HypertriglyceridemiaPhase 4NCT01180764
Effects of Lovaza on High Density Lipoprotein (HDL) Composition and Function in Hypertriglyceridemia
A Phase 4 study testing Lovaza (Omega-3 acid ethyl esters) in people with Hypertriglyceridemia, run by University of Utah at 1 site in United States.
Trial summary
Study hypothesis: Lovaza (purified prescription fish oil) is likely to help HDL (the "good cholesterol") work better. Study summary: We are testing effects of Lovaza versus placebo, on various aspects of HDL and other lipoproteins, in patients with high triglyceride levels. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Hypertriglyceridemia
- What is being tested?
- Lovaza (Omega-3 acid ethyl esters)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Oct 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fasting TG 500-2000 mg/dL (off of TG-lowering medications-see below)
- Age 35-75 years
Who cannot join
- Use of Lovaza (2g/d or more) or high-dose dietary supplement omega-3 oil (4g/d or more) in the past 2 months
- Use of lipid therapy (statin, ezetimibe, fibrate, BAS, or niacin at therapeutic dose, 1g/d or higher) in the past 3 weeks (washout of prior therapy permitted)
- Anticipated need to change type or dose of BP medicine (all types allowed), of lipid-active diabetes medication (thiazolidinedione), of oral estrogen (BCP or HRT), or glucocorticoid during the study (16 + 2 weeks = 18 weeks total)
- Excess ethanol consumption (regular intake >4 drinks/d, or binges of >8 drinks at once for men, half these levels for women)
- Poorly controlled diabetes mellitus (A1c >9%)
- History of acute or chronic pancreatitis
Show all 15Show fewer
- Use of exenatide (Byetta) or sitagliptin (Januvia), medications believed to increase the risk of acute pancreatitis
- History of significant unexplained or uncontrolled bleeding or bruising
- Poorly controlled blood pressure (>140/90mmHg, with or without treatment)
- Poorly controlled thyroid disease (TSH outside of normal range)
- Hepatic disease (ALT > 2.5x ULN, Dx of hepatitis or cirrhosis)
- Any contraindication or prior adverse reaction to Lovaza
- Active cancer (except basal cell or squamous cell skin cancer)
- Pregnancy, plan/desire to become pregnant, breast feeding
- Inability or unwillingness to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Lovaza Monotherapy vs. Placebo on Composition and Function of HDL and Other Lipoproteins, and on Other Lipid-Related Parameters
Study hypothesis: Lovaza (purified prescription fish oil) is likely to help HDL (the "good cholesterol") work better.
Study summary: We are testing effects of Lovaza versus placebo, on various aspects of HDL and other lipoproteins, in patients with high triglyceride levels.
Study funding: This study is being funded by an investigator-initiated research grant from Glaxo Smith Kline.
- Conditions
- Hypertriglyceridemia
- Being tested
- Lovaza (Omega-3 acid ethyl esters), Placebo
- Keywords
- hypertriglyceridemia, omega-3 acid ethyl esters, high-density lipoproteins, fish oil
- Medical subject headings
- Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lovaza (Omega-3 acid ethyl esters)Drug
Also called Lovaza
1g capsules, 4 capsules po daily
PlaceboDrug
Placebo matching active lovaza, 1 g capsules, 4 capsules po daily
| Study group | Role | What they receive |
|---|---|---|
| Lovaza | Experimental | Lovaza 4g po qd Receives: Drug: Lovaza (Omega-3 acid ethyl esters) |
| Placebo | Placebo comparator | Matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
HDL Composition
HDL composition (protein and lipid) by size (gel filtration column)
Measured: 12 weeks
Secondary outcomes (2)
HDL cholesterol composition by density subfraction
HDL composition by density gradient ultracentrifugation
Measured: 12 weeks
Safety
Transaminases and glucose levels
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionAug 2012 (estimated)
- Study completionOct 2012 (estimated)
Why it stopped: Withdrawn for administrative reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertriglyceridemiaStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Investigators
- Eliot A Brinton, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01180764
- Sponsor's protocol ID
- 00040562
- Status last verified
- Jul 2011
- First submitted
- 17 May 2010
- Last updated
- 8 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lovaza Monotherapy vs. Placebo on Composition and Function of HDL and Other Lipoproteins, and on Other Lipid-Related Parameters
- ClinicalTrials.gov ID
- NCT01180764
- Acronym / sponsor ID
- 00040562
- Conditions
- Hypertriglyceridemia
- Keywords
- hypertriglyceridemia, omega-3 acid ethyl esters, high-density lipoproteins, fish oil
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn for administrative reasons.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Aug 2010
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 12 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study hypothesis: Lovaza (purified prescription fish oil) is likely to help HDL (the "good cholesterol") work better.
Study summary: We are testing effects of Lovaza versus placebo, on various aspects of HDL and other lipoproteins, in patients with high triglyceride levels.
Study funding: This study is being funded by an investigator-initiated research grant from Glaxo Smith Kline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lovaza | Experimental | Drug: Lovaza (Omega-3 acid ethyl esters)Lovaza 4g po qd |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Fasting TG 500-2000 mg/dL (off of TG-lowering medications-see below)
- Age 35-75 years
Key exclusion criteria (15 listed)
- Use of Lovaza (2g/d or more) or high-dose dietary supplement omega-3 oil (4g/d or more) in the past 2 months
- Use of lipid therapy (statin, ezetimibe, fibrate, BAS, or niacin at therapeutic dose, 1g/d or higher) in the past 3 weeks (washout of prior therapy permitted)
- Anticipated need to change type or dose of BP medicine (all types allowed), of lipid-active diabetes medication (thiazolidinedione), of oral estrogen (BCP or HRT), or glucocorticoid during the study (16 + 2 weeks = 18 weeks total)
- Excess ethanol consumption (regular intake >4 drinks/d, or binges of >8 drinks at once for men, half these levels for women)
- Poorly controlled diabetes mellitus (A1c >9%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lovaza (Omega-3 acid ethyl esters)Also: Lovaza1g capsules, 4 capsules po daily | Drug | Lovaza |
| PlaceboPlacebo matching active lovaza, 1 g capsules, 4 capsules po daily | Drug | Placebo |
Primary outcome
HDL Composition
Time frame: 12 weeks
HDL composition (protein and lipid) by size (gel filtration column)
2 secondary outcomes
HDL cholesterol composition by density subfraction
Time frame: 12 weeks
Safety
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eliot A Brinton, MD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lovaza (Omega-3 acid ethyl esters) in people with Hypertriglyceridemia, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HDL Composition (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2016.