NCT05742022

"Phospholipovit" vs Placebo in Patients With Combined Hyperlipidemia

A Randomized, Double-blind, Multicenter, Placebo-controlled Clinical Trial of Safety and Efficacy of "Phospholipovit" in Patients With Combined Hyperlipidemia

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Institute of Biomedical Chemistry, Russia · Academic / Other
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

"Phospholipovit" vs placebo in patients with combined hyperlipidemia

Detailed description

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.

Conditions

• Combined Hyperlipidemia

Interventions

Type	Name	Description
DRUG	"Phospholipovit"	500 mg orally 2 times a day, for 12 weeks
DRUG	Placebo	500 mg orally 2 times a day, for 12 weeks

Timeline

• Start date: 2016-01-01
• Primary completion: 2018-06-20
• Completion: 2022-12-20
• First posted: 2023-02-23
• Last updated: 2023-02-23

Locations

3 sites across 1 country: Russia