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Exploratory Study of the Effects of Omega-3-acid Ethyl Esters on the Lipid and Lipoprotein Profile in the Blood

2016-07-22 02:53:22 | BioPortfolio

Summary

The purpose of this study is to explore the effects of 8-week treatment with omega-3-acid ethyl esters on the lipid and lipoprotein profile in the blood in hyperlipidemic patients receiving a HMG-CoA reductase inhibitor by use of HPLC in comparison with the control group of patients not treated with omega-3-acid ethyl esters.

Description

This study was designed to explore the effects of omega-3-acid ethyl esters on the lipid and lipoprotein profile in the blood in hyperlipidemic patients receiving a hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor in comparison with the control group of patients not treated with omega-3-acid ethyl esters in an unblinded manner by use of high performance liquid chromatography (HPLC) using highly-sensitive gel filtration columns, which is a technique for analyzing lipoprotein.

Study participants who gave consent and were assessed as eligible in the eligibility assessment will be stratified by the factors of "fasting triacylglycerol (TG; <300 mg/dL or 300 mg/dL≤) and age (<65 years or 65 years≤) at the start of the screening period" and allocated to either the group treated with omega-3-acid ethyl esters or the group not treated with omega-3-acid ethyl esters (1:1 ratio).

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Conditions

Hyperlipidemia

Intervention

TAK-085, Not treated with omega-3-acid ethyl esters

Status

Not yet recruiting

Source

Takeda

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-07-22T02:53:22-0400

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Medical and Biotech [MESH] Definitions

Salts or esters of carbamic acid, H2NC(=O)OH, or of N-substituted carbamic acids: R2NC(=O)OR', (R' = hydrocarbyl or a cation). The esters are often called URETHANE or urethan, a usage that is strictly correct only for the ethyl esters. (From IUPAC [Internet]. International Union Of Pure And Applied Chemistry; c1995 [updated 2004 Jan 9; cited 2004 May 3]. Available from http://www.chem.qmul.ac.uk/iupac/class/oneN.html#35/).

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Phosphoric acid esters of inositol. They include mono- and polyphosphoric acid esters, with the exception of inositol hexaphosphate which is PHYTIC ACID.

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