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 |
Cantidades anormales 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 | 17.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020604 |
E.1.2 | Term | Hypercholesterolemia |
E.1.2 | System Organ Class | 100000004861 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10058110 |
E.1.2 | Term | Dyslipidemia |
E.1.2 | System Organ Class | 100000004861 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate change over time in executive function, as assessed by the Cambridge Neuropsychological Test Automated Battery (CANTAB) Spatial Working Memory (SWM) strategy index of executive function, in subjects receiving statin therapy in combination with evolocumab, compared with subjects receiving statin therapy in combination with placebo. |
Evaluar el cambio con el tiempo de la función ejecutiva, según la evaluación del índice de estrategia de la función ejecutiva en la prueba de la memoria de trabajo espacial (MTE) de la batería automatizada de pruebas neuropsicológicas de Cambridge (CANTAB), en sujetos que reciben tratamiento con estatinas en combinación con evolocumab, en comparación con los sujetos que reciben tratamiento con estatinas en combinación con placebo. |
|
E.2.2 | Secondary objectives of the trial |
To evaluate change over time in subjects receiving statin therapy in combination with evolocumab, compared with subjects receiving statin therapy in combination with placebo in the following: - Working memory, as assessed by the CANTAB Spatial Working Memory (SWM) test between-errors score - Memory function, as assessed by the CANTAB Paired Associates Learning (PAL) test - Psychomotor speed, as assessed by the CANTAB Reaction Time (RTI) test. |
Evaluar el cambio con el tiempo en sujetos que reciben tratamiento con estatinas en combinación con evolocumab, en comparación con los sujetos que reciben tratamiento con estatinas en combinación con placebo en lo siguiente: - La memoria de trabajo, según la evaluación de la puntuación entre errores en la prueba de memoria de trabajo espacial (MTE) de la CANTAB. - La función de la memoria, según la evaluación de la prueba de aprendizaje de pares asociados (PAL) de la CANTAB. - La velocidad psicomotora, según la evaluación de la prueba del tiempo de reacción (TR) de la CANTAB. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Signed informed consent for Study 20130385 2) Randomized into Study 20110118 (FOURIER) |
1) Consentimiento informado firmado para el estudio 20130385 2) Aleatorizado en el estudio 20110118 (FOURIER) |
|
E.4 | Principal exclusion criteria |
1) Current or known past diagnosis of dementia or mild cognitive impairment (MCI) 2) Any condition or situation, including other significant mental or neurological disorders that, in the investigator?s opinion, may confound the study results, or may interfere significantly with the subject?s participation in Study 20130385 or in Study 20110118 |
1) Diagnóstico actual o pasado conocido de demencia o deterioro cognitivo leve (DCL). 2) Cualquier trastorno o situación, incluidos otros trastornos mentales o neurológicos significativos que, en opinión del investigador, puedan confundir los resultados del estudio, o puedan interferir significativamente en la participación del sujeto en el estudio 20130385 o en el estudio 20110118. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
SWM strategy index of executive function. |
El índice de estrategia de la función ejecutiva en la MTE |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
From baseline assessment to end of study visit assessment |
Desde la evaluación basal hasta la evaluación final al fin del estudio |
|
E.5.2 | Secondary end point(s) |
- SWM between-errors score - PAL total errors adjusted - RTI median 5-choice reaction time. |
- La puntuación entre errores en la MTE. - Total de errores ajustados del PAL. - El tiempo de reacción (TR) mediano de 5 elecciones. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
From baseline assessment to end of study visit assessment |
Desde la evaluación basal hasta la evaluación final al fin del estudio |
|
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 | 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 | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 253 |
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 |
Australia |
Belgium |
Canada |
Czech Republic |
Denmark |
Estonia |
Finland |
France |
Germany |
Greece |
Hong Kong |
Hungary |
Italy |
Japan |
Latvia |
Lithuania |
Malaysia |
Netherlands |
New Zealand |
Norway |
Poland |
Portugal |
Russian Federation |
Singapore |
Slovakia |
South Africa |
Spain |
Sweden |
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
|
Study 20130385 will end concurrently with Study 20110118. Study 20110118 is event driven and will conclude when at least 1630 subjects have experienced an event adjudicated as qualifying for the first secondary endpoint (composite of cardiovascular death, myocardial infarction, or stroke). |
Estudio 20130385 terminará al mismo tiempo que el estudio 20110118. Estudio 20110118 está dirigido por los acontecimientos y terminará cuando al menos 1.630 sujetos hayan experimentado un evento adjudicado que cumple los requisitos de la primera variable secundaria (compuesta de muerte cardiovascular, infarto de miocardio o infarto cerebral). |
|
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 | 9 |
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 | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |