NCT02839902

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Hyperlipidemia

Interventions

Type	Name	Description
DRUG	TAK-085	Omega-3-acid ethyl esters (TAK-085) capsule
OTHER	Not treated with omega-3-acid ethyl esters	Not treated with omega-3-acid ethyl esters

Timeline

• Start date: 2016-12-27
• Primary completion: 2017-08-30
• Completion: 2017-08-30
• First posted: 2016-07-21
• Last updated: 2019-02-11
• Results posted: 2019-02-11

Locations

7 sites across 1 country: Japan