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 - Full Text View

Purpose

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	Intervention	Phase
Hypertriglyceridemia	Drug: Simvastatin + Lovaza® (omega-3-acid ethyl esters)	Phase 3


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open-Label Extension of a Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Combined Lovaza® and Simvastatin Therapy in Hypertriglyceridemic Subjects

Resource links provided by NLM:

MedlinePlus related topics: Triglycerides

Drug Information available for: Simvastatin Omega-3-acid ethyl esters Lovaza Omega-3 Fatty Acids

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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) ] [ Designated as safety issue: No ]
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:

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 ] [ Designated as safety issue: No ]
Median percent change from LOV111858 Baseline to LOV111818 Months 4, 12, and 24 visits 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 [ Time Frame: LOV111858 End-of-Treatment (Week 8) to LOV111818 Months 4, 12, and 24 of the open-label extension trial ] [ Designated as safety issue: No ]
Median percent change from LOV111858 End-of-Treatment (Week 8) to LOV111818 Months 4, 12, and 24 visits of the open-label extension trial


Enrollment:	188
Study Start Date:	November 2005
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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]

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.

Eligibility


Ages Eligible for Study:	18 Years to 79 Years (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00903409

Show 40 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

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.


Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00903409 History of Changes
Other Study ID Numbers:	111818
Study First Received:	May 14, 2009
Results First Received:	June 12, 2009
Last Updated:	November 8, 2012
Health Authority:	United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 27, 2016