At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 53 enrolled
Drug / intervention
TAK-085 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Exploratory Study of the Effects of Omega-3-acid Ethyl Esters on the Lipid and Lipoprotein Profile in the Blood
In Brief
A Phase 4 clinical trial evaluating TAK-085 and Not treated with omega-3-acid ethyl esters for Hyperlipidemia. Completed, enrolled 53 participants across 7 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperlipidemia
CountriesJapan
Collaborators--
Timeline
Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedJul 2016
Enrollment StartDec 2016
Primary CompletionAug 2017
TodayJul 2026
First PostedJul 21, 2016
Enrollment StartDec 27, 2016
Primary CompletionAug 30, 2017
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 9.9 years ago
Interventions
TAK-085drug
Omega-3-acid ethyl esters (TAK-085) capsule
Not treated with omega-3-acid ethyl estersother
Not treated with omega-3-acid ethyl esters