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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/).

Methyl, propyl, butyl, and ethyl esters of p-hydroxybenzoic acid. They have been approved by the FDA as antimicrobial agents for foods and pharmaceuticals. (From Hawley's Condensed Chemical Dictionary, 11th ed, p872)

FATTY ACIDS which have the first unsaturated bond in the sixth position from the omega carbon. A typical American diet tends to contain substantially more omega-6 than OMEGA-3 FATTY ACIDS.

Salts or esters of acetic acid in which the terminal hydrogen atom is replaced by a metal, for instance copper acetate Cu(CH3COO)2, or where substitution is by a radical, for instance ethyl acetate CH3COOC2H5. (From Hawley's Condensed Chemical Dictionary, 12th ed)

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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