E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hypercholesterolaemia |
Ipercolesterolemia |
|
E.1.1.1 | Medical condition in easily understood language |
Increased
cholesterol in the blood |
aumento del colesterolo nel sangue |
|
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 | 17.1 |
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 |
|
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 |
To characterize the safety and tolerability of long-term administration of
evolocumab in subjects with known coronary artery disease and hypercholesterolemia |
Caratterizzare la sicurezza e la tollerabilità della somministrazione a lungo termine di evolocumab in soggetti con coronaropatia e ipercolesterolemia note |
|
E.2.2 | Secondary objectives of the trial |
To characterize the efficacy of long-term administration of evolocumab as assessed by LDL-C in
subjects with known coronary artery disease and hypercholesterolemia |
Caratterizzare, sulla base dei livelli di colesterolo LDL, l’efficacia della somministrazione a lungo termine di evolocumab nei soggetti con coronaropatia e ipercolesterolemia note |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects will be eligible for the study if they completed study 20120153. |
Soggetti che saranno eleggibili per lo studio se avranno completato lo studio 20120153 |
|
E.4 | Principal exclusion criteria |
- Did not complete IP in the parent study 20120153
- Have an unstable medical condition, in the judgment of the investigator
- Known sensitivity to any of the products to be administered during dosing
- Currently enrolled in another investigational device or drug study (excluding evolocumab parent study), or less than 30 days since ending another
investigational device or drug study(s),or receiving other investigational agent(s) |
Non completare IP nello studio originario 20120153
- Avere una condizione medica instabile, a giudizio dello sperimentatore
- Sensibilità nota a uno qualsiasi dei prodotti da somministrare durante il dosaggio
- Attualmente arruolati per un altro dispositivo sperimentale o una sperimentazione (ad esclusione studio originario evolocumab), o che sono a meno di 30 giorni dalla conclusione un altro dispositivo sperimentale o di studio di droga (s), o la ricezione di altro agente sperimentale (s) |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Subject incidence of adverse events |
Incidenza di eventi avversi per soggetto |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Day 1, weeks 4, 12, 24, 36, 48, 52, 76 and 104 |
Gli eventi avversi saranno codificati sulla base della versione attuale del MedDRA. L’incidenza per soggetto degli eventi avversi, degli eventi avversi gravi e degli eventi avversi che hanno portato alla sospensione del prodotto sperimentale saranno tabulati per classe di sistemi e organi e termine preferito |
|
E.5.2 | Secondary end point(s) |
LDL-C |
Gli endpoint secondari saranno riepilogati alla settimana 52. A ogni visita programmata, saranno presentate le statistiche descrittive e calcolate le differenze tra le medie di gruppo per gli endpoint secondari |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Week 52 |
Colesterolo LDL alla settimana 52 |
|
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 | No |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 72 |
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 |
Belgium |
Brazil |
Canada |
Chile |
Czech Republic |
Denmark |
France |
Germany |
Greece |
Hungary |
Iceland |
Ireland |
Israel |
Italy |
Korea, Democratic People's Republic of |
Malaysia |
Mexico |
Norway |
Philippines |
Poland |
Russian Federation |
Singapore |
South Africa |
Spain |
Sweden |
Switzerland |
Taiwan |
United Kingdom |
United States |
|
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 7 |
E.8.9.2 | In all countries concerned by the trial days | 0 |