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
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00903409
First received: May 14, 2009
Last updated: November 8, 2012
Last verified: November 2012
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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:
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 |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00903409
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Hide Study LocationsLocations
| United States, Alabama | |
| GSK Investigational Site | |
| Mobile, Alabama, United States, 36608 | |
| United States, California | |
| GSK Investigational Site | |
| Encinitas, California, United States, 92024 | |
| GSK Investigational Site | |
| Fresno, California, United States, 93710 | |
| GSK Investigational Site | |
| Greenbrae, California, United States, 94904 | |
| GSK Investigational Site | |
| Sacramento, California, United States, 95831 | |
| GSK Investigational Site | |
| Thousand Oaks, California, United States, 91360 | |
| United States, Florida | |
| GSK Investigational Site | |
| Hollywood, Florida, United States, 33023 | |
| GSK Investigational Site | |
| Pinellas Park, Florida, United States, 33781 | |
| GSK Investigational Site | |
| Tampa, Florida, United States, 33606 | |
| United States, Georgia | |
| GSK Investigational Site | |
| Atlanta, Georgia, United States, 30309 | |
| GSK Investigational Site | |
| Dunwoody, Georgia, United States, 30328 | |
| GSK Investigational Site | |
| Suwanee, Georgia, United States, 30024 | |
| United States, Illinois | |
| GSK Investigational Site | |
| Chicago, Illinois, United States, 60610 | |
| United States, Indiana | |
| GSK Investigational Site | |
| Bloomington, Indiana, United States, 47403 | |
| GSK Investigational Site | |
| Evansville, Indiana, United States, 47714 | |
| GSK Investigational Site | |
| Indianapolis, Indiana, United States, 46260 | |
| United States, Kentucky | |
| GSK Investigational Site | |
| Louisville, Kentucky, United States, 40213 | |
| United States, Maryland | |
| GSK Investigational Site | |
| Baltimore, Maryland, United States, 21209 | |
| United States, Minnesota | |
| GSK Investigational Site | |
| Edina, Minnesota, United States, 55435 | |
| GSK Investigational Site | |
| Wentzville, Minnesota, United States, 62285 | |
| United States, Missouri | |
| GSK Investigational Site | |
| Kansas City, Missouri, United States, 64111 | |
| United States, New York | |
| GSK Investigational Site | |
| New York, New York, United States, 10032 | |
| United States, North Carolina | |
| GSK Investigational Site | |
| Charlotte, North Carolina, United States, 28209 | |
| GSK Investigational Site | |
| Hickory, North Carolina, United States, 28601 | |
| GSK Investigational Site | |
| Salisbury, North Carolina, United States, 28144 | |
| GSK Investigational Site | |
| Statesville, North Carolina, United States, 28677 | |
| GSK Investigational Site | |
| Wilmington, North Carolina, United States, 28412 | |
| GSK Investigational Site | |
| Winston-Salem, North Carolina, United States, 27106 | |
| United States, Ohio | |
| GSK Investigational Site | |
| Cincinnati, Ohio, United States, 45212 | |
| GSK Investigational Site | |
| Cincinnati, Ohio, United States, 45246 | |
| United States, Pennsylvania | |
| GSK Investigational Site | |
| Philadelphia, Pennsylvania, United States, 19111 | |
| United States, Rhode Island | |
| GSK Investigational Site | |
| Warwick, Rhode Island, United States, 02886 | |
| United States, Tennessee | |
| GSK Investigational Site | |
| Bristol, Tennessee, United States, 37620 | |
| United States, Texas | |
| GSK Investigational Site | |
| Plano, Texas, United States, 75093 | |
| GSK Investigational Site | |
| San Antonio, Texas, United States, 78229 | |
| United States, Virginia | |
| GSK Investigational Site | |
| Norfolk, Virginia, United States, 23502 | |
| GSK Investigational Site | |
| Richmond, Virginia, United States, 23249 | |
| GSK Investigational Site | |
| Richmond, Virginia, United States, 23294 | |
| United States, Washington | |
| GSK Investigational Site | |
| Lakewood, Washington, United States, 98499 | |
| GSK Investigational Site | |
| Seattle, Washington, United States, 98104 | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
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.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 Hypolipidemic Agents Antimetabolites |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Lipid Regulating Agents Therapeutic Uses Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Enzyme Inhibitors |
ClinicalTrials.gov processed this record on June 18, 2013