ELLF: Effects of Lovaza on Lipoprotein Composition and Function in Mild Hypertriglyceridemia

• Sponsor: Sanford Research (Other)
• Overall Status: Completed
• CT.gov ID: NCT00959842
• Collaborator: GlaxoSmithKline (Industry)
• Enrollment: 15
• Location: 1
• Arm: 1
• Duration (Months): 5
• Patients Per Site Per Month: 3

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Hypertriglyceridemia	Drug: Lovaza	Phase 1/Phase 2

Detailed Description

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effects of Lovaza on Lipoprotein Composition and Function in Mild Hypertriglyceridemia
• Study Start Date: Sep 1, 2009
• Actual Primary Completion Date: Feb 1, 2010
• Actual Study Completion Date: Feb 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lovaza 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; Other Names: Omega-3 Fatty Acid fish oil Omacor

Outcome Measures

Primary Outcome Measures

1. HDL 15-HEPE [4 months]

   high density lipoprotein level of 15-HEPE

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 79 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 18-79 years

• Stable does of statins ≥ 8 weeks prior to screening

• Good health by medical history, physical exam, electrocardiogram, laboratory test (e.g., serum chem., urinalysis)

• Mean fasting serum triglyceride of two most recent tests in medical record ≥ 200 and < 500 mg/dL

• Mean LDL-cholesterol of two most recent tests in medical record ≤ 1.1 × NCEP ATP III goal

Exclusion Criteria:

• Medications, vitamin pills, nutritional supplements or herbal preparations deemed exclusionary per primary investigator for possible interference

• Poorly controlled diabetes mellitus (e.g. [HbA1c] > 8.0%)

• History of a cardiovascular event

• Past revascularization procedure

• Past aortic aneurysm or an aortic dissection < 6 months prior to screening

• History of pancreatitis

• Sensitivity to any statin OR to omega-3 fatty acids or fish products

• Poorly controlled hypertension (i.e.: >=160 systolic (resting) and/or >=100 diastolic (resting)) at 2 consecutive visits

• Serum Creatinine ≥ 2.0 mg/dL

• Serum transaminase > 1.5 × upper limit of normal (ULN); including aspartate aminotransferase [AST] or alanine aminotransferase [ALT]; 31 U/L for AST, 45 U/L for ALT

• Creatine Kinase (CK) > 3.0 × ULN

• Taking other triglyceride lowering drugs (e.g., niacin, fibrates) or fish oil supplements providing more than 500 mg of EPA+DHA per day

• Contraindications for Lovaza per product insert

• Women who are pregnant or nursing

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sanford Research/USD	Sioux Falls	South Dakota	United States	57105

Sponsors and Collaborators

• Sanford Research
• GlaxoSmithKline

Investigators

• Principal Investigator: Gregory C Shearer, PhD, Sanford Research/USD

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: William S. Harris, Adjunct Senior Scientist, Sanford Research
• ClinicalTrials.gov Identifier: NCT00959842
• Other Study ID Numbers: LVZ 112860; GSK - LVZ 112860
• First Posted: Aug 17, 2009
• Last Update Posted: Oct 20, 2021
• Last Verified: Sep 1, 2021

• Keywords provided by William S. Harris, Adjunct Senior Scientist, Sanford Research: hypertriglyceridemia; Omega-3 Fatty Acids; Lipoprotein; Statin; Lovaza
• Additional relevant MeSH terms: Hypertriglyceridemia

Study Results

Participant Flow

Recruitment Details	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.
Pre-assignment Detail	No run in or wash out

Arm/Group Title	Lovaza
Arm/Group Description	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
Period Title: Overall Study
STARTED	15
COMPLETED	15
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Lovaza
Arm/Group Description	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 Participants	15
Age (years) [Mean (Inter-Quartile Range) ]
Mean (Inter-Quartile Range) [years]	59
Sex: Female, Male (Count of Participants)
Female	5 33.3%
Male	10 66.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	15 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	15 100%
lipids (mg/dL) [Median (Inter-Quartile Range) ]
LDL-C	88
HDL-C	38
TG	237

Outcome Measures

1. Primary Outcome

Title	HDL 15-HEPE
Description	high density lipoprotein level of 15-HEPE
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

hypertriglyceridemic statin treated patients

Arm/Group Title	Lovaza
Arm/Group Description	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
Measure Participants	15
baseline	3.7
final	10.4

Adverse Events

Arm/Group Title	Treatment Group
Arm/Group Description	all patients were treated with n3
All Cause Mortality
	Treatment Group
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Treatment Group
	Affected / at Risk (%)	# Events
Total	0/15 (0%)
Other (Not Including Serious) Adverse Events
	Treatment Group
	Affected / at Risk (%)	# Events
Total	0/15 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.