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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00246701 |
The purpose of OM6 is to evaluate efficacy and safety of Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor] combined with simvastatin for lowering non-high-density lipoprotein cholesterol (non-HDL-C) in subjects with persistent high triglycerides despite statin therapy.
Additionally, a two-year extension trial (LOV111818/OM6X) is posted on NCT00903409.
Condition | Intervention | Phase |
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Hypertriglyceridemia |
Drug: Simvastatin + Lovaza Drug: Simvastatin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Combined Omacor and Simvastatin Therapy in Hypertriglyceridemic Subjects |
Enrollment: | 256 |
Study Start Date: | November 2005 |
Study Completion Date: | June 2006 |
Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Simvastatin: Active Comparator
Simvastatin + placebo
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Drug: Simvastatin
Simvastatin
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Simvastatin + Lovaza: Experimental
Simvastatin + Lovaza (omega-3-acid ethyl esters)
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Drug: Simvastatin + Lovaza
Simvastatin + Lovaza (omega-3-acid ethyl esters)
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Two studies comprise this OM6 Program. Study OM6 / LOV111858 (double-blind study) and is not required to post results based on FDAAA. Study OM6X / LOV111818 (open-label extension) is posted on NCT00903409.
Ages Eligible for Study: | 18 Years to 79 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | OM6 program (Reliant), LOV111858 (OM6) |
Study First Received: | October 28, 2005 |
Last Updated: | June 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00246701 History of Changes |
Health Authority: | United States: Food and Drug Administration |
High triglycerides omega-3-acid ethyl esters simvastatin Lovaza |
Antimetabolites Metabolic Diseases Hyperlipidemias Hypertriglyceridemia Simvastatin Antilipemic Agents |
Omega 3 Fatty Acid Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Metabolic Disorder Dyslipidemias Lipid Metabolism Disorders |
Antimetabolites Hypertriglyceridemia Hyperlipidemias Metabolic Diseases Molecular Mechanisms of Pharmacological Action Simvastatin Antilipemic Agents |
Enzyme Inhibitors Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Therapeutic Uses Dyslipidemias Lipid Metabolism Disorders |