Ignite Creation Date:
2024-05-06 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05742022
Status:
COMPLETED
Last Update Posted:
2023-02-23
First Post:
2023-02-01
Brief Title:
Phospholipovit vs Placebo in Patients With Combined Hyperlipidemia
Sponsor:
Institute of Biomedical Chemistry Russia
Organization:
Institute of Biomedical Chemistry Russia
Study Overview
Official Title:
A Randomized Double-blind Multicenter Placebo-controlled Clinical Trial of Safety and Efficacy of Phospholipovit in Patients With Combined Hyperlipidemia
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None