E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Dyslipidemia |
Dislipidemia |
|
E.1.1.1 | Medical condition in easily understood language |
Abnormal amounts of lipids in the blood |
Aumento anomalo di lipidi nel sangue |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10058110 |
E.1.2 | Term | Dyslipidemia |
E.1.2 | System Organ Class | 100000004861 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020604 |
E.1.2 | Term | Hypercholesterolemia |
E.1.2 | System Organ Class | 100000004861 |
|
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 describe the safety and tolerability of long-term administration of evolocumab. |
- Descrivere la sicurezza e la tollerabilità dell'utilizzo a lungo termine di evolocumab |
|
E.2.2 | Secondary objectives of the trial |
- To describe the effects of long-term administration of evolocumab on low density lipoprotein cholesterol (LDL-C) levels.
- To describe the effects of long-term administration of evolocumab in subjects achieving LDL-C level of < 40 mg/dL (1.03 mmol/L). |
- Descrivere gli effetti a lungo termine della somministrazione di evolocumab sui livelli delle lipoproteine del colesterolo a bassa densità (C-LDL) |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Subject has provided informed consent prior to initiation of any study specific activities/procedures
- Subject had completed FOURIER while still receiving assigned Investigational Product |
- I soggetti hanno viene fornito un consenso informato prima dell'inizio di qualsiasi studio specifico, attività o procedura
- I soggetti hanno completato lo studio FOURIER al momento della nuova somministrazione del farmaco |
|
E.4 | Principal exclusion criteria |
- Permanent discontinuation of Investigational Product during FOURIER for any reason including an adverse event or serious adverse event
-Currently receiving treatment in another investigational device or drug study, or less than 4 weeks since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded
- Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and investigator’s knowledge
- History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
- Subject has known sensitivity to any of the active substances or excipients (eg. carboxymethylcellulose) to be administered during dosing
- Females who are pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 15 weeks after treatment discontinuation
- Female subjects of childbearing potential unwilling to use one acceptable method of effective contraception during treatment and for an additional 15 weeks after the last dose of protocol-required therapies. |
- La sospensione permanente della somministrazione del prodotto durante lo studio FOURIER per qualsiasi reazione o evento avverso
- Attualmente ricevono un trattamento con un altro dispositivo o farmaco in studio, o sono trascorse meno di 4 settimane dalla fine del trattamento con un altro dispositivo o farmaco in studio. Non è possibile la partecipazione ad altre procedure durante la partecipazione allo studio.
- I soggetti non sono in grado di fornire la disponibilità per completare tutte le visite o procedure richieste dal protocollo, e/o di rispettare tutte le procedure al fine di ottenere i migliori risultati per il soggetto e per le ricerche dello sperimentatore
- Storia o evidenza di qualsiasi altro disturbo clinicamente significativo, condizione o malattia, che a giudizio dello sperimentatore o del medico Amgen, se consultato, potrebbero rappresentare un rischio per la sicurezza del soggetto o interferire con la valutazione dello studio, le procedure o il suo completamento
- I soggetti hanno mostrato sensibilità a qualsiasi delle sostanze attive o degli eccipienti ( es. Carbossimetilcellulosa) somministrati durante il dosaggio
- Donne in stato di gravidanza o che programmano una gravidanza o che allattano durante il trattamento e per utleriori 15 settimane dopo la sospensione del farmaco
- Soggetti di sesso femminile in età fertile che non utilizzano metodi contraccettivi durante il trattamento e per ulteriori 15 settimane dopo l'ultima dose della terapia richiesta dal protocollo |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Subject incidence of adverse events |
incidenza nei soggetti di rezioni avverse |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
260 weeks (approximately 5 years) |
260 settimane (approsimativamente 5 anni) |
|
E.5.2 | Secondary end point(s) |
- Percent change of LDL-C from baseline at each scheduled yearly visit
- Achievement of an LDL-C < 40 mg/dL(1.03 mmol/L) at each scheduled yearly visit |
Variazione percentuale di LDL-C dalla linea di base ad ogni visita annuale programmata
- Conseguimento di un LDL-C <40 mg / dl (1,03 mmol / l) ad ogni visita annuale programmata |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Baseline and each scheduled yearly visit |
in linea di base ogni programmata visita annuale |
|
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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
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 | No |
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 | 9 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 109 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
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 | 5 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |