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    Summary
    EudraCT Number:2010-021627-27
    Sponsor's Protocol Code Number:MK-0524A-133
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-02-25
    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 ConcernedGermany - BfArM
    A.2EudraCT number2010-021627-27
    A.3Full title of the trial
    A Worldwide, Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled 12-Week Study to Evaluate the Efficacy and Safety of Extended Release (ER) Niacin/Laropiprant When Added to Ongoing Lipid-Modifying Therapy in Patients with Primary Hypercholesterolemia or Mixed Dyslipidemia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A worldwide placebo-controlled study to evaluate the additional lipid benefits of extended release (ER) niacin/laropiprant when taken with current lipid-modifying therapy in individuals with abnormal lipids
    A.4.1Sponsor's protocol code numberMK-0524A-133
    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.,
    B.5.2Functional name of contact pointGlobal Clinical Trial Organisation
    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.5.4Telephone number+1908740-2381
    B.5.5Fax number+1908740-3606
    B.5.6E-maildavid.detoro@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 Yes
    D.2.1.1.1Trade name Tredaptive 1000 mg/20 mg modified-release tablets
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme Ltd., Hoddesdon, UK
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical 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 INNNICOTINIC ACID
    D.3.9.1CAS number 59-67-6
    D.3.9.3Other descriptive namepyridine-3-carboxylic acid
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLAROPIPRANT
    D.3.9.1CAS number 571170-77-9
    D.3.9.2Current sponsor codeMK-0524
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    Primary Hypercholesterolemia or Mixed Dyslipidemia
    E.1.1.1Medical condition in easily understood language
    High blood cholesterol or high concentration of lipids in the blood.
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10058110
    E.1.2Term Dyslipidemia
    E.1.2System Organ Class 100000004861
    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 efficacy of ERN/LRPT 2 g relative to placebo on plasma LDL-C at week 12 of treatment.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of ERN/LRPT 2 g relative to placebo on plasma concentrations of LDL-C:HDL-C, HDL-C, TG, non-HDL-C, Apo B, ApoB:ApoA-I,
    TC:HDL-C, Lp(a), Apo A-I, and TC at Week 12 of treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Protocol-Specific:

    1. Patient has a history of primary hypercholesterolemia or mixed dyslipidemia.

    2. Patient must meet one of the following risk categories and corresponding LDL-C criteria (detailed definitions of risk categories are in Appendix 6.1) at Visit 2.

    Risk Category: Very High Risk
    Criteria: Established CHD or other atherosclerotic vascular disease + other significant or multiple risk factors
    Acceptable LDL-C Value (Visit 2):≥70 to <130 mg/dL; ≥1.81 to <3.36 mmol/L

    Risk Category: High Risk:
    Criteria: One of the following
    CHD
    CHD risk equivalent
    Acceptable LDL-C Value (Visit 2):≥100 to <130 mg/dL; ≥2.59 to <3.36 mmol/L

    Risk Category: Moderate Risk
    Criteria: Non-CHD/Non-CHD Risk Equivalent patient with ≥2 risk factors and Framingham 10-year CHD risk ≤20%
    Acceptable LDL-C Value (Visit 2): ≥130 to <160 mg/dL; ≥3.36 to <4.14 mmol/L

    3. Patient has TG levels <500 mg/dL (<5.65 mmol/L) at Visit 2.

    4. Patient has been on a stable dose of one of the following LMTs for at least 6 weeks prior to Visit 1, and agrees to remain on the same type and dose of LMT for the duration of the study, unless the patient is LMT naive. Patient who is given new therapy (ezetimibe/simvastatin FDC tablet 10/20 mg or rosuvastatin 10 mg or ezetimibe co-administered with any statin) based on investigator’s clinical judgment at Visit 1, must agree to remain on the same type and dose of LMT for the duration of
    the study:
    -Monotherapy: any statin
    -Combination Therapy: ezetimibe/simvastatin FDC tablet
    -Co-administration Therapy: any statin co-administered with ezetimibe

    General:

    5. Patient is male or female and ≥18 years of age on day of signing informed consent.

    6. A female patient must meet ONE of the following:

    a. Of reproductive potential and agrees to remain abstinent or use (or have their partner use) 2 acceptable methods of birth control for the study duration. An acceptable method of birth control is defined as:
    - intrauterine device (IUD)
    - diaphragm with spermicide
    - condom
    - vasectomy
    - oral contraceptive pills (OCPs) – must have been used for at least 2 months prior to randomization.
    - contraceptive sponge (with spermicide) is acceptable as a single method of birth control but requires one of the following as a second method: intrauterine device (IUD), diaphragm, condom or vasectomy.


    b. Not of reproductive potential is eligible without requiring the use of contraception.

    Definition of "not of reproductive potential": one who has either of the
    following:
    - reached natural menopause, defined as: 6 months of spontaneous amenorrhea with serum FSH levels (at Visit 1) in the postmenopausal range (per central lab) or 12 months of spontaneous amenorrhea. Spontaneous amenorrhea does not include cases for which there is an underlying disease that causes amenorrhea (e.g., anorexia nervosa).
    - 6 weeks post surgical hysterectomy, or bilateral oophorectomy with or without hysterectomy.
    - Bilateral tubal ligation without subsequent restorative procedure.

    7. Patient understands the study’s procedures, alternative treatments available, risks involved with the study, and voluntarily agrees to participate by giving written informed consent.
    E.4Principal exclusion criteria
    Protocol-Specific:

    1. Patient has taken a prohibited LMT within 6 weeks of Visit 1. Examples of
    prohibited LMT include bile acid sequestrants, fibrates (monotherapy, coadministration or combination with other LMT), niacin >50 mg, and red yeast rice products.

    2. Patient has had a change to the type or dose of acceptable LMT regimen within 6 weeks of Visit 1.

    General:
    3. Patient is pregnant, breastfeeding, or expecting to conceive during the study including the 14-day poststudy follow-up.

    4. 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.

    5. Female patient is expecting to donate eggs during the study, including the 14-day follow-up.

    6. Patient is unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study.

    7. Patient has participated in a study, including post-study follow-up, with an investigational compound (non-lipid-modifying) within 30 days of Visit 1 or a lipidmodifying compound (investigational or marketed), within 6 weeks of Visit 1.

    8. Patient has donated and/or received blood as follows:

    - donated blood products or has had phlebotomy of >300 mL within 8 weeks prior to signing informed consent.
    - intends to give or receive blood products during the study.
    - intends to donate more than 250 mL of blood products within 8 weeks following the last study visit.

    9. Patient has the following exclusionary laboratory values at Visit 2 (Table 3-1 provides retesting guidelines).
    - Creatinine clearance (eGFR) <30 mL/min (0.50 mL/s)
    - ALT (SGPT) >1.5 x ULN
    - AST (SGOT) >1.5 x ULN
    - CK >2 x ULN

    10. Patient has used recreational or illicit drugs within 1 year of signing informed consent.

    11. Patient was <80% compliant with LMT or placebo at Visit 2, AND in the opinion of the investigator, is believed to be unable to maintain at least 80% compliance with dosing during the active treatment period.

    Prohibited Medical Conditions

    12. Patient has chronic heart failure defined by the New York Heart Association (NYHA) Classes III or IV, uncontrolled cardiac arrhythmias, or poorly controlled hypertension (systolic blood pressure >160 mm Hg or diastolic >100 mm Hg).

    13. Patient has Type 1 or Type 2 diabetes mellitus and meets one or more of the following criteria:
    - Patient is poorly controlled (HbA1C >8.0% at Visit 1)
    - Patient is newly diagnosed (within 3 months of Visit 1)
    - Patient has recently experienced repeated hypoglycemia or unstable glycemic control (within 3 months of Visit 1).
    - Patient is taking new or recently adjusted antidiabetic pharmacotherapy (with the
    exception of ± ≤10 units of insulin) within 3 months of Visit 1.

    14. Patient has uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins (i.e., secondary causes of hyperlipidemia such as hyper- or hypothyroidism:

    15. Patient has nephrotic syndrome or other clinically significant renal disease.

    16. Patient has active peptic ulcer disease within 3 months of Visit 1.

    17. Patient has a history of hypersensitivity or allergic reaction to niacin or niacin containing products.

    18. Patient has history of myocardial infarction, stroke, coronary artery bypass surgery or other revascularization procedure, unstable angina or angioplasty within 3 months of Visit 1.

    19. Patient has arterial bleeding.

    20. Patient has a history of ileal bypass, gastric bypass or other significant condition associated with malabsorption or rapid weight loss within 18 months of Visit 1.

    21. Patient has active or chronic hepatobiliary or hepatic disease.

    Prohibited Concomitant Medications

    22. Patient is Chinese and is on simvastatin 80 mg or a product containing simvastatin 80 mg at Visit 1.

    23. Patient is receiving treatment with systemic steroids (intravenous, injected, and oral steroids) OR systemic anabolic agents.

    24. Patient consumes more than 3 alcoholic drinks on any given day or more than 14 drinks per week. Please see Section 3.2.2 for definition of alcoholic drinks.

    25. Patient is taking the following antioxidant vitamins each day:

    - Vitamin C in excess of 1500 mg
    - Vitamin E in excess of 45 IU for men, 36 IU for women
    - Beta Carotene 15000 IU for men, 12000 IU for women
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy Endpoints:

    Percent change from baseline in LDL-C at Week 12.

    Exploratory Endpoints:

    Percent change from baseline in hsCRP, proportion of patients who achieve LDL-C, HDL-C, and TG target lipid levels (per NCEP ATP III and ESC) and proportion of patients who achieve LDL-C, non-HDL-C, and Apo B targets per ADA/ACC, lipoprotein sub-fractions, exploratory proteomics, DNA, posthoc analysis using biomarker samples.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    E.5.2Secondary end point(s)
    Secondary endpoints include the percent change from baseline in LDL-C:HDL-C, HDL-C, TG, non-HDL-C, Apo B, ApoB:ApoA-I, TC:HDL-C, Lp(a), Apo A-I, and TC, at Week 12 and, with LDL-C added, at Week 4. Also included is the proportion of patients who achieve LDL-C target lipid levels (both NCEP ATP III and ESC targets).
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 weeks
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    tolerability
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA54
    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
    Argentina
    Australia
    Brazil
    Bulgaria
    Canada
    Chile
    Colombia
    Czech Republic
    France
    Germany
    Hungary
    India
    Israel
    Italy
    Mexico
    Netherlands
    New Zealand
    Peru
    Philippines
    Poland
    Russian Federation
    Spain
    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
    last visit of the last subject
    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 months6
    E.8.9.1In the Member State concerned days8
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days12
    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: 612
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 612
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2011-02-25. Yes
    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 state66
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 590
    F.4.2.2In the whole clinical trial 1224
    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)
    There are no plans for further treatment with the study drug by the sponsor after the end of the trial.
    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 Decision2011-03-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2013-01-11
    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
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