- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00959842
Effects of Lovaza on Lipoprotein Composition and Function in Mild Hypertriglyceridemia (ELLF)
September 23, 2021 updated by: William S. Harris, Sanford Research
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 Overview
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 Type
Interventional
Enrollment (Actual)
15
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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South Dakota
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Sioux Falls, South Dakota, United States, 57105
- Sanford Research/USD
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 79 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lovaza
Lovaza was given as the only agent; there was no comparator agent or arm
|
1 gram gel capsule 4 capsules per day for 8 weeks
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HDL 15-HEPE
Time Frame: 4 months
|
high density lipoprotein level of 15-HEPE
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Gregory C Shearer, PhD, Sanford Research/USD
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Actual)
February 1, 2010
Study Completion (Actual)
February 1, 2010
Study Registration Dates
First Submitted
August 14, 2009
First Submitted That Met QC Criteria
August 14, 2009
First Posted (Estimate)
August 17, 2009
Study Record Updates
Last Update Posted (Actual)
October 20, 2021
Last Update Submitted That Met QC Criteria
September 23, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LVZ 112860
- GSK - LVZ 112860 (Other Grant/Funding Number: GlaxoSmithKline)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Lovaza
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AstraZenecaCompletedSevere HypertriglyceridemiaUnited States, Canada
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University of VirginiaReliant PharmaceuticalsWithdrawn
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University of TennesseeUnknownParenteral Nutrition Associated Liver DiseaseUnited States
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St. Luke's-Roosevelt Hospital CenterGlaxoSmithKlineNo longer available
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University of UtahGlaxoSmithKlineWithdrawnEffects of Lovaza on High Density Lipoprotein (HDL) Composition and Function in HypertriglyceridemiaHypertriglyceridemiaUnited States
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University of Illinois at ChicagoTerminatedNonalcoholic Steatohepatitis (NASH) | Hepatic SteatosisUnited States
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Milton S. Hershey Medical CenterWithdrawn
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Brigham and Women's HospitalGlaxoSmithKlineUnknown
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Vanderbilt UniversityNational Cancer Institute (NCI)CompletedColorectal Adenomatous PolypsUnited States