N/A
Completed N=3,084
Evaluation of the Safety and Efficacy of Long-term Use of Omega-3 Fatty Acid Ethyl Esters
Source: ClinicalTrials.gov NCT02153073 ↗Enrolled (actual)
3,084
Serious AEs
0.9%
Results posted
Jul 2019
Primary outcomePrimary: Number of Participants Who Had One or More Adverse Events (AE) and Serious Adverse Events (SAE) — 130; 26 Participants
Summary
The purpose of this study is to evaluate the safety and efficacy of long-term use of granular capsule formulation of omega-3 fatty acid ethyl esters (Lotriga Granular Capsules) in patients with hyperlipidemia in daily medical practice
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Had One or More Adverse Events (AE) and Serious Adverse Events (SAE) |
130; 26 | — |
| SECONDARY Percent Change From Baseline in Lipid Parameters - Triglycerides (TG) |
-20.54 | — |
| SECONDARY Percent Change From Baseline in Lipid Parameters - LDL Cholesterol (LDL-C) |
7.73 | — |
| SECONDARY Percent Change From Baseline in Lipid Parameters - VLDL Cholesterol (VLDL-C) |
-14.15 | — |
| SECONDARY Percent Change From Baseline in Lipid Parameters - Apo-B |
-7.21 | — |
| SECONDARY Percent Change From Baseline in Lipid Parameters - Apo-CIII |
-5.49 | — |
| SECONDARY Percent Change From Baseline in Lipid Parameters - Lipoprotein |
-2.98 | — |
| SECONDARY Percent Change From Baseline in Lipid Parameters -Remnant-Like Particles-Cholesterol (RLP-C) |
-22.42 | — |
| SECONDARY Percent Change From Baseline in Lipid Parameters - Total Cholesterol (TC) |
-4.26 | — |
| SECONDARY Percent Change From Baseline in Lipid Parameters - Non-HDL Cholesterol (Non-HDL-C) |
-1.42 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with hyperlipidemia
Exclusion Criteria
- Patients with hemorrhage (e.g., hemophilia, capillary fragility, gastrointestinal ulcer, urinary tract hemorrhage, hemoptysis, or vitreous hemorrhage)
- Patients with a history of hypersensitivity to ingredients in granular capsule formulation of omega-3 fatty acid ethyl esters
Data sourced from ClinicalTrials.gov (NCT02153073). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.