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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

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ClinicalTrials.gov Identifier: NCT00246636
Recruitment Status : Completed
First Posted : October 30, 2005
Last Update Posted : December 14, 2009
Sponsor:
Information provided by:
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE October 28, 2005
First Posted Date  ICMJE October 30, 2005
Last Update Posted Date December 14, 2009
Study Start Date  ICMJE October 2005
Actual Primary Completion Date February 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2009)
  • 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 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 28, 2005)
Change in serum triglycerides
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2009)
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2005)
Changes in other lipid and biomarker levels
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief 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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hypertriglyceridemia
Intervention  ICMJE
  • Drug: Antara (fenofibrate) + Lovaza
    Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor]
  • Drug: Antara (fenofibrate)
    Antara (fenofibrate) + placebo
Study Arms  ICMJE
  • Active Comparator: OM5/LOV111859 (double-blind study) - Antara
    Antara (fenofibrate) + placebo
    Intervention: Drug: Antara (fenofibrate)
  • Experimental: OM5X/LOV111860 (extension study) - Open-Label Antara + Lovaza
    Open-label Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor]
    Interventions:
    • Drug: Antara (fenofibrate) + Lovaza
    • Drug: Antara (fenofibrate)
  • Experimental: OM5/LOV111859 (double-blind study) - Antara + Lovaza
    Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor]
    Intervention: Drug: Antara (fenofibrate) + Lovaza
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 6, 2008)
167
Original Enrollment  ICMJE
 (submitted: October 28, 2005)
150
Actual Study Completion Date  ICMJE March 2007
Actual Primary Completion Date February 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00246636
Other Study ID Numbers  ICMJE OM5 program (Reliant)
OM5/LOV111859 (original study)
OM5X/LOV111860 (1st extension)
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Study Director, GSK
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP