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    Summary
    EudraCT Number:2010-021627-27
    Sponsor's Protocol Code Number:MK-0524A-133
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-12-29
    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 ConcernedItaly - Italian Medicines Agency
    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 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 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.
    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 pointDavid Detoro
    B.5.3 Address:
    B.5.3.1Street AddressGCTM, K15-2310, 2000 Galloping Hill Road
    B.5.3.2Town/ cityKenilworth
    B.5.3.3Post codeNJ 07033
    B.5.3.4CountryItaly
    B.5.4Telephone number+1-908-740-2381
    B.5.5Fax number+1 732 594 2740
    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 AuthorisationUnited Kingdom
    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 571170779
    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
    Ipercolesterolemia primaria o dislipidemia mista
    E.1.1.1Medical condition in easily understood language
    High blood cholesterol or high concentration of lipids in the blood
    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 10058110
    E.1.2Term Dyslipidemia
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    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 10027433 - Metabolism and nutrition disorders
    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
    Valutare l'efficacia di ERN/LRPT 2 g rispetto al placebo sul livello plasmatico dell'LDL-C alla settimana 12 del trattamento
    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.
    Valutare l'efficacia di ERN/LRPT 2 g rispetto al placebo sulle concentrazioni plasmatiche di LDL-C:HDL-C, HDL-C, TG, non-HDL-C, Apo B, ApoB:ApoA-I, TC:HDL-C, Lp(a), Apo A-I e TC alla settimana 12 del trattamento
    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):≥80 to <130 mg/dL; ≥2.07 to <3.37 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 <3.37 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; ≥3.37 to <4.14 mmol/L 3. Patient has TG levels <500 mg/dL (<5.65 mmol/L). 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: - Monotherapy: simvastatin or rosuvastatin or atorvastatin - Combination Therapy: ezetimibe/simvastatin in the same tablet - Co-administration Therapy: simvastatin or rosuvas tat in or atorvastatin coadministered 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.
    Specifici per il protocollo: 1. I pazienti devono avere una storia di ipercolesterolemia primaria o dislipidemia mista. 2. I pazienti devono essere conformi a una delle seguenti categorie di rischio e ai corrispondenti criteri per l'LDL-C (le definizioni delle categorie di rischio sono descritte in dettaglio nell'Appendice 6.1) alla visita 2. - Categoria di rischio: Rischio molto elevato Criteri: CHD conclamata o altra patologia vascolare aterosclerotica + altri fattori di rischio multipli o significativi Valore LDL-C accettabile (Visita 2): ≥80 a &lt;130 mg/dl; ≥2,07 a &lt;3,37 mmol/l - Categoria di rischio: Rischio elevato Criteri: Uno dei seguenti: •CHD •rischio equivalente a CHD Valore LDL-C accettabile (Visita 2): ≥100 a &lt;130 mg/dl; ≥2,59 a &lt;3,37 mmol/l - Categoria di rischio: Rischio moderato Criteri: Pazienti non CHD/con rischio non equivalente a CHD con ≥ 2 fattori di rischio e un rischio CHD a 10 anni ≤20% secondo Framingham Valore LDL-C accettabile (Visita 2): ≥130 a &lt;160 mg/dl; ≥3,37 a &lt;4,14 mmol/l. 3. Pazienti con livelli TG &lt;500 mg/dl (&lt;5,65 mmol/l). 4. Pazienti che sono stati in trattamento con una dose stabile di una delle seguenti LMT per almeno 6 settimane prima della visita 1 e accettano di continuare con lo stesso tipo e la stessa dose di LMT per tutta la durata dello studio: • monoterapia: simvastatina, rosuvastatina o atorvastatina; •terapia combinata: ezetimibe/simvastatina nella stessa compressa; •terapia cosomministrata: simvastatina, rosuvastatina o atorvastatina cosomministrata con ezetimibe. Criteri generali 5. Pazienti maschi o femmine con almeno 18 anni al momento della firma del consenso informato. 6. Le pazienti donna devono soddisfare almeno UNO dei seguenti criteri: a. se in eta' fertile, devono accettare di astenersi dall'avere rapporti sessuali o di utilizzare (loro o il loro compagno) 2 metodi contraccettivi accettabili per tutta la durata dello studio. Un metodo contraccettivo accettabile puo' essere: • dispositivo intrauterino (IUD), • diaframma con spermicida, • preservativo, • vasectomia, • contraccettivo orale (pillola, OCP); l'assunzione deve essere iniziata almeno 2 mesi prima della randomizzazione. • spugna contraccettiva (con spermicida); accettabile come uno dei metodi contraccettivi, ma deve essere combinato a uno dei seguenti: dispositivo intrauterino (IUD), diaframma, preservativo o vasectomia. b. Le donne non in eta' fertile non devono usare un anticoncezione per essere eleggibili. Una donna non in eta' fertile e' definita come una donna che si trova in una delle condizioni seguenti: o Ha raggiunto la menopausa naturale, definita come 6 mesi di amenorrea spontanea con livelli di FSH sierici (Visita 1) nell'intervallo di postmenopausa (secondo il laboratorio centrale) oppure 12 mesi di amenorrea spontanea. L'amenorrea spontanea non include i casi in cui esiste una malattia sottostante che causi l'amenorrea (per es. l'anoressia nervosa). o E' stata sottoposta, almeno 6 settimane prima, a un intervento chirurgico di isterectomia o di ooforectomia bilaterale con o senza isterectomia. o E' stata sottoposta a un intervento chirurgico di legatura bilaterale delle tube senza successiva procedura ricostruttiva. 7. Pazienti in grado di comprendere tutte le procedure, i trattamenti alternativi disponibili e i rischi legati allo studio e decidere volontariamente se partecipare o meno alla sperimentazione, fornendo un consenso informato scritto.
    E.4Principal exclusion criteria
    Protocol-Specific: 1. Pt has taken a prohibited LMT within 6 weeks of V1. Examples of prohibited LMT include pravastatin, lovastatin, fluvastatin, bile acid sequestrants, fibrates (monotherapy, co-administration or combination with other LMT), niacin >50 mg, and red yeast rice products. 2. Pt has had a change to the type or dose of acceptable LMT regimen within 6 weeks of V1. General: 3. Pt is pregnant, breastfeeding, or expecting to conceive during the study including the 14-day poststudy follow-up. 4. Pt 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 pt is expecting to donate eggs during the study, including the 14-day follow-up. 6. Pt is unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study. 7. Pt has participated in a study, including post-study follow-up, with an investigational compound (non-lipid-modifying) within 30 days of V1 or a lipidmodifying compound (investigational or marketed), within 6 weeks of V1. 8. Pt 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 V2 (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. Pt has used recreational or illicit drugs within 1 year of signing informed consent. 11. Pt was <80% compliant with LMT or placebo at V2, 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. Pt 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. Pt has Type 1 or Type 2 diabetes mellitus and meets one or more of the following criteria: - Pt is poorly controlled (HbA1C >8.0% at V1) - Pt is newly diagnosed (within 3 months of V1) - Pt has recently experienced repeated hypoglycemia or unstable glycemic control (within 3 months of V1). - Pt is taking new or recently adjusted antidiabetic pharmacotherapy (with the exception of ± ≤10 units of insulin) within 3 months of V1. 14. Pt 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. Pt has nephrotic syndrome or other clinically significant renal disease. 16. Pt has active peptic ulcer disease within 3 months of V1. 17. Pt has a history of hypersensitivity or allergic reaction to niacin or niacincontaining products. 18. Pt has history of myocardial infarction, stroke, coronary artery bypass surgery or other revascularization procedure, unstable angina or angioplasty within 3 months of V1. 19. Pt has arterial bleeding. 20. Pt has a history of ileal bypass, gastric bypass or other significant condition associated with malabsorption or rapid weight loss within 18 months of V1. 21. Pt has active or chronic hepatobiliary or hepatic disease. Prohibited Concomitant Medications: 22. Pt is Chinese and is on simvastatin 80 mg or a product containing simvastatin 80 mg at V1. 23. Pt is receiving treatment with systemic steroids (intravenous, injected, and oral steroids) OR systemic anabolic agents. For the other exclusion criteria please refer to the protocol
    Specifici per il protocollo: 1.Pz che hanno assunto una LMT vietata nelle 6 sett. precedenti la v1. Esempi di LMT vietate includono pravastatina, lovastatina, fluvastatina, sequestranti degli acidi biliari, fibrati (monoterapia, cosomministrazione o combinazione con altre LMT), niacina &gt;50 mg, e prodotti a base di lievito di riso rosso. 2.Pz che hanno modificato il tipo o il dosaggio della LMT permessa nelle 6 sett. che precedono la v1. Criteri generali 3.Pz incinte, che allattano o che stanno programmando una gravidanza durante lo studio, compresi i 14 gg di follow-up post studio. 4.Pz con una anamnesi di tumore maligno sviluppato nei 5 anni precedenti la firma del consenso informato, a eccezione di tumori delle cellule basali o squamose della pelle o di carcinomi della cervice in situ adeguatamente trattati. 5.Donne che intendono donare ovuli durante lo studio, compresi i 14 gg di follow-up post studio. 6.Pz che difficilmente riuscirebbero ad aderire alle procedure dello studio, rispettare gli appuntamenti o che stanno programmando di trasferirsi durante lo studio. 7.Pz che hanno partecipato a uno studio, compreso il follow-up post studio, con un farmaco sperimentale (non lipido-modificante) nei 30 gg precedenti la v1 o con un composto lipido-modificante (sperimentale o in commercio) nelle 6 sett. precedenti la v1. 8.Pz che hanno donato e/o ricevuto sangue come indicato di seguito: •pz che hanno donato prodotti ematici o sono stati sottoposti a flebotomia &gt; 300 ml nelle 8 sett. che precedono la firma del consenso informato. •pz che intendono donare prodotti ematici durante lo studio; •pz che intendono donare piu' di 250 ml di prodotti ematici nelle 8 sett. dopo l'ultima visita dello studio. 9.Pz con i seguenti valori di laboratorio che escludono la partecipazione allo studio alla v2 (la tabella 3.1 indica le linee guida per la ripetizione delle analisi). •Clearance della creatinina (eGFR) &lt;30 ml/min (0,50 ml/s) •ALT (SGPT) &gt;1,5 x ULN •ALT (SGOT) &gt;1,5 x ULN •CK &gt;2 x ULN 10.Pz che hanno assunto stupefacenti o farmaci illegali nell'anno precedente la firma del consenso firmato. 11.Pz con una compliance inferiore all'80% alla LMT o al placebo nella v2 e che, secondo il giudizio del medico, non sono in grado di mantenere una compliance al dosaggio almeno dell'80% durante il periodo di trattamento attivo. Condizioni mediche vietate 12.Pz affetti da insufficienza cardiaca cronica, come definita dalla New York Heart Association (NYHA) Classe III o IV, aritmie cardiache non controllate o ipertensione scarsamente controllata (pressione sistolica &gt;160 mm Hg o diastolica &gt;100 mm Hg). 13.Pz affetti da diabete mellito di Tipo 1 o Tipo 2 e che soddisfano uno dei seguenti criteri: •pz scarsamente controllati (HbA1C &gt;8,0% alla v1); •pz con nuova diagnosi (nei 3 mesi precedenti la v1); •pz che recentemente hanno sperimentato ipoglicemia ripetuta o controllo glicemico non stabile (nei 3 mesi precedenti la v1); •pz che assumono una farmacoterapia antidiabetica nuova o modificata recentemente (tranne nel caso di ± ≤ 10 unita' di insulina) nei 3 mesi precedenti la v1. 14.Pz affetti da patologia endocrina o metabolica non controllata in grado di influenzare i livelli sierici di lipidi o di lipoproteine (cioe', cause secondarie di iperlipidemia, quali iper o ipotiroidismo) 15.Pz affetti da sindrome nefrotica o altra patologia renale clinicamente significativa. 16.Pz con ulcera peptica attiva nei 3 mesi che precedono la v1. 17.Pz con una storia di ipersensibilita' o reazione allergica alla niacina o ai prodotti che contengono niacina. 18.Pz con un’anamnesi di infarto miocardico, ictus, intervento di bypass coronarico o altra procedura di rivascolarizzazione, angina instabile o angioplastica nei 3 mesi che precedono la v1. 19.Pz con emorragia arteriosa. Per gli altri criteri di esclusione far riferimento al protocollo.
    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.
    Endopint di efficacia: Lo scostamento percentuale dal valore basale del livello di LDL-C dopo 12 settimane di trattamento attivo Eendpoint esplorativi: Lo scostamento percentuale dal valore basale nell'hsCRP e la percentuale di pazienti che raggiungono i livelli target per i parametri lipidici LDL-C, HDL-C e TG (secondo entrambi i criteri NCEP ATP III ed ESC) e LDL-C, non-HDL-C e Apo B (secondo le linee guida ADA/ACC), le sottofrazioni di lipoproteine, i proteomi esplorativi e le analisi del DNA. L'analisi a posteriori puo' essere eseguita usando i campioni dei biomarcatori.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    12 settimane
    E.5.2Secondary end point(s)
    Secondary endpoints include the percent change from baseline in LDLC:
    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).
    Secondary endpoints include the percent change from baseline in LDLC:
    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
    12 settimane
    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
    Tollerabilita'
    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 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
    Canada
    China
    Colombia
    India
    Mexico
    New Zealand
    Peru
    Philippines
    Russian Federation
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months10
    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.1.1Number of subjects for this age range: 0
    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: 1000
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 424
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 590
    F.4.2.2In the whole clinical trial 1424
    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
    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 Decision2011-08-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-23
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2013-01-11
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