This site uses cookies. By continuing to use this site, you are agreeing to our use of cookies. » Find out more

We may collect and process non-personal information about your visit to this website, such as noting some of the pages you visit and some of the searches you perform. Such anonymous information is used by us to help improve the contents of the site and to compile aggregate statistics about individuals using our site for internal market research purposes only. In doing this, we may install “cookies.”

 

Takeda Clinical Trials

« Found Trials

Official Title

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

Takeda Trial ID

TAK-085-4002

Trial Phase

Phase 4

Condition

Dyslipidemia


Compound

TAK-085, omega-3-acid ethyl esters 90, LOTRIGA


Recruitment Status

Completed

NCT Number

NCT02839902

Other Trial IDs

JapicCTI-163322, JapicCTI-R181144, U1111-1185-0054


Acronym

LOTUS

Trial Type

Interventional


Brief 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 ...

Read more


Trial Design

Intervention Model: Parallel Assignment


Primary outcome measures

  • Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Small Dense Low Density Lipoprotein (sdLDL) Fraction [Time Frame: Baseline, Week 4 and Week 8] [Designated as Safety Issue: No]
  • Percent Changes From Baseline in Triglycerides (TG) to Cholesterol Ratio in sdLDL Fraction [Time Frame: Baseline, Week 4, and Week 8] [Designated as Safety Issue: No]
  • Percent Change From Baseline in Mean Particle Sizes of Small Dense Low Density Lipoprotein-cholesterol (sdLDL-C) and Low Density Lipoprotein-cholesterol (LDL-C) Monitored by Major 4 Lipid Constituents [Time Frame: Baseline, Week 4, and Week 8] [Designated as Safety Issue: No]

Secondary outcome measures

  • Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Chylomicron (CM) Fraction [Time Frame: Baseline, Week 4 and Week 8] [Designated as Safety Issue: No]
  • Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Very Low-density Lipoprotein (VLDL) Fraction [Time Frame: Baseline, Week 4 and Week 8] [Designated as Safety Issue: No]
  • Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Low-density Lipoprotein (LDL) Fraction [Time Frame: Baseline, Week 4 and Week 8] [Designated as Safety Issue: No]

Read more


Trial arms/groups or cohorts

  • Experimental: Control Group
    • Stable HMG-CoA reductase inhibitor regimen at a consistent dose only.
    • Intervention: : Not treated with omega-3-acid ethyl esters

  • Experimental: TAK-085 4g
    • A dose of 2 g of omega-3-acid ethyl esters (TAK-085) capsule is orally administered immediately after meal twice a daily (totally 4g per a day) for 8 weeks, plus a stable HMG-CoA reductase inhibitor regimen (started ≥4 weeks prior to informed consent) at a consistent dose.
    • Intervention: drug: TAK-085

Recruitment Information