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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: March 24, 2017
Last verified: March 2017
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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: | 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 |
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) ]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 ]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
| Study Start Date: | November 15, 2005 |
| Study Completion Date: | June 1, 2008 |
| Primary Completion Date: | June 1, 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) |
| 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)
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00903409
Show 40 Study Locations
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
Additional 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.
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.
Study Data/Documents: Dataset Specification
Identifier: 111818
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
Study Protocol
Identifier: 111818
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
Clinical Study Report
Identifier: 111818
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
Statistical Analysis Plan
Identifier: 111818
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
Individual Participant Data Set
Identifier: 111818
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
Informed Consent Form
Identifier: 111818
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
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00903409 History of Changes |
| Other Study ID Numbers: |
111818 LOV111858 ( Other Identifier: GSK ) |
| Study First Received: | May 14, 2009 |
| Results First Received: | June 12, 2009 |
| Last Updated: | March 24, 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. |
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 21, 2017