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

Hypertriglyceridemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00903409
• Other study ID #: 111818
• Secondary ID: LOV111858
• Status: Completed
• Phase: Phase 3
• First received: May 14, 2009
• Last updated: September 8, 2017
• Start date: November 15, 2005
• Est. completion date: June 27, 2008

Study information

• Verified date: September 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: June 27, 2008
• Est. primary completion date: June 27, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

For LOV111818/OM6X - Subjects were included in the study if they had met all relevant inclusion/exclusion criteria prior to and throughout the double-blind Study LOV111858/OM6 and completed Study LOV111858/OM6 to Week 8.

FYI - entry criteria for LOV111818/OM6 (double-blind study)

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Hypertriglyceridemia

Intervention

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

Locations

Country	Name	City	State
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Bloomington	Indiana
United States	GSK Investigational Site	Bristol	Tennessee
United States	GSK Investigational Site	Charlotte	North Carolina
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Dunwoody	Georgia
United States	GSK Investigational Site	Edina	Minnesota
United States	GSK Investigational Site	Encinitas	California
United States	GSK Investigational Site	Evansville	Indiana
United States	GSK Investigational Site	Fresno	California
United States	GSK Investigational Site	Greenbrae	California
United States	GSK Investigational Site	Hickory	North Carolina
United States	GSK Investigational Site	Hollywood	Florida
United States	GSK Investigational Site	Indianapolis	Indiana
United States	GSK Investigational Site	Kansas City	Missouri
United States	GSK Investigational Site	Lakewood	Washington
United States	GSK Investigational Site	Louisville	Kentucky
United States	GSK Investigational Site	Mobile	Alabama
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	Norfolk	Virginia
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Pinellas Park	Florida
United States	GSK Investigational Site	Plano	Texas
United States	GSK Investigational Site	Richmond	Virginia
United States	GSK Investigational Site	Richmond	Virginia
United States	GSK Investigational Site	Sacramento	California
United States	GSK Investigational Site	Salisbury	North Carolina
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	Seattle	Washington
United States	GSK Investigational Site	Statesville	North Carolina
United States	GSK Investigational Site	Suwanee	Georgia
United States	GSK Investigational Site	Tampa	Florida
United States	GSK Investigational Site	Thousand Oaks	California
United States	GSK Investigational Site	Warwick	Rhode Island
United States	GSK Investigational Site	Wentzville	Minnesota
United States	GSK Investigational Site	Wilmington	North Carolina
United States	GSK Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (4)

Bays H, Maki K, McKenney J, et al. Long-term Efficacy of Prescription Omega-3 Fatty Acids Co-administered With Simvastatin in Hypertriglyceridemic Patients. Current Medical Research & Opinion (CMRO) Vol. 26, No. 4, 2010, 907-915.

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Months 4, 12, and 24 (LOV111818) of the open-label extension trial
Secondary	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	LOV111858 End-of-Treatment (Week 8) to LOV111818 Months 4, 12, and 24 of the open-label extension trial

External Links

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