NCT00246636

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
167

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2005

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 31, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

December 14, 2009

Status Verified

December 1, 2009

Enrollment Period

1.3 years

First QC Date

October 28, 2005

Last Update Submit

December 10, 2009

Conditions

Hypertriglyceridemia

Keywords

Very high triglyceridesomega-3-acid ethyl estersfenofibrateLovaza

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    8 weeks

Secondary Outcomes (2)

  • 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

    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

    8 weeks

Study Arms (3)

OM5/LOV111859 (double-blind study) - Antara

ACTIVE COMPARATOR

Antara (fenofibrate) + placebo

Drug: Antara (fenofibrate)

OM5X/LOV111860 (extension study) - Open-Label Antara + Lovaza

EXPERIMENTAL

Open-label Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) \[formerly known as Omacor\]

Drug: Antara (fenofibrate) + LovazaDrug: Antara (fenofibrate)

OM5/LOV111859 (double-blind study) - Antara + Lovaza

EXPERIMENTAL

Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) \[formerly known as Omacor\]

Drug: Antara (fenofibrate) + Lovaza

Interventions

Antara (fenofibrate) + LovazaDRUG

Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) \[formerly known as Omacor\]

OM5/LOV111859 (double-blind study) - Antara + LovazaOM5X/LOV111860 (extension study) - Open-Label Antara + Lovaza
Antara (fenofibrate)DRUG

Antara (fenofibrate) + placebo

OM5/LOV111859 (double-blind study) - AntaraOM5X/LOV111860 (extension study) - Open-Label Antara + Lovaza

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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:
  • Successfully completed the previous OM5 double-blind study to Week 8
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Bays HE, Maki KC, Doyle RT, Stein E. The effect of prescription omega-3 fatty acids on body weight after 8 to 16 weeks of treatment for very high triglyceride levels. Postgrad Med. 2009 Sep;121(5):145-50. doi: 10.3810/pgm.2009.09.2061.

    PMID: 19820283DERIVED

  • Roth EM, Bays HE, Forker AD, Maki KC, Carter R, Doyle RT, Stein EA. Prescription omega-3 fatty acid as an adjunct to fenofibrate therapy in hypertriglyceridemic subjects. J Cardiovasc Pharmacol. 2009 Sep;54(3):196-203. doi: 10.1097/FJC.0b013e3181b0cf71.

    PMID: 19597368DERIVED

MeSH Terms

Conditions

Hypertriglyceridemia

Interventions

FenofibrateOmacor

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Fibric AcidsIsobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPhenyl EthersEthersBenzophenonesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenolsKetones

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 28, 2005

First Posted

October 31, 2005

Study Start

October 1, 2005

Primary Completion

February 1, 2007

Study Completion

March 1, 2007

Last Updated

December 14, 2009

Record last verified: 2009-12