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
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ClinicalTrials.gov Identifier: NCT00903409 |
Recruitment Status
:
Completed
First Posted
: May 18, 2009
Results First Posted
: August 4, 2009
Last Update Posted
: October 9, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypertriglyceridemia | Drug: Simvastatin + Lovaza® (omega-3-acid ethyl esters) | Phase 3 |
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 |

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"
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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]
|
- 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)
- 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
- 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

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00903409

Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Additional Information:
Study Data/Documents: Dataset Specification

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

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

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

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

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

For additional information about this study please refer to the GSK Clinical Study Register
Publications:
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00903409 History of Changes |
Other Study ID Numbers: |
111818 LOV111858 ( Other Identifier: GSK ) |
First Posted: | May 18, 2009 Key Record Dates |
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 |