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 |
High blood cholesterol level |
Livelli alti di colesterolo 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 | 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 |
|
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 evaluate the long-term safety and tolerability of SAR236553(REGN727) in high cardiovascular risk patients with hypercholesterolemia not adequately controlled with their current lipid modifying therapy (LMT). |
Valutare la sicurezza e la tollerabilità a lungo termine di SAR236553 nei pazienti ad alto rischio di malattia cardiovascolare con ipercolesterolemia non adeguatamente controllata con la terapia lipido-modificante (LMT). |
|
E.2.2 | Secondary objectives of the trial |
To evaluate the effect of SAR236553 (REGN727) on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison with placebo. - To evaluate the efficacy of SAR236553 (REGN727) on LDL-C levels at other time points |
-Valutare l'effetto di SAR236553 sui livelli del colesterolo trasportato dalle lipoproteine a bassa densità (colesterolo LDL-C) dopo 24 settimane di trattamento, rispetto al placebo. -Valutare l'efficacia di SAR236553 sui livelli del colesterolo LDL-C in altri momenti predefiniti. |
|
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 |
OTHER SUBSTUDIES:
- TITLE: Opthamological Sub-study
version 1 - 29.11.2011
- OBJECTIVES: to assess the clinical ophthalmic safety of SAR236553 in high cardiovascular risk patients with
hypercholesterolemia
|
ALTRI SOTTOSTUDI:
- TITOLO: Sottostudio Oftalmologico, versione 1 del 29.11.2011
- OBB: Valutare la sicurezza clinica a livello oculare di SAR236553 in pazienti ad alto rischio cardiovascolare con ipercolesteromia
|
|
E.3 | Principal inclusion criteria |
Either A or B below and not adequately controlled with a maximally tolerated stable daily dose of statin for at least 4 weeks prior to the screening visit with or without other lipid modifying therapy (LMT). A) Patients with heterozygous familial hypercholesterolemia (heFH) with or without established coronary heart disease (CHD) or CHD risk equivalents OR B) Patients with hypercholesterolemia together with established CHD or CHD risk equivalents. |
A o B (vedasi sotto) non adeguatamente controllate da una dose stabile di statina* al massimo della tollerabilità giornaliera assunta per almeno 4 settimane prima della visita di screening (settimana -2) con o senza terapia lipido-modificante (LMT). A) Pazienti con ipercolesterolemia familiare eterozigote (heFH) con o senza coronaropatia (CHD) conclamata o equivalenti di rischio di CHD OPPURE B) Pazienti con ipercolesterolemia e CHD conclamata o equivalenti di rischio di CHD. |
|
E.4 | Principal exclusion criteria |
• LDL-C <100 mg/dL (< 2.59 mmol/L) at the screening visit • Not on a stable dose of LMT (including statin) for at least 4 weeks and/or fenofibrate for at least 6 weeks, as applicable, prior to the screening visit or from screening to randomization. • Currently taking a statin that is not simvastatin, atorvastatin, or rosuvastatin taken daily at a registered dose. • Fasting serum TG > 400 mg/dL (>4.52 mmol/L) at the screening visit |
•LDL-C <100 mg/dL (<2.59 mmol/L) alla visita di screening. •Una dose non stabile di LMT (incluse statine) per almeno 4 settimane e/o fenofibrato per almeno 6 settimane, se pertinente, prima della visita di screening o dallo screening alla randomizzazione. •Assunzione in corso di una statina diversa da simvastatina, atorvastatina o rosuvastatina con assunzione giornaliera alla dose registrata. •TG sierici a digiuno >400 mg/dL (>4.52 mmol/L) alla visita di screening |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Assessment of safety parameters (adverse events [including adjudicated cardiovascular events, laboratory data, vital signs, and ECG |
Parametri di sicurezza (eventi avversi [inclusi eventi cardiovascolari aggiudicati], dati di laboratorio, segni vitali ed ECG) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Up to 20 months |
Fino a 20 mesi |
|
E.5.2 | Secondary end point(s) |
Percent change in calculated low density lipoprotein cholesterol (LDL-C) |
-Variazione percentuale del colesterolo calcolato LDL-C |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
From baseline to week 24 |
dal basale alla settimana 24 |
|
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 | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 118 |
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 |
Canada |
Chile |
Colombia |
Guatemala |
Israel |
Mexico |
Peru |
Russian Federation |
South Africa |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 33 |
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 | 33 |
E.8.9.2 | In all countries concerned by the trial days | 0 |