Exploratory Study of the Effects of Omega-3-acid Ethyl Esters on the Lipid and Lipoprotein Profile in the Blood
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.
Timeline
- Start
- 2016-12-27
- Primary completion
- 2017-08-30
- Completion
- 2017-08-30
Outcome
Mixed primary results
registry analysis (other test); TAK-085 4 g vs Control Group; p = 0.0004; Least square (LS) mean difference -17.147 (95% CI -26.344 to -7.950); ANCOVA NCT02839902 ↗
registry analysis (other test); TAK-085 4 g vs Control Group; p = 0.1141; Least square (LS) mean difference -9.774 (95% CI -21.986 to 2.439); ANCOVA NCT02839902 ↗
registry analysis (other test); TAK-085 4 g vs Control Group; p = 0.1826; Least square (LS) mean difference 9.499 (95% CI -4.623 to 23.622); ANCOVA NCT02839902 ↗
registry analysis (other test); TAK-085 4 g vs Control Group; p = 0.0040; Least square (LS) mean difference 1.066 (95% CI 0.356 to 1.776); ANCOVA NCT02839902 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lovaza | Other / unclassified | 2 g | Oral |