Evaluation of Efficacy and Safety of Omacor (Omega-3-acid Ethyl Esters) as Add-on Therapy in Hypertriglyceridemic Subjects Treated With Antara (Fenofibrate) Followed by an 8-week Extension
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertriglyceridemia
Intervention: Antara (fenofibrate) + Lovaza (Drug); Antara (fenofibrate) (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
Summary
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: OM5X/LOV111860 - Difference between double-blind Lovaza (omega-3-acid ethyl esters) + fenofibrate (Group 1) and placebo + fenofibrate (Group 2) treatment groups in percent change in fasting serum TG level from baseline of OM5 to end of OM5XOM5/LOV111859 - Difference between Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor]+ fenofibrate and placebo + fenofibrate treatment groups in percent change in TG level from baseline
Secondary outcome: OM5X/LOV111860 - Difference between double-blind Lovaza (omega-3-acid ethyl esters) + fenofibrate (Group 1) and placebo + fenofibrate (Group 2) treatment groups in percent change for other lipid and biomarkers from baseline of OM5 to end of OM5XOM5/LOV111859 - Difference between Lovaza (omega-3-acid ethyl esters) + fenofibrate and placebo + fenofibrate treatment groups in percent change for other lipid and biomarkers from baseline
Detailed description:
Three studies comprise this OM5 Program
- Study OM5 / LOV111859 (double-blind study) and OM5X / LOV111860 (1st open-label
extension) are part of this listing on ClinicalTrials. gov - NCT00246636.
- Study OM5XX / LOV111821 (2nd open-label extension) is listed as a separate listing on
ClinicalTrials. gov - NCT00891293
Eligibility
Minimum age: 18 Years.
Maximum age: 79 Years.
Gender(s): Both.
Criteria:
For OM5/LOV111858 -
Inclusion Criteria:
- Men and women ages 18-79 years, inclusive
- Triglyceride levels between 500 mg/dL and <1300 mg/dL
- Body mass index between 25 and 43 kg/m2
- Willingness to follow a low-saturated fat diet during the study period and maintain
current physical activity level
- 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 fibrate drugs or omega-3 fatty acids
- Lipoprotein lipase impairment or apo C-2 deficiency or Type III hyperlipidemia
- History of pancreatitis
- Recent history of certain kidney, liver, lung, or gastrointestinal disease or cancer
(except non-melanoma skin cancer)
- Poorly controlled diabetes mellitus
- Type 1 diabetes
- 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 isotretinoin (Accutane)
- Use of warfarin (Coumadin)
For OM5X/LOV111859 -
Subjects were included in the study if they met the following criteria:
1. Satisfied all inclusion and exclusion criteria prior to and throughout the previous
OM5 study or had a corresponding approved protocol deviation
2. Successfully completed the previous OM5 double-blind study to Week 8
3. Provided written informed consent on or before the Week 8 clinic visit of the OM5
double-blind study (i. e., Visit 1X of the OM5X extension study)
Locations and Contacts
Additional Information
Starting date: October 2005
Last updated: December 10, 2009
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