"Phospholipovit" vs Placebo in Patients With Combined Hyperlipidemia
Combined Hyperlipidemia
About this trial
This is an interventional treatment trial for Combined Hyperlipidemia focused on measuring Phospholipid nanoparticles, non-HDL-C level, TG level
Eligibility Criteria
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.
Sites / Locations
- Federal State Budgetary Institution "National Medical Research Centre Of Cardiology" of the Ministry of Health of the Russian Federation
- LLC "Nizhny Novgorod Medical clinic"
- LLC "Medical Center for Diagnostics and prevention plus"
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
"Phospholipovit"
Placebo
Powder for preparing a solution for oral administration. 500 mg orally 2 times a day, for 12 weeks
Powder for preparing a solution for oral administration. 500 mg orally 2 times a day, for 12 weeks