E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Primary hyperlipidemia and mixed dyslipidemia |
Hiperlipidemia primaria y dislipidemia mixta |
|
E.1.1.1 | Medical condition in easily understood language |
High concentrations of lipids in the blood |
Concentración alta de lípidos en la sangre |
|
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 | 16.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10058108 |
E.1.2 | Term | Dyslipidaemia |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10016205 |
E.1.2 | Term | Familial hyperlipidaemia |
E.1.2 | System Organ Class | 100000004850 |
|
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 AMG 145 |
Describir la seguridad y la tolerabilidad de la administración a largo plazo de AMG 145 |
|
E.2.2 | Secondary objectives of the trial |
To characterize the long-term administration of AMG 145 as assessed by low density lipoprotein cholesterol (LDL-C) in subjects with primary hyperlipidaemia and subjects with mixed dyslipidaemia |
Describir la eficacia de la administración a largo plazo de AMG 145 evaluada mediante el colesterol ligado a lipoproteínas de baja densidad (C-LDL) en sujetos con hiperlipidemia primaria y sujetos con dislipidemia mixta. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects will be eligible for the study if they complete a qualifying AMG 145 parent study protocol while still on assigned study medication. |
Los sujetos serán elegibles para el estudio si completan un protocolo de un estudio padre de AMG 145 que cumple los criterios mientras aún reciben la medicación del estudio asignada. |
|
E.4 | Principal exclusion criteria |
Subjects will be ineligible for the study if they fulfill any of the following criteria: - Discontinued assigned study drug during the qualifying study for any reason including an adverse event or serious adverse event - Female subject is not willing to use at least one highly effective method of birth control during treatment and for an additional 15 weeks after the end of treatment unless subject is sterilized or postmenopausal; - menopause is defined as 12 months of spontaneous and continuous amenorrhea in a female ? 55 years old or 12 months of spontaneous and continuous amenorrhea with a follicle-stimulating hormone level > 40 IU/L (or according to the definition of "postmenopausal range" for the laboratory involved) in a female < 55 years old unless the subject has undergone bilateral oophorectomy. - Highly effective methods of birth control include abstinence, birth control pills, shots, implants, or patches, intrauterine devices (IUDs), sexual activity with a male partner who has had a vasectomy, condom or occlusive cap (diaphragm or cervical/vault caps) used with spermicide. - Subject is pregnant or breast feeding, or might become pregnant during treatment and/ or within 15 weeks after the end of treatment - Unreliability as a study participant based on the investigator's (or designee?s) knowledge of the subject (eg, inability or unwillingness to adhere to the protocol) - Disorder that would interfere with understanding and giving informed consent or compliance with protocol requirements - Have an unstable medical condition, in the judgment of the investigator. - Subject?s medical condition requires lipid measurement and/or adjustment of background lipid-regulating therapy during the first 12 weeks of study participation - Known sensitivity to any of the products to be administered during dosing - Currently enrolled in another investigational device or drug study (excluding AMG 145 parent study), or less than 30 days since ending another investigational device or drug study(s),or receiving other investigational agent(s) |
Los sujetos no serán elegibles para el estudio si cumplen cualquiera de los criterios siguientes: - Interrupción del fármaco del estudio asignado durante el estudio que cumple los requisitos por cualquier motivo, incluido un acontecimiento adverso o un acontecimiento adverso grave. - Mujer que no está dispuesta a utilizar al menos un método anticonceptivo altamente eficaz durante el tratamiento y durante las 15 semanas posteriores al final del tratamiento, salvo que sea posmenopáusica o estéril. .La menopausia se define como 12 meses seguidos de amenorrea espontánea en una mujer ? 55 años o 12 meses seguidos de amenorrea espontánea con un nivel de hormona folículoestimulante > 40 UI/L (o según la definición de "intervalo posmenopáusico" del laboratorio en cuestión) en una mujer < 55 años a menos que haya sido sometida a una ovariectomía bilateral?. .Los métodos anticonceptivos altamente eficaces incluyen abstinencia, píldoras anticonceptivas, inyecciones, implantes o parches, dispositivos intrauterinos (DIU), actividad sexual con un hombre que se haya sometido a una vasectomía, preservativos o dispositivos oclusivos (diafragma o capuchón cervical/en bóveda) utilizados con espermicida. - Mujer embarazada o en período de lactancia, o que planee quedarse embarazada durante el tratamiento y/o en las 15 semanas posteriores al fin del tratamiento. - Falta de fiabilidad como participante del estudio según los conocimientos del investigador (o persona designada) sobre el sujeto (p. ej., incapacidad o falta de voluntad de seguir el protocolo). - Trastorno que pueda interferir a la hora de que el sujeto comprenda y dé el consentimiento informado o en el cumplimiento de los requisitos del protocolo. - Presenta un cuadro médico inestable según el criterio del investigador. - El trastorno médico del sujeto requiere la determinación de lípidos y el ajuste de la terapia hipolipemiante de base durante las primeras 12 semanas de la participación en el estudio. - Sensibilidad conocida a alguno de los productos que se administrarán durante la dosificación. - Incluido actualmente en otro estudio de investigación de un fármaco o dispositivo (excepto el estudio padre de AMG 145), o han pasado menos de 30 días desde el fin de otro estudio de investigación de un fármaco o dispositivo, o recibe otro/s producto/s en investigación. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Subject incidence of adverse events |
Incidencia de acontecimientos adversos en los sujetos |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
The timepoints vary depending on whether the subject is on the QM or Q2W regimen and has prior experience of self-injection. The following are all the potential timepoints but please refer to the protocol for further details: Day 1, weeks 2, 4, 8, 12, 24, 44, 46, 48, 50, 52, 56, at every quarterly visit, weeks 100, 102, 104, 108 or early termination. |
El momento de evaluación puede variar dependiendo de si el sujeto está en régimen de QM o Q2W si y tiene experiencia previa con la autoinyección. A continuación están listados todos los momentos potenciales de evaluación (consultar protocolo para más información): Día 1, semanas 2, 4, 8, 12, 24, 44, 46, 48, 50, 52, 56, en cada visita trimestral, semanas 100, 102, 104, 108 o finalización prematura. |
|
E.5.2 | Secondary end point(s) |
? Percent change from baseline in LDL-C at week 48 and week 104 ? Change from baseline in LDL-C at week 48 and week 104 |
? Cambio porcentual en el C-LDL entre el valor basal y la semana 48 y la semana 104 ? Cambio en el C-LDL entre el valor basal y la semana 48 y la semana 104 |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Baseline (day 1) and weeks 48 and 104 |
Baseline (día 1) y semanas 48 and 104 |
|
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 | 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 | Yes |
E.6.13.1 | Other scope of the trial description |
Tolerability |
Tolerabilidad |
|
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Terapia hipolipemiante de base |
Background lipid lowering therapy |
|
E.8.2.4 | Number of treatment arms in the trial | 3 |
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 | 14 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 286 |
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 |
Austria |
Belgium |
Brazil |
Canada |
Czech Republic |
Denmark |
France |
Germany |
Hong Kong |
Hungary |
Italy |
Japan |
Korea, Republic of |
Mexico |
Netherlands |
New Zealand |
Norway |
Poland |
Russian Federation |
South Africa |
Spain |
Sweden |
Switzerland |
Taiwan |
Turkey |
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
|
LVLS |
Última visita último paciente |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |