"Phospholipovit" vs Placebo in Patients With Combined Hyperlipidemia

"Phospholipovit" vs placebo in patients with combined hyperlipidemia

Inclusion Criteria:Availability of signed and dated informed consent of the patient to participate in the study;Patients with moderate combined hyperlipidemia, defined as:Total cholesterol level 3 - 7 mmol/l, LDL-C 2.5 - 5 mmol/l, TG 1.7 - 4.5 mmol/l, and HDL-C < 1 mmol/l during screening for men and < 1.2 mmol/l for women;Patient consent to use reliable contraceptive methods throughout the study;The patient's ability to adequately cooperation.Exclusion Criteria:TG > 4.5 mmol/l;Total cholesterol >7 mmol/l;LDL cholesterol >5 mmol/l;Age less than 30 or older than 75;Diseases or metabolic disorders that can cause an increase in LDL-C, total cholesterol and TG (secondary dyslipidemia);Patients receiving high doses of statin drugs (rosuvastatin ≥40 mg, atorvastatin ≥80 mg);Any acute or exacerbation of chronic infectious diseases;Type 1 Diabetes mellitus;Glomerular filtration rate less than 30 ml/min/1.73 m2;Patients who have undergone acute conditions (infections, injuries, operations) in the period less than 2 months before the start of the study;Patients with severe dysfunction of the liver and/or kidneys, and/or other vital organs, accompanied by decompensation of their functions; diseases of the central nervous system, with severe impairment of cognitive and mnestic functions;Persistent increase in liver enzymes activity (transaminases) of unclear etiology or increased liver enzymes activity by 2 or more times from the upper limit of the norm;Alcohol abuse more than 5 units of alcohol per week (1 unit alcohol is equivalent to 0.325 liters beer, 130 ml wine, 30 ml alcohol);Drug use;A history of a positive HIV test result;Positive test result for hepatitis B and C, syphilis;A history of hypothyroidism or thyroid-stimulating hormone levels (TSH) exceeding > 1X upper limit of normal (ULN) during screening;History of oncological disease during the last 5 years;Patients diagnosed with porphyria;Patients diagnosed with myopathy;Clinically significant abnormal blood test results general urinalysis at screening;Hypersensitivity to phospholipids or any components of investigational drug;Indications for drug therapy a list of therapies prohibited during the study;Any other diseases or conditions that, in the opinion of the investigator, may distort the results of the study and limit the patient's participation in the study;Pregnancy and lactation;Patient participation in another clinical trial or use of any investigational drug during 1 month prior to inclusion in the study;Not using contraception for patients of reproductive age.