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    The EU Clinical Trials Register currently displays   31553   clinical trials with a EudraCT protocol, of which   5083   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2008-000465-37
    Sponsor's Protocol Code Number:0524A-082
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2008-04-22
    Trial 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 ConcernedFrance - ANSM
    A.2EudraCT number2008-000465-37
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, 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 Dyslipidemic Patients.
    A.4.1Sponsor's protocol code number0524A-082
    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 SponsorLaboratoires Merck Sharp & Dohme - Chibret
    B.1.3.4CountryFrance
    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 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 nameMK-0524A (ER-Niacin/Laropiprant) 1g/20mg
    D.3.2Product code MK-0524A (ER-Niacin/Laropiprant) 1g/20mg
    D.3.4Pharmaceutical form 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 INNLaropiprant
    D.3.9.2Current sponsor codeMK-0524
    D.3.9.3Other descriptive nameL-000888839-000E
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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.3.9.2Current sponsor codeniacin, ER-niacin
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(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) 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 No
    D.3.11.8Extractive medicinal product No
    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 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
    Dyslipidemia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10020604
    E.1.2Term Hypercholesterolemia
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    E.2.1 Main objective: To evaluate the efficacy of ER niacin/laropiprant 2g relative to placebo on plasma low-density lipoprotein cholesterol (LDL-C) at Week 12 of treatment.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of ER niacin/laropiprant 2g relative to placebo on plasma concentrations of LDL-C, LDL-C/HDL-C, HDL-C, TG, non-HDL-C, Apo B, Apo A-I, Total Cholesterol (TC)/HDL-C, TC, and Lp(a) at Week 12 of treatment in all patients and in certain subgroups of patients (c) To assess the percent of patients with triple control at the end of study defined as meeting the NCEP ATP-III LDL-C goal for risk category, as well as having HDL-C ≥ 50 mg/dL (≥1.29 mmol/L) for women or ≥ 40 mg/dL (≥1.04 mmol/L) for men and TG <150 mg/dL (≤1.69 mmol/L) (d) To evaluate the efficacy of ER niacin/laropiprant 1 g relative to placebo on plasma concentrations of LDL-C, LDL-C/HDL-C, HDL-C, TG, non-HDL-C, and TC in all patients at Week 4 of treatment (e) To evaluate the tolerability and safety of ER niacin/laropiprant 2 g across 12 weeks of treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    General
    1.Patient is male or female ≥18 years of age on day of signing informed consent.
    2.Patient understands the study procedures, alternative treatments available, and risks involved with the study, and voluntarily agrees to participate by giving written informed consent.
    3.Contraception for female patients who are of reproductive potential: a female patient who is of reproductive potential agrees to remain abstinent or use (or have their partner use) if required locally 2 acceptable methods of birth control for the duration of the study. An acceptable method of birth control is defined as: intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, vasectomy.
    NOTE: A female patient who is not of reproductive potential is eligible without requiring the use of contraception. A female patient/subject who is not of reproductive potential is defined as: one who has either 1) reached natural menopause (defined as 6 months of spontaneous amenorrhea with serum FSH levels in the postmenopausal range as determined by the laboratory, or 12 months of spontaneous amenorrhea), 2) 6 weeks post surgical bilateral oophorectomy with or without hysterectomy, or 3) bilateral tubal ligation. NOTE: Patients are permitted to use hormonal contraceptives; however, they are not considered an acceptable form of birth control. Patients using hormonal contraceptives must agree to also use 2 acceptable methods of birth control if locally required as indicated above.
    Protocol-Specific
    4.Patient has been on a stable dose of a protocol specified LMT (simvastatin, atorvastatin, or rosuvastatin alone or combined/coadministered with ezetimibe) for 6 weeks prior to Visit 1 and agrees to continue on the same LMT and dose for the duration of the study.
    NOTE: Patients taking other statins (lovastatin, pravastatin, fluvastatin), bile acid sequestrants, red yeast rice products, prescription omega-3-acid ethyl esthers (e.g., Lovaza™), fibrates or niacin ≥ 250 mg are not eligible.
    5.Patient is deemed appropriate for further lipid modification, defined as meeting one or more of the following lipid criteria: a.Elevated LDL-C defined according to NCEP ATP III risk categories as follows:
    •High Risk (CHD/CHD risk equivalent): ≥100 mg/dL (≥ 2.59 mmol/L) and <130 mg/dL (<3.37 mmol/L)
    •Multiple risk (≥ 2 risk factors): ≥ 130 mg/dL (≥ 3.37 mmol/L) and <160 mg/dL (<4.14 mmol/L)
    •Low risk (0-1 risk factor): ≥160 mg/dL (<4.14 mmol/L)
    Or: b.HDL-C <40 mg/dL (<1.04 mmol/L) in men or <50 mg/dL (<1.29 mmol/L) in women Or: c.TG ≥ 150 mg/dL (≥ 1.69 mmol/L)
    Note: Please see Table 3-1 for recommended retest guidance for TG and LDL-C.
    6.Patient has TG levels ≤ 500 mg/dL (≤ 5.65 mmol/L).
    E.4Principal exclusion criteria
    1.Patient is pregnant, breastfeeding, or expecting to conceive during the study including the 14-day post study follow-up. 2.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. 3.Female patient is expecting to donate eggs during the study, including the 14-day follow-up. 4.Patient has a history or current evidence of any condition, therapy, or lab abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate. 5.Patient is unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study. 6. Patient is currently participating in or has participated in a study with: an investigational compound (non-lipid-modifying) within 30 days of Visit 1, a lipid-modifying compound (investigational or marketed, including statins), within 6 weeks of Visit 1 (fibrate within 8 weeks). 7.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.
    8.Patient has the following exclusionary laboratory values at Visit 1 (see Table 3-1 for ALT/AST/CK recommended retest guidance).
    •Creatinine >2.0 mg/dL (177 micromol/L)
    •LT (SGPT) >1.5 x ULN
    •AST (SGOT) >1.5 x ULN
    •CK >2 x ULN
    9.Patient is at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse.
    10.Patient was <75% compliant during placebo run-in AND, in the opinion of the investigator, is believed to be unable to maintain at least a 75% compliance with dosing during the active treatment period. Prohibited Medical Conditions
    Note: Physician circulars should be followed for the patient’s specific statin therapy.
    11.Patient has chronic heart failure defined by the New York Heart Association (NYHA) Classes III or IV, uncontrolled cardiac arrhythmias, or unstable hypertension (systolic blood pressure > 160 mm Hg or diastolic > 100 mm Hg).
    12.Patient has Type 1 or Type 2 diabetes mellitus and meets one or more of the following criteria: Patient is poorly controlled (HbA1C >8.5% at Visit 1) Patient is newly diagnosed (within 3 months of Visit 1)Patient has recently experienced repeated hypoglycemia or unstable glycemic control. Patient is taking new or recently adjusted antidiabetic pharmacotherapy (with the exception of ± 10 units of insulin) within 3 months of Visit 1. 13.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: 14.Patient has nephrotic syndrome or other clinically significant renal disease. 15.Patient has active peptic ulcer disease within 3 months of Visit 1. 16.Patient has had an episode of gout within 1 year of Visit 1, unless patient is currently taking allopurinol. 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. 9.Patient has history of ileal bypass, gastric bypass or other significant condition associated with malabsorption.
    20. Patient has active or chronic hepatobiliary or hepatic 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 at Visit 1.
    21. Patient is HIV positive.
    Prohibited Medications
    22. Patient is currently taking or has taken bile acid sequestrants, niacin ≥250 mg, red yeast rice products (e.g., Cholestin™), prescription omega-3-acid ethyl esthers (e.g., Lovaza™), or excluded statins (lovastatin, pravastatin, fluvastatin) within 6 weeks of Visit 1, or fibrates within 8 weeks of Visit 1.
    23. Patient is receiving treatment with systemic corticosteroids (intravenous, injected, and oral steroids) OR systemic anabolic agents.
    NOTE: Testosterone supplementation is allowed with a stable regimen for at least 6 weeks prior to randomization (Visit 3). Topical, intra-articular, nasal, inhaled, and ophthalmic steroid therapies are allowed. Intermittent, unplanned use of systemic corticosteroids is acceptable if dose duration does not exceed 14 days. Specific dates of use for intermittent systemic treatment must be recorded appropriately on the eCRF.
    24. Patient consumes more than 3 alcoholic drinks on any given day or more than 14 drinks per week. Definition of alcoholic drink available in the protocol.

    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy parameter is the percent change from baseline in LDL-C following 12 weeks of active treatment.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    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 No
    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.8.3 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA96
    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 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 Patient
    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 months3
    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 months3
    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.1.3Elderly (>=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 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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Dyslipidemic patients on Lipid Lowering Therapy
    F.4 Planned number of subjects to be included
    F.4.1In the member state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 510
    F.4.2.2In the whole clinical trial 1600
    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)
    N/A
    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 Decision2008-05-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-05-30
    P. End of Trial
    P.End of Trial StatusOngoing
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