoma
    o Heterozygous or homozygous familial hypercholesteroleamia or known Type III hyperlipoproteinaemia (familial dysbetalipoproteinaemia)
    o Fibromyalgia, myopathy, rhabdomyolysis or unexplained muscle pain and/or discontinuation of HMG-CoA reductase inhibitors due to myalgia
    o Trauma to the eye or eye irradiation, glaucoma, iritis, uveitis, prior intraocular surgery, laser surgery to the iris, retinal photocoagulation, or laser trabeculoplasty, corneal opacification or other medial opacities, or has received LASIK refractive surgery within 6 months prior to Screening Visit 1
    o A clinically significant food allergy that would prevent adherence to the specialised diet ·

    Any other serious disease or condition that might affect life expectancy or make it difficult to successfully manage and monitor the patient according to the protocol

    o A known hypersensitivity or history of adverse reaction to atorvastatin or to TAK-475

    o Taken any excluded medication (see Section 9.10) in the 30 days prior to the Screening Visit 1 or be planning to take any for the duration of the study

    o Taking part in another investigational study or have been participating in an investigational study within the 30 days prior to the Screening Visit 1

    o Unable to give written informed consent for any reason

    o An ALT or AST level > 2 times the ULN, active liver disease, jaundice (bilirubin >1.5 times the ULN) or serum creatinine > 135 mmol/l (1.5 mg/dl), CPK > 3 times the ULN.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints for this study include the following safety assessments:
    ocular monitoring findings including LOCS III grades and best corrected visual acuity assessments

    adverse events (AEs)

    Safety laboratory tests, urinalysis, vital signs, physical examination and 12-lead electrocardiogram (ECG).

    Secondary end-points:

    The changes from baseline in fasting blood lipid profiles including LDL-C, TC, HDL-C, TG’s, VLDL-C, Apo A1 and Apo B.

    The following exploratory endpoints will also be evaluated:
    hs-CRP, HDL2, HDL3 and lipoprotein (a).
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    102-103 weeks including a 1 week screening and 6 weeks run-in period
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state43
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 1500
    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 Decision2005-02-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-01-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-04-24
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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