"Phospholipovit" vs placebo in patients with combined hyperlipidemia
It is well known that atherosclerosis and its complications are the leading cause of morbidity and mortality in the world, and the high blood cholesterol is one of the leading risk factors for atherosclerosis. Among cholesterol-lowering agents, the most common are inhibitors of HMG-CoA reductase, so-called statins. Nevertheless, low attention is paid to the process responsible for cholesterol removing from the cells - the so-called "reverse cholesterol transport" (RCT). The major lipoproteins, involved in RCT, are high-density lipoproteins (HDL). The effectiveness of RCT is determined not only by the level of cholesterol in HDL, but also by the composition of HDL, in particular, by the content of phosphatidylcholine (PC) in HDL. Based on the original phospholipid composition, the Institute of Biomedical Chemistry developed the "Phospholipovit" - the aqueous medium of nanoemulsion of phospholipids with a particle size of 20-25 nm. The intestinal absorption of phospholipids nanoemulsion should contribute to the HDL enrichment by phospholipids, and, consequently, to the enhancement of RCT. A study of the safety and tolerability of the "Phospholipovit" in healthy patients has been completed. The "Phospholipovit" has demonstrated safety and tolerability. The main objective of this study is to evaluate the effectiveness and safety of "Phospholipovit", a powder for preparation of an oral solution, 500 mg compared with placebo in patients with combined hyperlipidemia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
500 mg orally 2 times a day, for 12 weeks
500 mg orally 2 times a day, for 12 weeks
Federal State Budgetary Institution "National Medical Research Centre Of Cardiology" of the Ministry of Health of the Russian Federation
Moscow, Russia
LLC "Nizhny Novgorod Medical clinic"
Nizhny Novgorod, Russia
LLC "Medical Center for Diagnostics and prevention plus"
Yaroslavl, Russia
Percentage change from baseline in non-HDL-C values
The efficacy is evaluated in terms of the percentage change from baseline in non-HDL-C values
Time frame: week 12
Dynamics of change of total cholesterol level compared with the baseline
The efficacy is evaluated in terms of the dynamics of change of total cholesterol level compared with the baseline
Time frame: week 12
Dynamics of change of LDL-C level compared with the baseline
The efficacy is evaluated in terms of the dynamics of change of LDL-C level compared with the baseline
Time frame: week 12
Dynamics of change of HDL-C level compared with the baseline
The efficacy is evaluated in terms of the dynamics of change of HDL-C level compared with the baseline
Time frame: week 12
Dynamics of change of TG level compared with the baseline
The efficacy is evaluated in terms of the dynamics of change of TG level compared with the baseline
Time frame: week 12
Dynamics of change of VLDL-C level compared with the baseline
The efficacy is evaluated in terms of the dynamics of change of VLDL-C level compared with the baseline
Time frame: week 12
Dynamics of change of Apo-A1 level compared with the baseline
The efficacy is evaluated in terms of the dynamics of change of Apo-A1 level compared with the baseline
Time frame: week 12
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Dynamics of change of Apo-B level compared with the baseline
The efficacy is evaluated in terms of the dynamics of change of Apo-B level compared with the baseline
Time frame: week 12
Dynamics of change of LP (a) level compared with the baseline
The efficacy is evaluated in terms of the dynamics of change of LP (a) level compared with the baseline
Time frame: week 12
Dynamics of change of atherogenic index compared with the baseline
The efficacy is evaluated in terms of the dynamics of change of atherogenic index compared with the baseline
Time frame: week 12
Dynamics of average hs-CRP level compared with the baseline
The efficacy is evaluated in terms of the dynamics of average hs-CRP level compared with the baseline
Time frame: week 12
Change in composition and particle size of fasting HDL-C, LDL-C and VLDL-C compared with the baseline
The efficacy is evaluated in terms of the change in composition and particle size of fasting HDL-C, LDL-C and VLDL-C compared with the baseline (limited sample of patients)
Time frame: week 12