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

December 10, 2009 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

167

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: OM5/LOV111859 (double-blind study) - Antara
Antara (fenofibrate) + placebo
Drug: Antara (fenofibrate)
Antara (fenofibrate) + placebo
Experimental: OM5X/LOV111860 (extension study) - Open-Label Antara + Lovaza
Open-label Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor]
Drug: Antara (fenofibrate)
Antara (fenofibrate) + placebo
Drug: Antara (fenofibrate) + Lovaza
Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor]
Experimental: OM5/LOV111859 (double-blind study) - Antara + Lovaza
Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor]
Drug: Antara (fenofibrate) + Lovaza
Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor]

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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 OM5X
Time Frame: 8 weeks
8 weeks
OM5/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
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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 OM5X
Time Frame: 8 weeks
8 weeks
OM5/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
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

February 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

October 28, 2005

First Submitted That Met QC Criteria

October 28, 2005

First Posted (Estimate)

October 30, 2005

Study Record Updates

Last Update Posted (Estimate)

December 14, 2009

Last Update Submitted That Met QC Criteria

December 10, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OM5 program (Reliant)
  • OM5/LOV111859 (original study)
  • OM5X/LOV111860 (1st extension)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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