A multicentre, randomised, double-blind, controlled with placebo clinical trial with parallel groups, for the evaluation of the efficacy and safety of combined treatment with L-carnitine and simvastatin in the reduction of serum lipoprotein (a) or/and triglycerides in patients with mixed hyperlipidemia

INTERVENTION: Trade Name: Inestom Pharmaceutical Form: Oral solution INN or Proposed INN: L‐Carnitine Concentration unit: g gram(s) Concentration type: equal Concentration number: 1‐ Pharmaceutical form of the placebo: Oral solution Route of administration of the placebo: Oral use Trade Name: Antichol Pharmaceutical Form: Coated tablet INN or Proposed INN: Simvastatin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20‐ CONDITION: This study will evaluate the safety and efficacy of combined treatment with L‐ Carnitine and Simvastatin in reducing the Lipoprotein (a) and triglyceride level of patients with mixed hyperlipidemia. It can also include recently diagnosed patients wih diabetes mellitus type 2, who receive only dietary treatment. Lipoprotein (a) and hyperlipidemia are known risk factors for cardiovascular heart disease. ; MedDRA version: 8.1 Level: LLT Classification code 10027763 Term: Mixed hyperlipidemia PRIMARY OUTCOME: Main Objective: The main objective of this trial is to estimate the efficacy and safety of combined treatment with L‐ carnitine and simvastatin in reducing the serum lipoprotein (a) and tiglyceride levels in patients with mixed hyperlipidemia, after 12 weeks of treatment. Primary end point(s): Reduction of serum lipoprotein a or/ and serum triglycerides levels after a 12 week period of treatment with the study's drug combination (L‐carnitine and simvastatin). Assessment of drug safety and tolerance. Secondary Objective: To (voluntary) estimate the efficacy and safety of combined treatment with L‐ carnitine and simvastatin in reducing the serum lipoprotein (a) and triglyceride levels in patients with mixed hyperlipidemia, after 24 weeks of treatment.; The assesement of safety and tolerance of the drug combination during the full study duration.; INCLUSION CRITERIA: 1. Patients capable of reading and understanding the Informed Consent Form. 2. Patients who signed the Informed Consent Form. 3. Patients with mixed hyperlipidemia (LDL> 160mg/dL, TG> 200mg/dL and Lp(a)> 20mg/dL[> 0.71mmol/L]) or/and recently diagnosed patients with diabetes mellitus type 2 [during the last 6 months] according to the American Diabetes Association, who are receiving only dietary treatment. 4. Outpatient subjects of both genders, aged between 18 and 65 years old (margins included). 5. Patients willing and able to attend the study program, according to its time limitations Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range