A Phase 1/2 interventional study of Lovaza in Hypertriglyceridemia, sponsored by Sanford Research. Completed at 1 site in United States. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2021-10-20.
Sponsored by Sanford Research · Phase 1/2, Interventional, and Treatment
This study will build upon a previous finding that showed a triglyceride lowering effect of prescription omega-3 in combined therapy with statins. The proposed study will use a simple change from baseline design on 15 subjects who are hypertriglyceridemic on stable statin therapy. The protocol involves 3 study visits; each involve drawing a blood sample: day 1 - screening (blood draw for qualification and safety); day 7 - before taking prescription omega-3 fatty acids (Lovaza, 4 capsules/d; GlaxoSmithKline), day 63 -after taking prescription omega-3 fatty acids (Lovaza, 4 capsules/d; GlaxoSmithKline). The proposed study will include up to 15 subjects and will utilize several different measures of lipoprotein structure and function. The investigators will measure functional parameters such as the binding affinity of lipoproteins before and after treatment with omega-3 fatty acids. The investigators will also measure fatty acid, oxylipin and apolipoprotein content of plasma, very-low-density lipoprotein (VLDL), low-density lipoprotein (LDL) and high-density lipoprotein (HDL).
This study will build upon a previous finding that showed a triglyceride lowering effect of prescription omega-3 in combined therapy with statins. The proposed study will use a simple change from baseline design on 15 subjects who are hypertriglyceridemic on stable statin therapy. The protocol involves 3 study visits; each involve drawing a blood sample: day 1 - screening (blood draw for qualification and safety); day 7 - before taking prescription omega-3 fatty acids (Lovaza, 4 capsules/d; GlaxoSmithKline), day 63 -after taking prescription omega-3 fatty acids (Lovaza, 4 capsules/d; GlaxoSmithKline). The proposed study will include up to 15 subjects and will utilize several different measures of lipoprotein structure and function. The investigators will measure functional parameters such as the binding affinity of lipoproteins before and after treatment with omega-3 fatty acids. The investigators will also measure fatty acid, oxylipin and apolipoprotein content of plasma, very-low-density lipoprotein (VLDL), low-density lipoprotein (LDL) and high-density lipoprotein (HDL).
296 studies on the registry are indexed under Hypertriglyceridemia; 39 are open to participants now.
This study's enrollment of 15 is below the median of 66 across 259 interventional studies indexed under Hypertriglyceridemia.
Browse Hypertriglyceridemia studies →Sanford Research is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Lovaza was given as the only agent; there was no comparator agent or arm
Drug: Lovaza
1 gram gel capsule 4 capsules per day for 8 weeks
Also known as: Omega-3 Fatty Acid, fish oil, Omacor
HDL 15-HEPE
high density lipoprotein level of 15-HEPE
Time frame: 4 months
Patients on statins with persistent hypertriglyceridemia were identified by EMR search of hospital records. Letters were sent to eligible and those responding were screened and if qualifying, enrolled.
| Milestone | Lovaza |
|---|---|
| Started | 15 |
| Completed | 15 |
| Not completed | 0 |
high density lipoprotein level of 15-HEPE
| nmol/mmol phospholipid | Lovaza |
|---|---|
| baseline | 3.7 (2.7 to 4.1) |
| final | 10.4 (9.5 to 11) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment Group | — | 0/15 (0%) | 0/15 (0%) |
| Age, Continuous(years) | Lovaza |
|---|---|
| Mean | 59 (46 to 68) |
| Sex: Female, Male(Participants) | Lovaza |
|---|---|
| Female | 5 |
| Male | 10 |
| Race (NIH/OMB)(Participants) | Lovaza |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 15 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Lovaza |
|---|---|
| United States | 15 |
| lipids(mg/dL) | Lovaza |
|---|---|
| LDL-C | 88 (78 to 99) |
| HDL-C | 38 (33 to 42) |
| TG | 237 (200 to 270) |
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Sanford Research