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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00246636 |
The purpose of OM5/LOV111859 was to evaluate efficacy and safety of Omacor (omega-3-acid ethyl esters) as add-on therapy to Antara (fenofibrate) and diet for the treatment of patients with very high triglycerides.
The purpose of both OM5X/LOV111860 was to assess the continued efficacy and safety of adjunctive Lovaza (omega-3-acid ethyl esters) therapy in hypertriglyceridemic subjects treated with fenofibrate in lowering serum triglyceride (TG) levels.
Condition | Intervention | Phase |
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Hypertriglyceridemia |
Drug: Antara (fenofibrate) + Lovaza Drug: Antara (fenofibrate) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase IV Study to Assess the Efficacy and Safety of Adjunctive Omacor Therapy in Hypertriglyceridemic Subjects Treated With Antara, Followed by an 8-Week Extension |
Enrollment: | 167 |
Study Start Date: | October 2005 |
Study Completion Date: | March 2007 |
Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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OM5/LOV111859 (double-blind study) - Antara: Active Comparator
Antara (fenofibrate) + placebo
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Drug: Antara (fenofibrate)
Antara (fenofibrate) + placebo
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OM5X/LOV111860 (extension study) - Open-Label Antara + Lovaza: Experimental
Open-label Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor]
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Drug: Antara (fenofibrate) + Lovaza
Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor]
Drug: Antara (fenofibrate)
Antara (fenofibrate) + placebo
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OM5/LOV111859 (double-blind study) - Antara + Lovaza: Experimental
Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor]
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Drug: Antara (fenofibrate) + Lovaza
Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor]
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Three studies comprise this OM5 Program
Ages Eligible for Study: | 18 Years to 79 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
For OM5/LOV111858 -
Inclusion Criteria:
Exclusion Criteria:
For OM5X/LOV111859 -
Subjects were included in the study if they met the following criteria:
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | OM5 program (Reliant), OM5/LOV111859 (original study), OM5X/LOV111860 (1st extension) |
Study First Received: | October 28, 2005 |
Last Updated: | May 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00246636 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Very high triglycerides omega-3-acid ethyl esters fenofibrate Lovaza |
Antimetabolites Metabolic Diseases Hyperlipidemias Hypertriglyceridemia Antilipemic Agents |
Omega 3 Fatty Acid Procetofen Metabolic Disorder Dyslipidemias Lipid Metabolism Disorders |
Antimetabolites Metabolic Diseases Hyperlipidemias Hypertriglyceridemia Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Antilipemic Agents Procetofen Pharmacologic Actions Dyslipidemias Lipid Metabolism Disorders |