Trial Outcomes & Findings for Effects of Lovaza on Lipoprotein Composition and Function in Mild Hypertriglyceridemia (NCT NCT00959842)

NCT ID: NCT00959842

Last Updated: 2021-10-20

Results Overview

high density lipoprotein level of 15-HEPE

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 15 participants
• Primary outcome timeframe: 4 months
• Results posted on: 2021-10-20

Participant Flow

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.

No run in or wash out

Participant milestones

Measure	Lovaza Lovaza was given as the only agent; there was no comparator agent or arm Lovaza: 1 gram gel capsule 4 capsules per day for 8 weeks
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Lovaza on Lipoprotein Composition and Function in Mild Hypertriglyceridemia

Baseline characteristics by cohort

Measure	Lovaza n=15 Participants Lovaza was given as the only agent; there was no comparator agent or arm Lovaza: 1 gram gel capsule 4 capsules per day for 8 weeks
Age, Continuous	59 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants
lipids LDL-C	88 mg/dL n=5 Participants
lipids HDL-C	38 mg/dL n=5 Participants
lipids TG	237 mg/dL n=5 Participants

PRIMARY outcome

Timeframe: 4 months

Population: hypertriglyceridemic statin treated patients

high density lipoprotein level of 15-HEPE

Outcome measures

Measure	Lovaza n=15 Participants Lovaza was given as the only agent; there was no comparator agent or arm Lovaza: 1 gram gel capsule 4 capsules per day for 8 weeks
HDL 15-HEPE baseline	3.7 nmol/mmol phospholipid Interval 2.7 to 4.1
HDL 15-HEPE final	10.4 nmol/mmol phospholipid Interval 9.5 to 11.0

Adverse Events

Treatment Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Greg Shearer

Professor

Phone: 814-867-3040

Email: gcs13@psu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place