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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Hypertriglyceridemia	Drug: Simvastatin + Lovaza® (omega-3-acid ethyl esters)	Phase 3

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	188 participants
Allocation:	Randomized
Intervention Model:	Single Group Assignment
Primary Purpose:	Treatment
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
Actual Study Start Date :	November 15, 2005
Actual Primary Completion Date :	June 27, 2008
Actual Study Completion Date :	June 27, 2008

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Simvastatin + Lovaza® ("Non-switchers"); Open 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"	Drug: Simvastatin + Lovaza® (omega-3-acid ethyl esters); Open-label Simvastatin + Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor]
Experimental: Simvastatin + Lovaza® ("Switchers"); Open 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"	Drug: Simvastatin + Lovaza® (omega-3-acid ethyl esters); Open-label Simvastatin + Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor]

Outcome Measures

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Primary Outcome Measures :

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) [ Time Frame: Month 4 (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)

Secondary Outcome Measures :

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 [ Time Frame: Months 4, 12, and 24 (LOV111818) of the open-label extension trial ]
   Median percent change from LOV111858 Baseline to LOV111818 Months 4, 12, and 24 visits 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 [ Time Frame: 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

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 79 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

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  Show 40 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

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Additional Information:

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. 

Study Data/Documents: Dataset Specification 

Identifier: 111818
For additional information about this study please refer to the GSK Clinical Study Register

Study Protocol 

Identifier: 111818
For additional information about this study please refer to the GSK Clinical Study Register

Clinical Study Report 

Identifier: 111818
For additional information about this study please refer to the GSK Clinical Study Register

Statistical Analysis Plan 

Identifier: 111818
For additional information about this study please refer to the GSK Clinical Study Register

Individual Participant Data Set 

Identifier: 111818
For additional information about this study please refer to the GSK Clinical Study Register

Informed Consent Form 

Identifier: 111818
For additional information about this study please refer to the GSK Clinical Study Register

Publications:

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.

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.

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00903409 History of Changes
Other Study ID Numbers:	111818; LOV111858 ( Other Identifier: GSK )
First Posted:	May 18, 2009
Results First Posted:	August 4, 2009
Last Update Posted:	October 9, 2017
Last Verified:	September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
URL:	http://

Keywords provided by GlaxoSmithKline:

High triglycerides; Lovaza; simvastatin; omega-3-acid ethyl esters

Additional relevant MeSH terms:

Hypertriglyceridemia; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Simvastatin; Anticholesteremic Agents	Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Enzyme Inhibitors