E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Tratamiento de los pacientes con hiperlipemia, especialmente cuando ésta combina hipertrigliceridemia, hipercolesterolemia y HDL-c bajo. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020661 |
E.1.2 | Term | Hiperlipemia |
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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 |
Evaluar el efecto reductor absoluto y relativo de la Lp(a) de 1 g / 20 mg y de 2 g / 40 mg por día de niacina/laropiprant en sujetos con cifras normales de Lp (a) (menor de 30 mg/dl), con cifrras elevadas (30-60 mg/dl) y muy elevadas (menor de 60 mg/dl) |
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E.2.2 | Secondary objectives of the trial |
Evaluar el efecto reductor absoluto y relativo de la Lp(a) de 1 g /20 mg y de 2 g / 40 mg por día de niacina/laropirant en función del número de copias de kringle IV-2 en el gen de apo(a) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Edad >18 y <65 años 2. Cifras de LDLc entre 70 y 190 mg/dl. 3. Cifras de triglicéridos < 500 mg/dl. 4. Disponibilidad de al menos 2 determinaciones de Lp(a) previas al comienzo del estudio sin diferencias > 20 % o >20 mg/dl. 5. Ausencia de fármacos hipolipemiantes o dosis estables en los últimos 3 meses. |
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E.4 | Principal exclusion criteria |
1. Enfermedad hepática o enzimas hepáticas > 2 veces superiores a los valores de referencia. 2. Valores de creatinina > 2 mg/dl. 3. Úlcera péptica activa. 4. Episodio de gota en el último año. 5. Diabetes mellitus no controlada (HbA1c > 8%). 6. Participación en otro ensayo clínico en los 3 meses previos al comienzo del estudio. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Variable principal: Reducción absoluta y relativa en la concentración de Lp(a) con 1g/20mg y de 2g/40mg por día de niacina/laropiprant en sujetos con cifras normales de Lp(a) (<30 mg/dl), con cifras elevadas (30-60 mg/dl) y muy elevadas (>60mg/dl). Variable Secundaria: Reducción absoluta y relativa de Lp(a) con 1 g/20 mg y de 2 g/40 mg por día de niacina/laropiprant en función del número de copias de kringle IV-2 en el gen de apo(a) |
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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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | No |
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 |
Se incluirán sujetos con valores normales de Lp(a) como grupo control por lo que no es necesario un |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
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
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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 | 4 |
E.8.9.1 | In the Member State concerned days | 0 |