E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hypercholesterolaemia |
Υπερχοληστερολαιμία |
|
E.1.1.1 | Medical condition in easily understood language |
Increased
cholesterol in the blood |
Μη φυσιολογικά επίπεδα χοληστερόλης στο αίμα |
|
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 |
Ο χαρακτηρισμός της ασφάλειας και της ανεκτικότητας της μακροχρόνιας χορήγησης του evolocumab σε ασθενείς με γνωστή στεφανιαία αρτηριακή νόσο και υπερχοληστερολαιμία. |
|
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 |
Ο χαρακτηρισμός της αποτελεσματικότητας της μακροχρόνιας χορήγησης του evolocumab, όπως αξιολογείται μέσω της LDL-C, σε ασθενείς με γνωστή στεφανιαία αρτηριακή νόσο και υπερχοληστερολαιμία. |
|
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. |
Οι ασθενείς θα είναι κατάλληλοι για συμμετοχή στη μελέτη εάν:
1. Έχουν ολοκληρώσει τη μελέτη 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) |
- Δεν ολοκλήρωσε τη θεραπεία με τον ερευνητικό παράγοντα στην αρχική μελέτη 20120153.
- Ο ασθενής έχει μία ασταθή ιατρική πάθηση κατά την κρίση του ερευνητή.
- Γνωστή ευαισθησία σε οποιοδήποτε από τα προϊόντα που πρόκειται να χορηγηθούν κατά τη διάρκεια της δοσολογίας.
- Επί του παρόντος ο ασθενής έχει ενταχθεί σε κάποια άλλη μελέτη ερευνητικού ιατροτεχνολογικού προϊόντος ή φαρμάκου (εξαιρουμένης της αρχικής μελέτης του evolocumab) ή έχουν παρέλθει λιγότερες από 30 ημέρες από τότε που ολοκλήρωσε τη συμμετοχή του σε κάποια άλλη μελέτη ερευνητικού ιατροτεχνολογικού προϊόντος ή φαρμάκου ή λαμβάνει άλλους ερευνητικούς παράγοντες.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Subject incidence of adverse events |
Επίπτωση ανεπιθύμητων συμβάντων στους ασθενείς. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Day 1, weeks 4, 12, 24, 36, 48, 52, 76 and 104 |
Ημέρα 1, Εβδομάδες 4, 12, 24, 36, 48, 52, 76 και 104. |
|
E.5.2 | Secondary end point(s) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | Yes |
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 | 3 |
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 | 7 |
E.8.9.1 | In the Member State concerned days | |
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 |