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    Summary
    EudraCT Number:2010-023467-18
    Sponsor's Protocol Code Number:CTSUREVEAL1
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-12-23
    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 number2010-023467-18
    A.3Full title of the trial
    HPS 3 / TIMI 55: REVEAL (Randomized EValuation of the Effects of Anacetrapib through Lipid-modification): A large-scale, randomized placebo-controlled trial of the clinical effects of anacetrapib among people with established vascular disease
    HPS 3 / TIMI 55: REVEAL (Studio randomizzato sugli effetti di Anacetrapib sui parametri lipidici): Studio su larga scala, randomizzato, controllato con placebo, sugli effetti clinici di Anacetrapib su pazienti con malattia aterosclerotica.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    HPS 3 / TIMI 55: REVEAL (Randomized study of the Effects of Anacetrapib on colesterol in patients with established vascular disease).
    HPS 3 / TIMI 55: REVEAL (Studio randomizzato sugli effetti di Anacetrapib sui valori del colesterolo in pazienti con malattia aterosclerotica).
    A.3.2Name or abbreviated title of the trial where available
    REVEAL
    REVEAL
    A.4.1Sponsor's protocol code numberCTSUREVEAL1
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN48678192
    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 SponsorCLINICAL TRIAL SERVICE UNIT, UNIVERSITY OF OXFORD
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportOxford University
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportMerck Sharp & Dohme
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationANMCO/Fondazione Italiana lotta alle malattie cardiovasclari
    B.5.2Functional name of contact pointCentro Studi ANMCO
    B.5.3 Address:
    B.5.3.1Street AddressVia La Marmora, 34
    B.5.3.2Town/ cityFirenze
    B.5.3.3Post code50121
    B.5.3.4CountryItaly
    B.5.4Telephone number+39-055-5101211
    B.5.5Fax number-39
    B.5.6E-mailcentrostudi@anmco.it
    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.3.9.2Current sponsor codeMK-0859
    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.IMP: 2
    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 Atorvastatin 20mg
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Ireland Pharmaceuticals
    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 INNATORVASTATIN
    D.3.9.1CAS number 134523-00-5
    D.3.9.2Current sponsor codeAtorvastatin
    D.3.9.4EV Substance CodeSUB05600MIG
    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.IMP: 3
    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 Atorvastatin 20mg
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Ireland Pharmaceuticals
    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 INNATORVASTATIN
    D.3.9.1CAS number 134523-00-5
    D.3.9.2Current sponsor codeAtorvastatin
    D.3.9.4EV Substance CodeSUB05600MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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
    Atherosclerotic cardiovascular disease
    Malattia aterosclerotica cardiovascolare
    E.1.1.1Medical condition in easily understood language
    Atherosclerotic cardiovascular disease
    Malattia aterosclerotica cardiovascolare
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10051615
    E.1.2Term Atherosclerotic cardiovascular disease
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to assess the effect of lipid modification using anacetrapib 100mg daily versus placebo on the time to first ''Major Coronary Event''(defined as the occurrence of coronary death, myocardial infarction or coronary revascularization procedure) during the scheduled treatment period.
    L’obiettivo principale dello studio è valutare l'effetto della modificazione dei valori ematici dei lipidi, ottenuta attraverso la somministrazione di anacetrapib 100mg versus placebo, sui tempi di insorgenza di ''eventi coronarici maggiori'' (definiti come morte coronarica, infarto miocardico o rivascolarizzazione coronarica) durante il periodo di trattamento previsto.
    E.2.2Secondary objectives of the trial
    Secondary objective include assessment of the effects of allocation to anacetrapib versus placebo on: i) coronary death or myocardial infarction (key secondary objective); ii) coronary revascularization procedure; iii) Presumed ischaemic stroke (i.e. not known to be haemorrhagic); and iv) Death from all cardiovascular causes
    Gli obiettivi secondari includono la valutazione degli effetti della somministrazione di anacetrapib versus placebo su: i) morte coronarica o infarto miocardico (obiettivi secondari principali); ii) procedure di rivascolarizzazione coronarica; iii) presunto ictus ischemico (i.e. di cui non si sia a conoscenza se sia emorragico); e iv)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must be aged at least 50 at the time of initial invitation, and at least one of the following inclusion criteria must be satisfied: •History of MI; or •Cerebrovascular atherosclerotic disease (i.e. history of presumed ischaemic stroke or carotid revascularization); or •Peripheral arterial disease (i.e. history of non-coronary revascularization, including aortic aneurysm repair or graft); or • Diabetes mellitus with other evidence of symptomatic coronary heart disease (i.e. treatment or hospitalization for angina, or a history of coronary revascularization or acute coronary syndrome).
    Età ≥50 anni al momento dell'invito ed almeno una delle seguenti condizioni: •Pregresso IMA; •Vasculopatia cerebrale aterosclerotica (i.e. storia di ictus ischemico o presunto ischemico, rivascolarizzazione carotidea); •Vasculopatia periferica (i.e. rivascolarizzazione periferica, intervento per aneurisma dell’aorta); •Diabete mellito con evidenza di cardiopatia ischemica (i.e. terapia o ricoveri per angina, storia di rivascolarizzazione coronarica o di sindrome coronarica acuta).
    E.4Principal exclusion criteria
    None of the following must be satisfied: • Acute MI, acute coronary syndrome or stroke within 4 weeks prior to Screening Visit or during Run-in (but such individuals may be entered later, if appropriate); • Planned coronary revascularization procedure within the next 6 months (such individuals may be entered later, if appropriate); • Definite history of chronic liver disease, or abnormal liver function (i.e. ALT >2x ULN). Note: Individuals with a history of acute hepatitis are eligible provided this ALT limit is not exceeded; • Severe renal insufficiency (i.e. creatinine >200 µmol/L [2.3 mg/dL], dialysis or functioning renal transplant); • Evidence of active inflammatory muscle disease (e.g. dermatomyositis, polymyositis), or CK >3x ULN; • Previous significant adverse reaction to a statin or anacetrapib; • Current treatment with any of the following lipid-lowering treatments: (i) a regimen considered to produce substantially greater LDL cholesterol reduction than atorvastatin 80 mg daily; or (ii) fibric acid derivative (“fibrate”, including gemfibrozil); or (iii) niacin (nicotinic acid) at doses above 100 mg daily • Concurrent treatment with a medication that is contraindicated with anacetrapib or atorvastatin: (i) any potent CYP3A4 inhibitor, such as: (a) macrolide antibiotics (erythromycin, clarithromycin, telithromycin); (b) daptomycin (c) systemic imidazole or triazole antifungals (e.g. itraconazole, posaconazole); (d) protease inhibitors (e.g. atazanavir); (e) nefazodone (ii) ciclosporin (iii) systemic use of fusidic acid Note: Individuals who are taking such drugs temporarily may be re-screened when they discontinue them, if considered appropriate; • Known to be poorly compliant with clinic visits or prescribed medication; • Medical history that might limit the individual’s ability to take trial treatments for the duration of the study (e.g. severe respiratory disease; history of cancer or evidence of spread within last 5 years, other than non-melanoma skin cancer; or recent history of alcohol or substance misuse); • Women of child-bearing potential (unless using adequate contraception); • Current participation in a clinical trial with an unlicensed drug or device. Individuals will also be excluded at the Screening visit if it is considered unlikely that they will achieve total cholesterol <3.5 mmol/L (135 mg/dL) on the highest atorvastatin dose (80 mg daily). In addition, individuals will be excluded at the Randomization visit if any of the following are true: • Total cholesterol above 4 mmol/L • Non-compliant with run-in treatment (<90% scheduled run-in medication taken) • Individual is no longer willing to be randomized into the 4-5 year trial • The individual’s doctor is of the view that their patient should not be randomized.
    Nessuna delle seguenti deve essere presente: •Infarto miocardico, sindrome coronarica acuta o ictus occorsi nelle 4 settimane precedenti la visita di screening o durante il run-in (questi pazienti possono essere rivalutati per l’inclusione successivamente); •Procedure di rivascolarizzazione coronarica programmate nei 6 mesi successivi (questi pazienti possono essere rivalutati per l’inclusione successivamente); •Storia di epatopatia cronica o alterazione dei parametri di funzionalità epatica (i.e. ALT &gt;2 volte il limite superiore di normalità) Nota: possono essere inclusi pazienti con storia di epatite acuta se il valore di ALT rispetta i limiti segnalati; •Insufficienza renale (i.e. creatinina &gt;2.3 mg/dL, trattamento dialitico o trapianto renale); •Presenza di malattie infiammatorie muscolari (es. dermatomiosite, polimiosite), o valori di CK &gt;3 volte il limite superiore di normalità; •Precedenti reazioni avverse alle statine o all’anacetrapib; •Terapia ipolipemizzante con uno dei seguenti regimi farmacologici:  qualsiasi trattamento che possa determinare una riduzione del colesterolo LDL superiore rispetto a quella attesa dalla somministrazione di atorvastatina 80 mg/die o  fibrati (compreso il gemfibrozil); o  niacina (acido nicotinico) con dosi superiori a 100 mg/die •Terapia con farmaci la cui assunzione è controindicata contemporaneamente ad anacetrapib o atorvastatina:  Inibitori del CYP3A4 come: - macrolidi (eritromicina, claritromicina, azitromicina, telitromicina); - daptomicina; - imidazolo o altri antimicotici somministrati per via sistemica; - inibitori delle proteasi (es. atazanavir); - nefazodone;  Ciclosporina;  Acido fusidico somministrato per via sistemica. Nota: tutti i pazienti che assumono uno di questi farmaci temporaneamente possono essere rivalutati al momento in cui interrompono l’assunzione; •Scarsa compliance del paziente sia rispetto alle visite che rispetto alla terapia; •Condizioni che possono limitare la possibilità del paziente a portare a termine lo studio o ad assumere i trattamenti in studio (es. presenza di neoplasie maligne, insufficienza respiratoria grave, abuso di alcool); •Donne in età fertile (a meno di adeguata contraccezione); •Partecipazione in altri studi clinici di trattamento. Se alla visita di screening il medico ritiene che il paziente non abbia probabilità di raggiungere livelli di colesterolo totale &lt;135 mg/dL, neppure con il dosaggio di 80 mg/die di atorvastatina, dovrà escludere il paziente. Inoltre, saranno esclusi i pazienti che, al momento della visita di randomizzazione, presenteranno una delle seguenti condizioni: •Colesterolo totale &gt;155 mg/dL; •Scarsa compliance rispetto al trattamento assegnato nella fase di run-in (&lt;90% di farmaco assunto); •Volontà del paziente a non intraprendere uno studio della durata di 4-5 anni; •Parere contrario alla partecipazione da parte del medico curante.
    E.5 End points
    E.5.1Primary end point(s)
    Major coronary events (defined as the occurrence of coronary death, myocardial infarction or coronary revascularization procedure) during the scheduled treatment period.
    Evento coronarico maggiore (definito come morte per cause coronariche, infarto miocardico o rivascolarizzazione coronarica).
    E.5.1.1Timepoint(s) of evaluation of this end point
    At least 4 years, and until at least 1900 participants have had an unrefuted major coronary event (primary endpoint) plus at least 950 participants have had a coronary death or myocardial infarction (key secondary endpoint).
    Almeno 4 anni di follow-up e fino a che 1900 pazienti saranno andati incontro ad un evento coronarico maggiore (endpoint primario) e in almeno 950 pazienti sarà registrata una morte per cause coronariche o un infarto miocardico (endpoint secondari chiave)
    E.5.2Secondary end point(s)
    (i) Coronary death or myocardial infarction (key secondary outcome); (ii) Coronary revascularization procedure; (iii) Presumed ischaemic stroke (i.e. not known to be haemorrhagic); and (iv) Death from all cardiovascular causes.
    i) Morte coronarica o infarto miocardico ii) rivascolarizzazione coronarica iii) ictus di presunta origine ischemica (i.e. esclusi gli ictus dovuti a emorragia) iv)morte per causa cardiovascolare
    E.5.2.1Timepoint(s) of evaluation of this end point
    At least 4 years, and until at least 1900 participants have had an unrefuted major coronary event (primary endpoint) plus at least 950 participants have had a coronary death or myocardial infarction (key secondary endpoint).
    Almeno 4 anni di follow-up e fino a che 1900 pazienti saranno andati incontro ad un evento coronarico maggiore (endpoint primario) e in almeno 950 pazienti sarà registrata una morte per cause coronariche o un infarto miocardico (endpoint secondari chiave)
    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 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 concerned33
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA190
    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
    China
    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
    Median follow-up of at least 4 years and a minimum of 1900 participants have had at least 1 unrefuted major coronary event (primary endpoint) and a minimum of 950 participants have had at least 1 unrefuted coronary death or MI (key secondary endpoint).
    Follow up medio di 4 anni e almeno 1900 paz. avranno avuto un evento coronarico maggiore (endpoint primario)e almeno 950 paz saranno deceduti per morte coronarica o avranno avuto un infarto miocardico (endpoint secondario).
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months0
    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: 1100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1000
    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 state2100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 14000
    F.4.2.2In the whole clinical trial 30000
    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)
    At the conclusion of the study, all patients will be able to continue with atorvastatin via their GP or consultant. Anacetrapib does not have a marketing authorisation and so will not be available to participants after the study.
    A fine studio tutti i pazienti potranno continuare ad assumere atorvastatina che dovrà essere assegnata dal medico curante. L'anacetrapib invece non ha l'autorizzazione all'immissione in commercio e non sarà pertanto disponibile per i partecipanti a fine studio.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Fondazione per il Tuo cuore ONLUS
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-01-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-15
    P. End of Trial
    P.End of Trial StatusCompleted
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