A Second Open-Label Extension of a Double-Blind, Parallel, Phase IV Study to Assess the Efficacy and Safety of Adjunctive Lovaza® (Formerly Known as Omacor®) Therapy in Hypertriglyceridemic Subjects Treated With Antara™

NCT00891293 | Completed Phase 4 Results

• 1 other identifier: 111821
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 32

Brief Summary

This was a 24-month, open-label extension study that followed an 8-week double-blind study (Study LOV111859/OM5) and an 8-week, open-label extension study (LOV111860/OM5X). Study LOV111859/OM5 was conducted to evaluate whether combination therapy with Lovaza (omega-3-acid ethyl esters) and Antara (fenofibrate) would result in a greater reduction in serum triglyceride levels in hypertriglyceridemic subjects than treatment with fenofibrate alone. This second extension of 24 months was to assess the continued efficacy of adjunctive Lovaza (omega-3-acid ethyl esters) \[formerly known as Omacor\] therapy in hypertriglyceridemic subjects treated with Antara (fenofibrate) in lowering serum triglyceride (TG) levels.

Conditions

Hypertriglyceridemia

Keywords

omega-3-acid ethyl esters; Very high triglycerides; Lovaza; fenofibrate

Outcome Measures

Primary Outcomes (1)

• Percent Change in Serum Triglycerides From LOV111859/OM5 (Double-blind [DB] Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) and From LOV111859/OM5 (DB) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Extension).

  Median Percent Change in Serum Triglycerides from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of Serum Triglycerides from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.

  Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24

Secondary Outcomes (8)

• Percent Change in Total Cholesterol From LOV111859/OM5 (Double-blind [DB] Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) and From LOV111859/OM5 (DB Study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Extension Study).

  LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24

• Percent Change in VLDL-C From LOV111859/OM5 (Double-blind [DB] Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) and From LOV111859/OM5 (DB Study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Extension Study)

  LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24

• Percent Change in LDL-C From LOV111859/OM5 (Double-blind [DB] Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) and From LOV111859/OM5 (DB Study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Extension Study)

  LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24

• Percent Change in HDL-C From LOV111859/OM5 (Double-blind [DB] Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) and From LOV111859/OM5 (DB Study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Extension Study)

  LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24

• Percent Change in Ratio of Total-C:HDL-C From LOV111859/OM5 (Double-blind [DB] Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) and From LOV111859/OM5 (DB Study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Ext. Study)

  LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24

Study Arms (1)

Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters)

EXPERIMENTAL

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

Drug: Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters)

Interventions

Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) DRUG

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

Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters)

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• to79 years of age (inclusive) at screening
• fasting serum TG levels ≥500 mg/dL and \<1300 mg/dL
• BMI ≥ 25 kg/m2 and ≤43 kg/m2.
• Subjects enrolled directly from the end of LOV111860/OM5X into LOV111821/OM5XX.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (32)

GSK Investigational Site

Spring Valley, California, 91978, United States

Location

GSK Investigational Site

Washington D.C., District of Columbia, 20037, United States

Location

GSK Investigational Site

Coral Gables, Florida, 33134, United States

Location

GSK Investigational Site

Hollywood, Florida, 33023, United States

Location

GSK Investigational Site

Jacksonville, Florida, 32216, United States

Location

GSK Investigational Site

Jacksonville, Florida, 32259, United States

Location

GSK Investigational Site

Longwood, Florida, 32779, United States

Location

GSK Investigational Site

Pinellas Park, Florida, 33781, United States

Location

GSK Investigational Site

Duhwoody, Georgia, 30338, United States

Location

GSK Investigational Site

Chicago, Illinois, 60610, United States

Location

GSK Investigational Site

Bloomington, Indiana, 47403, United States

Location

GSK Investigational Site

Louisville, Kentucky, 40213, United States

Location

GSK Investigational Site

Auburn, Maine, 04210, United States

Location

GSK Investigational Site

Scarborough, Maine, 04074, United States

Location

GSK Investigational Site

Baltimore, Maryland, 21209, United States

Location

GSK Investigational Site

Wentzville, Minnesota, 62285, United States

Location

GSK Investigational Site

Kansas City, Missouri, 64111, United States

Location

GSK Investigational Site

St Louis, Missouri, 63110, United States

Location

GSK Investigational Site

Hickory, North Carolina, 28601, United States

Location

GSK Investigational Site

Salisbury, North Carolina, 28144, United States

Location

GSK Investigational Site

Statesville, North Carolina, 28677, United States

Location

GSK Investigational Site

Winston-Salem, North Carolina, 27106, United States

Location

GSK Investigational Site

Cincinnati, Ohio, 45212, United States

Location

GSK Investigational Site

Cincinnati, Ohio, 45219, United States

Location

GSK Investigational Site

Oklahoma City, Oklahoma, 73103, United States

Location

GSK Investigational Site

Cumberland, Rhode Island, 02864, United States

Location

GSK Investigational Site

Mt. Pleasant, South Carolina, 29464, United States

Location

GSK Investigational Site

Bristol, Tennessee, 37620, United States

Location

GSK Investigational Site

San Antonio, Texas, 78229, United States

Location

GSK Investigational Site

Norfolk, Virginia, 23502, United States

Location

GSK Investigational Site

Richmond, Virginia, 23294, United States

Location

GSK Investigational Site

Winchester, Virginia, 22601, United States

Location

Related Publications (1)

• 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: 19597368 BACKGROUND

MeSH Terms

Conditions

Hypertriglyceridemia

Interventions

Fenofibrate; Omacor

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Ketones

Limitations and Caveats

LOV111821/OM5XX was terminated due to the lack of substantial incremental change in the primary endpoint lipid values above that reached in either the original study (LOV111859/OM5) or the first extension study (LOV111860/OM5X).

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 30, 2009
• First Posted: May 1, 2009
• Study Start: March 1, 2006
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: January 25, 2011
• Results First Posted: July 28, 2009

Record last verified: 2010-11

Locations

US (32)