"Phospholipovit" vs Placebo in Patients With Combined Hyperlipidemia

• Status: Completed
• Trial end date: 2022-12-20
• Target enrollment: 0
• Participant gender: All

Summary

"Phospholipovit" vs placebo in patients with combined hyperlipidemia

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Biomedical Chemistry, Russia

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.