E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hypercholesterolemia therapy in pazients with stabilised high risk ACS and LDL-C levels >= 125 mg/dL (or >= 100 mg/dL if receiving chronic statins) with ezetimibe/simvastatin QD combination compared to simvastatin QD |
Terapia ipocolesterolemizzante in pazienti con ACS stabilizzata ad alto rischio e con livelli di LDL-C >= 125 mg/dL (o >= 100 mg/dL se in trattamento cronico con statine)con combinazione ezetimibe/simvastatina 10mg/40mg PO QD rispetto a simvastatina da sola |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10020603 |
E.1.2 | Term | Hypercholesterolaemia |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
valut il beneficio clinico derivante da un tratt concomb ezetimibe/simvastatina(singole compr di ezetimibe e simvastatina)risp a sola simvastatina,in paz affetti da Sindrome Coronarica Acuta(ACS)sia con Infarto del Miocardio Acuto(IMA)che con angina instabile.Il beneficio clin è def come la riduz del rischio di manifestaz dell'endpoint composito costituito da morte per evento cardiovascolare,eventi coronarici maggiori ed ictus non fatale.Gli eventi coronarici maggiori comprendono IMA non fatale,angina instabile documentata che richieda il ricovero,e tutte le rivascolarizzazioni coronariche sia per via percutanea(PCI)siaattr interventi di bypass coronarico(CABG)avvenuti almeno 30 gg dopo la randomizz.Saranno considerati eventi dell'endpoint clinico solamente gli eventi di rivascolarizz che saranno registrati dopo i primi 30 gg di tratt,allo scopo di evidenziare gli eventi di rivascolarizz che possano aver risentito del tratt e che non siano invece,correlati all'evento di ACS iniziale |
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E.2.2 | Secondary objectives of the trial |
Ob.sec.dello studio sono:a.Valut il beneficio clinico dellacomb ezetimibe/simvastatina,rispetto a simvastatina da sola in paz con ACS stabilizzata,sulla manifestazione dell'endpoint composito di morte dovuto a qualsiasi causa,eventi coronarici maggiori e ictus non fatali;b.Valut il beneficio clinico dellacomb ezetimibe/simvastatina rispetto a simvastatina da sola in paz con ACS stabilizzata,sulla manifestazione dell'endpoint composito di morte dovuta a coronaropatia,IMA non fatale,e rivascolarizzazione coronarica urgente sia con PCI che con CABG che avvengano almeno 30 gg dopo la randomizzazione;c.Valut il beneficio clinico dellacomb ezetimibe/simvastatina rispetto a simvastatina da sola in paz con ACS stabilizzata,sulla manifestazione dell'endpoint composito costituito da morte per eventi cardiovascolari,IMA non fatale,angina instabile documentata che richieda l'ospedalizzazione,tutti gli eventi di rivascolarizzazione avvenuti almeno 30gg dopo la randomizzazione e ictus non fatali. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
PHARMACOGENETIC: Vers: Date: Title: Objectives:
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FARMACOGENETICA: Vers: Data: Titolo: Obiettivi:
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E.3 | Principal inclusion criteria | |
E.4 | Principal exclusion criteria | |
E.5 End points |
E.5.1 | Primary end point(s) |
Endpoint Primari ed Endpoint Primario Composito: Morte CV, Eventi Coronarici Maggiori e Ictus; Morte CV, IMA non fatale, angina instabile documentata che richieda l'ospedalizzazione Tutte le rivascolarizzazioni coronariche sia con PCI che con CABGC, Ictus non fatale |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 100 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 752 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Argentina |
Australia |
Brazil |
Canada |
Chile |
Colombia |
Ecuador |
Hong Kong |
India |
Israel |
Korea, Republic of |
Malaysia |
New Zealand |
Peru |
Singapore |
South Africa |
Taiwan |
Turkey |
Ukraine |
United States |
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E.8.7 | Trial 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
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The study will continue until each subject has been followed for a minimum of 2.5 years and at least one primary endpoint event has been documented in a minimum of 5250 subjects. If at least 5250 subjects do not have at least one documented primary endpoint event within 2.5 years of the completion of enrollment, the study will continue util this number of primary endpoint events has accumulated. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 66 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 66 |
E.8.9.2 | In all countries concerned by the trial days | 0 |