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    Summary
    EudraCT Number:2016-004115-12
    Sponsor's Protocol Code Number:1002-050
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-04-12
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2016-004115-12
    A.3Full title of the trial
    A Multicenter Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of Bempedoic Acid (ETC-1002) 180 mg
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An open-label extension study to assess the long-term safety and effectiveness of investigational drug bempedoic acid (ETC-1002).
    A.3.2Name or abbreviated title of the trial where available
    CLEAR Harmony OLE
    A.4.1Sponsor's protocol code number1002-050
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03067441
    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 SponsorEsperion Therapeutics, 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 supportEsperion Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationICON Clinical Research
    B.5.2Functional name of contact point1002-040 Project Management
    B.5.3 Address:
    B.5.3.1Street Address7405 Transcanada Hwy, Suite 300
    B.5.3.2Town/ citySt. Laurent, Montreal, Quebec
    B.5.3.3Post codeH4T 1Z2
    B.5.3.4CountryCanada
    B.5.4Telephone number+1215 616 3540
    B.5.5Fax number+1514332-0710
    B.5.6E-mailMartin.Lucas@iconplc.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 nameBempedoic acid 180mg Tablets
    D.3.2Product code ETC-1002
    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 INNBempedoic acid
    D.3.9.1CAS number 738606-46-7
    D.3.9.2Current sponsor codeETC-1002
    D.3.9.3Other descriptive nameESP55016
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number180
    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
    Treatment of high cardiovascular risk patients (heterozygous familial hypercholesterolemia [HeFH] and atherosclerotic cardiovascular diseases [ASCVD]) with hyperlipidemia
    E.1.1.1Medical condition in easily understood language
    Treatment of hyperlipidemia; a condition where there is an excess of lipids (fats e.g. cholesterol ) in the blood, in patients with a high risk of developing heart problems.
    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 21.0
    E.1.2Level LLT
    E.1.2Classification code 10020604
    E.1.2Term Hypercholesterolemia
    E.1.2System Organ Class 100000004861
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10020667
    E.1.2Term Hyperlipidemia
    E.1.2System Organ Class 100000004861
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10051615
    E.1.2Term Atherosclerotic cardiovascular disease
    E.1.2System Organ Class 100000004866
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10057079
    E.1.2Term Heterozygous familial hypercholesterolemia
    E.1.2System Organ Class 100000004850
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To characterize the safety and tolerability of long-term administration of bempedoic acid (ETC-1002) 180 mg
    E.2.2Secondary objectives of the trial
    To characterize the efficacy of long-term administration of bempedoic acid 180 mg/day as assessed by changes in LDL C, HDL C, non-high-density lipoprotein cholesterol (non-HDL C), ApoB, total cholesterol (TC), TG and high-sensitivity C reactive protein (hs CRP) in patients with hyperlipidemia
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Each patient must meet the following criteria to be enrolled in this study:
    1. Successfully completed the parent study (1002-040) and meet both of the following criteria:
    • The patient was compliant with the parent study requirements including study visits, procedures, and investigational medicinal product
    (IMP) in the opinion of the principal investigator.
    • The patient was able to tolerate IMP through the end of the parent study.
    E.4Principal exclusion criteria
    1. Female patient is not willing to use at least 1 acceptable method of birth control during treatment and for an additional 30 days after the end of treatment unless patient is sterilized or postmenopausal;
    a. Menopause is defined as greater than 55 years and ≥1 year without menses, less than 55 years and ≥1 year without menses with follicle-stimulating hormone (FSH) ≥40.0 IU/L, or surgically sterile (including hysterectomy and/or bilateral oophorectomy);
    b. Acceptable methods of birth control include: oral birth control medications; placement of an intrauterine device (IUD) with or without hormones; barrier methods including condom or occlusive cap with spermicidal foam or spermicidal jelly; vasectomized male partner who is the sole partner for this patient; or true abstinence where it is the preferred and usual lifestyle of the patient (not including periodic abstinence such as calendar, ovulation, symptothermal, postovulation methods, or withdrawal).
    2. Patient is pregnant or breastfeeding, or might become pregnant during treatment and/ or within 30 days after the end of treatment
    3. Unreliability as a study participant based on the investigator’s (or designee’s) knowledge of the patient (eg, inability or unwillingness to adhere to the protocol)
    4. Experienced a treatment-related SAE that led to study drug discontinuation in the parent study
    5. Disorder that would interfere with understanding and giving informed consent or compliance with protocol requirements
    6. Have any medical condition that in the opinion of the investigator may affect patient safety or ability to complete scheduled assessments
    7. Patient’s medical condition requires lipid measurement and/or adjustment of background lipid-regulating therapy during the first 12 weeks of study participation
    8. Known sensitivity to any of the products to be administered during dosing
    9. Currently enrolled in another investigational device or drug study (excluding ETC-1002-040), or less than 30 days since ending another investigational device or drug study(s),or receiving or planning to receive other investigational agent(s) during this study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint for this study is patient incidence of AEs
    E.5.1.1Timepoint(s) of evaluation of this end point
    At all clinic visits, investigators will review all safety information including vital signs, AEs, and concomitant medications and will ensure that the collected data are recorded into the appropriate eCRF. Additionally, clinical laboratory samples will be collected and sent for analysis and the investigator will review the results to ensure continued patient safety while participating in the study.
    E.5.2Secondary end point(s)
    • Percent change from baseline in LDL C at Weeks 52 and 78
    • Change from baseline in LDL C at Weeks 52 and 78
    • Percent change from baseline in non-HDL C at Weeks 52 and 78
    • Percent change from baseline in TC at Weeks 52 and 78
    • Percent change from baseline in ApoB at Weeks 52 and 78
    • Percent change from baseline in hs CRP at Weeks 52 and 78
    • Percent change from baseline in TG at Weeks 52 and 78
    • Percent change from baseline in HDL C at Weeks 52 and 78
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline and Weeks 52 and 78
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    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 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 concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA59
    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
    Germany
    Netherlands
    Poland
    United Kingdom
    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
    The study will end when the last patient completes their Week 82 visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months7
    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: 845
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 455
    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 state347
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 845
    F.4.2.2In the whole clinical trial 1300
    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)
    None
    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 Decision2017-08-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-05-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-11-05
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