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HypertriglyceridemiaPhase 3NCT00903409

Open-Label Extension of a Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lovaza® and Simvastatin Therapy in Hypertriglyceridemic Subjects

A Phase 3 study testing Simvastatin + Lovaza® (omega-3-acid ethyl esters) in people with Hypertriglyceridemia, run by GlaxoSmithKline at 40 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In a previous trial (LOV111858/OM6), subjects received in a double-blind fashion either 4 g/day of Lovaza® (omega-3-ethyl esters) [formerly known as Omacor] co-administered with simvastatin 40 mg/day or placebo co-administered with simvastatin 40 mg/day for 8 weeks. Read more about this study

Who is it for?
Ages 18 to 79 years
Conditions the study is for
Hypertriglyceridemia
What is being tested?
Simvastatin + Lovaza® (omega-3-acid ethyl esters)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
188 participants
Where
40 sitesUnited States
Study dates
15 Nov 2005to 27 Jun 2008
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men and women ages 18-79 years, inclusive
  • Current therapy with a statin drug
  • Triglyceride levels between 200 and 499 mg/dL
  • Normally active and in good health on the basis of medical history, brief physical examination, electrocardiogram, and routine laboratory tests
  • Provide written informed consent and authorization for protected health information disclosure

Who cannot join

  • Sensitivity to statin drugs or omega-3 fatty acids
  • Lipoprotein lipase impairment or apo C-2 deficiency or type III hyperlipidemia
  • Unexplained muscle pain or weakness
  • History of pancreatitis
  • Recent history of certain heart, kidney, liver, lung, or gastrointestinal diseases, or cancer (except non-melanoma skin cancer)
  • Poorly controlled diabetes, or receiving insulin therapy
Show all 9Show fewer
  • Pregnant or lactating females. Women of childbearing potential who are not using a medically approved method of contraception.
  • Use of certain types of hormones, anticonvulsant drugs, immunologic drugs, antibiotic, antifungal and antiviral drugs, and cardiac drugs
  • Use of warfarin (Coumadin)

Trial locations and contacts

40 sites in 1 country.

40 sites in 1 country

United States40 sites

  • GSK Investigational Site

    Atlanta, Georgia, 30309

  • GSK Investigational Site

    Baltimore, Maryland, 21209

  • GSK Investigational Site

    Bloomington, Indiana, 47403

  • GSK Investigational Site

    Bristol, Tennessee, 37620

  • GSK Investigational Site

    Charlotte, North Carolina, 28209

  • GSK Investigational Site

    Chicago, Illinois, 60610

  • GSK Investigational Site

    Cincinnati, Ohio, 45212

  • GSK Investigational Site

    Cincinnati, Ohio, 45246

  • GSK Investigational Site

    Dunwoody, Georgia, 30328

  • GSK Investigational Site

    Edina, Minnesota, 55435

  • GSK Investigational Site

    Encinitas, California, 92024

  • GSK Investigational Site

    Evansville, Indiana, 47714

  • GSK Investigational Site

    Fresno, California, 93710

  • GSK Investigational Site

    Greenbrae, California, 94904

  • GSK Investigational Site

    Hickory, North Carolina, 28601

  • GSK Investigational Site

    Hollywood, Florida, 33023

  • GSK Investigational Site

    Indianapolis, Indiana, 46260

  • GSK Investigational Site

    Kansas City, Missouri, 64111

  • GSK Investigational Site

    Lakewood, Washington, 98499

  • GSK Investigational Site

    Louisville, Kentucky, 40213

  • GSK Investigational Site

    Mobile, Alabama, 36608

  • GSK Investigational Site

    New York, New York, 10032

  • GSK Investigational Site

    Norfolk, Virginia, 23502

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19111

  • GSK Investigational Site

    Pinellas Park, Florida, 33781

  • GSK Investigational Site

    Plano, Texas, 75093

  • GSK Investigational Site

    Richmond, Virginia, 23249

  • GSK Investigational Site

    Richmond, Virginia, 23294

  • GSK Investigational Site

    Sacramento, California, 95831

  • GSK Investigational Site

    Salisbury, North Carolina, 28144

  • GSK Investigational Site

    San Antonio, Texas, 78229

  • GSK Investigational Site

    Seattle, Washington, 98104

  • GSK Investigational Site

    Statesville, North Carolina, 28677

  • GSK Investigational Site

    Suwanee, Georgia, 30024

  • GSK Investigational Site

    Tampa, Florida, 33606

  • GSK Investigational Site

    Thousand Oaks, California, 91360

  • GSK Investigational Site

    Warwick, Rhode Island, 02886

  • GSK Investigational Site

    Wentzville, Minnesota, 62285

  • GSK Investigational Site

    Wilmington, North Carolina, 28412

  • GSK Investigational Site

    Winston-Salem, North Carolina, 27106

Other trials in United States

About this study

Official title: OM6X: An Open-Label Extension of a Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Combined Lovaza (Previously Omacor®) and Simvastatin Therapy in Hypertriglyceridemic Subjects

In a previous trial (LOV111858/OM6), subjects received in a double-blind fashion either 4 g/day of Lovaza® (omega-3-ethyl esters) [formerly known as Omacor] co-administered with simvastatin 40 mg/day or placebo co-administered with simvastatin 40 mg/day for 8 weeks. This extension trial, LOV111818/OM6X assessed the continued efficacy and safety of Lovaza® (omega-3-ethyl esters) co-administered with simvastatin 40 mg vs. switching from simvastatin plus placebo to simvastatin plus Lovaza® for lowering non-High Density Lipoprotein-Cholesterol (non-HDL-C) levels at 4 months (primary endpoint) and additionally at 12 and 24 months.

Read the detailed description

Two studies comprise this OM6 Program. Study LOV111858/OM6 (double-blind study) which is outlined in NCT00246701 and Study LOV111818/OM6X (open-label extension) outlined in this posting.

Being tested
Simvastatin + Lovaza® (omega-3-acid ethyl esters)
Keywords
High triglycerides, Lovaza, simvastatin, omega-3-acid ethyl esters
Medical subject headings
Hypertriglyceridemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Simvastatin + Lovaza® (omega-3-acid ethyl esters)Drug

    Open-label Simvastatin + Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor]

Study groups in NCT00903409
Study groupRoleWhat they receive
Simvastatin + Lovaza® ("Non-switchers")ExperimentalOpen label Simvastatin + Lovaza® (omega-3-acid ethyl esters) NOTE: this group was originally assigned to Simvastatin + Lovaza® in the double-blind trial, hence in this open-label extension, they are termed "Non-switchers"
Receives: Drug: Simvastatin + Lovaza® (omega-3-acid ethyl esters)
Simvastatin + Lovaza® ("Switchers")ExperimentalOpen label Simvastatin + Lovaza® (omega-3-acid ethyl esters) NOTE: this group was originally assigned to Simvastatin + placebo in the double-blind trial, hence in this open-label extension, they are termed "Switchers"
Receives: Drug: Simvastatin + Lovaza® (omega-3-acid ethyl esters)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Median Percent Change of Non-HDL-C (High Density Lipoprotein-Cholesterol) in Switchers vs. Non-Switchers Subjects From LOV111858 End-of-Treatment (Week 8) to Month 4 of Extension Study (LOV111818)

    Median percent change from LOV111858 (NCT00903409) End-of-Treatment (double-blind study, Week 8) to the Month 4 visit of LOV111818 (open-label extension trial)

    Measured: Month 4 (LOV111818)

Secondary outcomes (2)

  1. Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in "Switchers" vs. Non-switchers

    Median percent change from LOV111858 Baseline to LOV111818 Months 4, 12, and 24 visits of the open-label extension trial

    Measured: Months 4, 12, and 24 (LOV111818) of the open-label extension trial

  2. Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial

    Median percent change from LOV111858 End-of-Treatment (Week 8) to LOV111818 Months 4, 12, and 24 visits of the open-label extension trial

    Measured: LOV111858 End-of-Treatment (Week 8) to LOV111818 Months 4, 12, and 24 of the open-label extension trial

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2009 (estimated)
  2. Study start15 Nov 2005
  3. Primary completion27 Jun 2008
  4. Study completion27 Jun 2008

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Enrolment
188 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00903409
Sponsor's protocol ID
111818
Other IDs
LOV111858
Status last verified
Sep 2017
First submitted
14 May 2009
Last updated
9 Oct 2017
Data monitoring committee
No
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

  • Bays HE, Maki KC, McKenney J, Snipes R, Meadowcroft A, Schroyer R, Doyle RT, Stein E. Long-term up to 24-month efficacy and safety of concomitant prescription omega-3-acid ethyl esters and simvastatin in hypertriglyceridemic patients. Curr Med Res Opin. 2010 Apr;26(4):907-15. doi: 10.1185/03007991003645318.

    PubMed 20156032

  • Maki KC, Davidson MH, Doyle RT, Ballantyne C. Effect of Prescription Omega-3 Fatty Acids on Non-HDL Cholesterol (Stratified by Baseline LDL Cholesterol Level) in Statin-Treated Patients With Hypertriglyceridemia: COMBOS LDL Tertile Analysis Short Clinical Communication . [Am J Cardiol]. 2010;105(10):1409-12.

  • Maki KC, Dicklin MR, Davidson MH, Doyle RT, Ballantyne CM; COMBination of prescription Omega-3 with Simvastatin (COMBOS) Investigators. Baseline lipoprotein lipids and low-density lipoprotein cholesterol response to prescription omega-3 acid ethyl ester added to Simvastatin therapy. Am J Cardiol. 2010 May 15;105(10):1409-12. doi: 10.1016/j.amjcard.2009.12.063. Epub 2010 Mar 30.

    PubMed 20451686

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Simvastatin + Lovaza® (omega-3-acid ethyl esters) in people with Hypertriglyceridemia, run by GlaxoSmithKline at 40 sites 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 5 inclusion and 9 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: finished, as of the sponsor's last update on 9 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Median Percent Change of Non-HDL-C (High Density Lipoprotein-Cholesterol) in Switchers vs. Non-Switchers Subjects From LOV111858 End-of-Treatment (Week 8) to Month 4 of Extension Study (LOV111818) (time frame: Month 4 (LOV111818)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00903409, which also lists 3 linked publications.

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 9 Oct 2017.

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