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
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
2 other identifiers
interventional
188
1 country
40
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Nov 2005
Typical duration for phase_3
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 27, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 27, 2008
CompletedFirst Submitted
Initial submission to the registry
May 14, 2009
CompletedFirst Posted
Study publicly available on registry
May 18, 2009
CompletedResults Posted
Study results publicly available
August 4, 2009
CompletedOctober 9, 2017
September 1, 2017
2.6 years
May 14, 2009
June 12, 2009
September 8, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (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)
Month 4 (LOV111818)
Secondary Outcomes (2)
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
Months 4, 12, and 24 (LOV111818) of the open-label extension trial
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
LOV111858 End-of-Treatment (Week 8) to LOV111818 Months 4, 12, and 24 of the open-label extension trial
Study Arms (2)
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"
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"
Interventions
Open-label Simvastatin + Lovaza® (omega-3-acid ethyl esters) \[formerly known as Omacor\]
Eligibility Criteria
You may not qualify if:
- FYI - entry criteria for LOV111818/OM6 (double-blind study)
- 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
- 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
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (40)
GSK Investigational Site
Mobile, Alabama, 36608, United States
GSK Investigational Site
Encinitas, California, 92024, United States
GSK Investigational Site
Fresno, California, 93710, United States
GSK Investigational Site
Greenbrae, California, 94904, United States
GSK Investigational Site
Sacramento, California, 95831, United States
GSK Investigational Site
Thousand Oaks, California, 91360, United States
GSK Investigational Site
Hollywood, Florida, 33023, United States
GSK Investigational Site
Pinellas Park, Florida, 33781, United States
GSK Investigational Site
Tampa, Florida, 33606, United States
GSK Investigational Site
Atlanta, Georgia, 30309, United States
GSK Investigational Site
Dunwoody, Georgia, 30328, United States
GSK Investigational Site
Suwanee, Georgia, 30024, United States
GSK Investigational Site
Chicago, Illinois, 60610, United States
GSK Investigational Site
Bloomington, Indiana, 47403, United States
GSK Investigational Site
Evansville, Indiana, 47714, United States
GSK Investigational Site
Indianapolis, Indiana, 46260, United States
GSK Investigational Site
Louisville, Kentucky, 40213, United States
GSK Investigational Site
Baltimore, Maryland, 21209, United States
GSK Investigational Site
Edina, Minnesota, 55435, United States
GSK Investigational Site
Wentzville, Minnesota, 62285, United States
GSK Investigational Site
Kansas City, Missouri, 64111, United States
GSK Investigational Site
New York, New York, 10032, United States
GSK Investigational Site
Charlotte, North Carolina, 28209, United States
GSK Investigational Site
Hickory, North Carolina, 28601, United States
GSK Investigational Site
Salisbury, North Carolina, 28144, United States
GSK Investigational Site
Statesville, North Carolina, 28677, United States
GSK Investigational Site
Wilmington, North Carolina, 28412, United States
GSK Investigational Site
Winston-Salem, North Carolina, 27106, United States
GSK Investigational Site
Cincinnati, Ohio, 45212, United States
GSK Investigational Site
Cincinnati, Ohio, 45246, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19111, United States
GSK Investigational Site
Warwick, Rhode Island, 02886, United States
GSK Investigational Site
Bristol, Tennessee, 37620, United States
GSK Investigational Site
Plano, Texas, 75093, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
Norfolk, Virginia, 23502, United States
GSK Investigational Site
Richmond, Virginia, 23249, United States
GSK Investigational Site
Richmond, Virginia, 23294, United States
GSK Investigational Site
Lakewood, Washington, 98499, United States
GSK Investigational Site
Seattle, Washington, 98104, United States
Related Publications (2)
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.
PMID: 20156032BACKGROUNDMaki 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.
PMID: 20451686BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Only Adverse Experience categories with a greater than 5% occurrence in any group were reported in the AE table.
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2009
First Posted
May 18, 2009
Study Start
November 15, 2005
Primary Completion
June 27, 2008
Study Completion
June 27, 2008
Last Updated
October 9, 2017
Results First Posted
August 4, 2009
Record last verified: 2017-09
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.