NCT02824432

Exploratory Study of the Effect of Omega-3-acid Ethyl Esters (TAK-085) on Vascular Endothelial Function in Patients With Hyperlipidemia by Flow Mediated Dilation

Exploratory Study of the Effect of Omega-3-acid Ethyl Esters on Vascular Endothelial Function in Patients With Hyperlipidemia by Flow Mediated Dilation

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 37 (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 omega-3-acid ethyl esters (TAK-085) on vascular endothelial function when administered for 8 weeks, as measured by FMD, in patients with hyperlipidemia.

Detailed description

This is a multicenter, collaborative, randomized, open-label study designed to explore the effects of administration of omega-3-acid ethyl esters (TAK-085) \[2 g (2 g PO QD) or 4 g (2 g PO BID) for 8 weeks\] on vascular endothelial function, as measured by flow-mediated dilation (FMD), in patients receiving a hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor and have concurrent hypertriglyceridemia. Considering the potential bias by factors that affect FMD between treatment groups, stratified allocation will be performed with fasting triglyceride (TG) level as a factor.

Conditions

• Hyperlipidemia

Interventions

Type	Name	Description
DRUG	TAK-085	TAK-085 capsules

Timeline

• Start date: 2016-08-04
• Primary completion: 2017-08-19
• Completion: 2017-08-19
• First posted: 2016-07-06
• Last updated: 2019-05-06
• Results posted: 2019-05-06

Locations

4 sites across 1 country: Japan