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    Summary
    EudraCT Number:2011-004525-27
    Sponsor's Protocol Code Number:MK-0859-020
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-11-18
    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 ConcernedUK - MHRA
    A.2EudraCT number2011-004525-27
    A.3Full title of the trial
    A 1-Year, Worldwide, Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Assess the Efficacy and Tolerability of Anacetrapib When Added to Ongoing Statin Therapy With or Without Other Lipid Modifying Medication(s) in Patients with Heterozygous Familial Hypercholesterolemia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomized study to assess efficacy and safety of Anaceptrapib when added to ongoing lipid-lowering therapy.
    A.3.2Name or abbreviated title of the trial where available
    Study of Anaceptrapib in Heterozygous Familial Hypercholesterolemia
    A.4.1Sponsor's protocol code numberMK-0859-020
    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 pointGlobal Clinical Trial Operations
    B.5.3 Address:
    B.5.3.1Street AddressK15-2310, 2000 Galloping Hill Road
    B.5.3.2Town/ cityKenilworth
    B.5.3.3Post codeNJ 07033
    B.5.3.4CountryUnited States
    B.5.6E-mailsanskruti_vaidya@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 nameAnacetrapib
    D.3.2Product code MK-0859
    D.3.4Pharmaceutical form 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 INNAnacetrapib
    D.3.9.1CAS number 875446-37-0
    D.3.9.2Current sponsor codeMK-0859
    D.3.9.4EV Substance CodeAS1
    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) 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 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
    Heterozygous Familial Hypercholesterolemia
    E.1.1.1Medical condition in easily understood language
    High blood cholesterol disorder that is passed down through families
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    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
    1. Evaluate the efficacy of adding anacetrapib 100 mg for 52 weeks relative to placebo on plasma concentrations of LDL-C (beta quantification method).
    2. Evaluate the safety and tolerability of 52 weeks of treatment with anacetrapib 100 mg.
    E.2.2Secondary objectives of the trial
    1. Evaluate the efficacy of adding anacetrapib 100 mg for 52 weeks relative to placebo on plasma concentrations of HDL-C.
    2. Evaluate the efficacy of adding anacetrapib 100 mg for 52 weeks relative to placebo on plasma concentrations of non-HDL-C.
    3. Evaluate the efficacy of adding anacetrapib 100 mg for 52 weeks relative to placebo on plasma concentrations of apo B.
    4. Evaluate the efficacy of adding anacetrapib 100 mg for 52 weeks relative to placebo on plasma concentrations of apo A-1.
    5. Evaluate the efficacy of adding anacetrapib 100 mg for 52 weeks relative to placebo on plasma concentrations of Lp(a).
    6. Evaluate the effects of cessation of anacetrapib 100 mg for 12 weeks on LDL-C, HDL-C, non-HDL-C, apo B, apo A-1, and Lp(a).
    7. Evaluate the safety and tolerability of anacetrapib 12 weeks after cessation of
    treatment.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Future Biomedical Research - see appendix 6.1 of the protocol and separate information sheet/consent form for further details.
    E.3Principal inclusion criteria
    Visit 1
    Patients will be eligible to continue to Visit 2 if they meet the following criteria at Visit 1:
    a. Patient is male or female and ≥18 and ≤80 years of age on day of signing informed consent.
    b. A patient who is of reproductive potential agrees to remain abstinent* or use (or have their partner use) 2 acceptable methods of birth control for the duration of the study. Acceptable methods of birth control are: intrauterine device (IUD), diaphragm with spermicide, condom, vasectomy and hormonal contraception.
    Note: If oral hormonal contraception is used as one of the methods, hormonal contraceptives must have been used for at least 2 months prior to randomization for patients to be eligible for entry into the study.
    A female patient who is not of reproductive potential is eligible without requiring the use of contraception. A female patient who is not of reproductive potential is defined as: one who has either 1) reached natural menopause defined as age 46 or older with a) 12 months of spontaneous amenorrhea or b) 6 months of spontaneous menorrhea with serum FSH levels in the postmenopausal range as determined by the central laboratory, 2) 6 weeks post surgical bilateral oophorectomy with or without hysterectomy, or 3) bilateral tubal ligation.
    *if required locally, two acceptable birth control methods must be used
    a. Patient has been diagnosed with HeFH defined as:
    - Documentation of known mutation in a copy of the patient’s LDL receptor, Apo B, or PCSK9 genes OR
    - In the absence of a genetic diagnosis, a patient must have a documented history of one or more of the following:
    - Documented history of untreated TC >290 mg/dL (7.5 mmol/L) OR
    - untreated LDL-C >190 mg/dL (4.9 mmol/L)
    AND at least ONE of the following:
    -Documented history or presence of a tendinous or cutaneous xanthoma in the patient or a first-degree relative
    - Documented history or presence of a mutated copy of the LDL receptor or apo B gene in an adult first-degree relative or biological offspring
    - Documented history in a first-degree adult relative with untreated TC >350 mg/dL (9.1 mmol/L) or untreated LDL->190 mg/dL (4.9 mmol/L)
    - Documented history in a first degree relative <18 years of age with untreated TC >280 mg/dL (7.2 mmol/L) or LDL-C >160 mg/dL (4.1 mmol/L)
    - Documented history in a first degree relative of premature coronary artery disease or sudden death from natural causes prior to age 55 years if male or prior to age 60 years if female
    b. LDL-C >100 mg/dL (2.59 mmol/L) without documented history of CVD or LDLC >70 mg/dL (1.81 mmol/L) with documented history of CVD
    c. Patients have been treated with an optimal dose of statin (i.e. one of the following) for at least 6 weeks prior to Visit 1:
    - simvastatin 40 mg or 80 mg
    - atorvastatin 20 mg, 40 mg or 80 mg
    - rosuvastatin 5 mg, 10 mg, 20 mg or 40 mg
    - pitavastatin 4 mg
    - lovastatin 80 mg
    - pravastatin 80 mg
    Note: Patients are expected to take statin under supervision of their treating physician in accordance with statin product circular in that region.
    d. Patient has a TG <400 mg/dL (4.52 mmol/L).
    e. Patient has creatine phosphokinase (CPK) ≤2 x upper limit of normal (ULN) [per central laboratory reference ranges].
    f. Patient has alanine aminotransferase (ALT) or aspartate aminotransferase (AST)≤2 x upper limit of normal (ULN) [per central laboratory reference ranges].
    g. Subjects provide written informed consent/assent for the trial. The subject may also provide consent/assent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.
    Note: Patient with laboratory values outside ranges described in the protocol may, at the discretion of the investigator, have ONLY ONE repeat determination performed and if the repeat value satisfies the criterion patient may continue.
    Visit 3
    Patients are eligible for randomization if they meet the following criteria at Visit 3.
    Patient is greater than 75% compliant with study medication during the single-blind placebo run-in phase or in the opinion of the investigator, compliance will improve following additional counseling.
    E.4Principal exclusion criteria
    Visit 1
    Exclusion Criteria Based on Medical History or Laboratory Abnormalities
    a. Patient receives treatment with LDL apheresis within 4 weeks of Visit 1 or expected to undergo treatment with LDL aphresis during the course of the study.
    b. Patient has homozygous familial hypercholesterolemia.
    c. Patient has severe chronic heart failure defined by New York Heart Association (NYHA) Classes III or IV.
    d. Patient has uncontrolled cardiac arrhythmias, MI, PCI, CABG, unstable angina, or stroke within 3 months prior to Visit 1.
    e. Patient has uncontrolled hypertension defined as follows:
    - Sitting diastolic blood pressure ≥100 mmHg, or sitting systolic blood pressure ≥160 mm Hg (non-diabetic patients).
    OR
    - Sitting diastolic blood pressure ≥90 mmHg, or sitting systolic blood pressure ≥150 mm Hg (diabetic patients).
    f. Patient has uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins (i.e., secondary causes of hyperlipidemia).
    Note: Patients with thyroid stimulating hormone (TSH) values outside the central
    laboratory normal range who are determined to be without symptoms of either hypo- or hyperthyroidism may be allowed in the study if, after review by the Investigator and Project Physician, the patient is deemed not to have clinically significant thyroid hormone excess or deficiency.
    g. Patient has active or chronic hepatobiliary, hepatic or gall bladder disease. Note: Patients with chronic hepatitis B or C or non-alcoholic steatosis are allowed in the study if ALT and AST are within protocol-specified range listed in the inclusion criteria.
    h. Patient has eGFR <30 mL/min/1.73m2 based on 4-variable MDRD (Modification
    of Diet in Renal Disease) equation, nephrotic syndrome or other clinically significant renal disease.
    i. Patient has history of mental instability, drug/alcohol abuse within the past 5 years or major psychiatric illness inadequately controlled and unstable.
    j. Patient is pregnant or breast-feeding, or plans to become pregnant during the study or within 2 years after stopping study medication.
    k. Patient has history of ileal bypass, gastric bypass, or other significant condition associated with malabsorption.
    l. Patient is human immunodeficiency virus (HIV) positive (as assessed by medical history).
    m. Patient 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.
    n. Patient has donated blood products or has had phlebotomy of >300 mL within 8 weeks of signing informed consent, or intends to donate 250 mL of blood products or receive blood products within the projected duration of the study.
    o. Patient has a history or current evidence of any condition, therapy, lab abnormality or other circumstance that might confound the results of the study, or interfere with the patient’s participation for the full duration of the study, such that it is not in the best interest of the patient to participate.
    Exclusion Criteria Based on Concomitant Therapy
    p. Patient is currently taking medications that are potent inhibitors or inducers of CYP3A4 (including but not limited to cyclosporine, systemic itraconazole or ketoconazole, erythromycin, clarithromycin, or telithromycin, nefazodone, protease inhibitors, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, St John’s wort) or has discontinued treatment <3 weeks prior to Visit 1. Consumption of >1 liter of grapefruit juice per/day is also prohibited.
    q. Patient is currently participating or has participated in a study with an investigational compound or device within 3 months of signing informed consent.
    r. Patient consumes more than 2 alcoholic drinks per day.
    s. Patient is receiving treatment with systemic corticosteroids.
    Note: Treatment with corticosteroids used as replacement therapy for pituitary/adrenal
    disease is acceptable; however, the patient must be on a stable regimen for at least 6 weeks prior to Visit 1.
    t. Patient is taking systemic anabolic agents.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endopoint is the percentage change from baseline in LDL-C using betaquantification method at Week 52
    E.5.1.1Timepoint(s) of evaluation of this end point
    Multiple timepoints. Please refer to protocol for details.
    E.5.2Secondary end point(s)
    HDL-C, non HDL-C, Apo B, ApoA-I, Lp(a), TC, TC/HDL-C, LDL-C/HDL-C, Apo B/Apo A-1, LDL-C/Apo B, Apo E, and lipoprotein sub-fractions.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Multiple timepoints. Please refer to protocol for details.
    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 No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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) 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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
    Canada
    Czech Republic
    France
    Germany
    Netherlands
    Norway
    Russian Federation
    Spain
    United Kingdom
    United States
    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 years6
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days4
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days4
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state32
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 220
    F.4.2.2In the whole clinical trial 300
    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)
    After the research study stops, participants will no longer receive treatment with the study drug (anacetrapib). They will return to standard of care treatment which their doctor will discuss with them.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-01-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-11-13
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