Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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™

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00891293
Recruitment Status : Completed
First Posted : May 1, 2009
Results First Posted : July 28, 2009
Last Update Posted : January 25, 2011
Sponsor:
Information provided by:
GlaxoSmithKline

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.

Condition or disease Intervention/treatment Phase
Hypertriglyceridemia Drug: Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) Phase 4

Detailed Description:

Three studies comprise this program. Study LOV111859/OM5 (double-blind study) was followed by two open label extensions - LOV111860/OM5X (1st open label extension - 8 weeks) and LOV111821/OM5XX (2nd open label extension - 24 months).

Studies LOV111859/OM5 and LOV111860/OM5X are outlined in NCT00246636.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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™
Study Start Date : March 2006
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Triglycerides

Arm Intervention/treatment
Experimental: Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters)
Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor]
Drug: Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters)
Open-label Antara (fenofibrate) + open-label Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor]




Primary Outcome Measures :
  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). [ Time Frame: Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24 ]
    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.


Secondary Outcome Measures :
  1. 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). [ Time Frame: LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24 ]
    Median Percent Change in Total Cholesterol (Total-C) from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of Total-C from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.

  2. 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) [ Time Frame: LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24 ]
    Median Percent Change in very low density lipoprotein-cholesterol (VLDL-C) from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of VLDL-C from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.

  3. 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) [ Time Frame: LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24 ]
    Median Percent Change in low density lipoprotein-cholesterol (LDL-C) from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of LDL-C from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.

  4. 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) [ Time Frame: LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24 ]
    Median Percent Change in high density lipoprotein-cholesterol (HDL-C) from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of HDL-C from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.

  5. 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) [ Time Frame: LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24 ]
    Median Percent Change in the ratio of total cholesterol (Total-C) to high density lipoprotein-cholesterol (HDL-C) from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change for the ratio of Total-C to HDL-C from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.

  6. Percent Change in Apo A-1 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 [ Time Frame: LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24 ]
    Median Percent Change in apolipoprotein (apo) A-1 from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of apo A-1 from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.

  7. Percent Change in Apo B From LOV111859/OM5 (Double-blind [DB[ Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) From LOV111859/OM5 (DB Study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Extension Study) [ Time Frame: LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24 ]
    Median Percent Change in apolipoprotein (apo) B from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of apo B from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.

  8. Percent Change in Non-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) [ Time Frame: LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24 ]
    Median Percent Change of non- high density lipoprotein-cholesterol (non-HDL-C) from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of non-HDL-C from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Subjects were men and women who had successfully completed the previous open-label extension study (LOV111860/OM5X) and had met all inclusion and exclusion criteria for the original double-blind study (LOV111859/OM5) and throughout LOV111860/OM5X, or who had a renewed waiver of a previously approved protocol deviation.

Eligibility for entry into this study was based on the inclusion/exclusion criteria described of the double-blind LOV111859/OM5 protocol.

Subjects were men and women who had successfully completed the previous open-label extension study (LOV111860/OM5X) and had met all inclusion and exclusion criteria for the original double-blind study (LOV111859/OM5) and throughout LOV111860/OM5X, or who had a renewed waiver of a previously approved protocol deviation. The main eligibility criteria for LOV111859/OM5 were,

  • 18 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00891293


Locations
Layout table for location information
United States, California
GSK Investigational Site
Spring Valley, California, United States, 91978
United States, District of Columbia
GSK Investigational Site
Washington, District of Columbia, United States, 20037
United States, Florida
GSK Investigational Site
Coral Gables, Florida, United States, 33134
GSK Investigational Site
Hollywood, Florida, United States, 33023
GSK Investigational Site
Jacksonville, Florida, United States, 32216
GSK Investigational Site
Jacksonville, Florida, United States, 32259
GSK Investigational Site
Longwood, Florida, United States, 32779
GSK Investigational Site
Pinellas Park, Florida, United States, 33781
United States, Georgia
GSK Investigational Site
Duhwoody, Georgia, United States, 30338
United States, Illinois
GSK Investigational Site
Chicago, Illinois, United States, 60610
United States, Indiana
GSK Investigational Site
Bloomington, Indiana, United States, 47403
United States, Kentucky
GSK Investigational Site
Louisville, Kentucky, United States, 40213
United States, Maine
GSK Investigational Site
Auburn, Maine, United States, 04210
GSK Investigational Site
Scarborough, Maine, United States, 04074
United States, Maryland
GSK Investigational Site
Baltimore, Maryland, United States, 21209
United States, Minnesota
GSK Investigational Site
Wentzville, Minnesota, United States, 62285
United States, Missouri
GSK Investigational Site
Kansas City, Missouri, United States, 64111
GSK Investigational Site
St. Louis, Missouri, United States, 63110
United States, North Carolina
GSK Investigational Site
Hickory, North Carolina, United States, 28601
GSK Investigational Site
Salisbury, North Carolina, United States, 28144
GSK Investigational Site
Statesville, North Carolina, United States, 28677
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27106
United States, Ohio
GSK Investigational Site
Cincinnati, Ohio, United States, 45212
GSK Investigational Site
Cincinnati, Ohio, United States, 45219
United States, Oklahoma
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73103
United States, Rhode Island
GSK Investigational Site
Cumberland, Rhode Island, United States, 02864
United States, South Carolina
GSK Investigational Site
Mount Pleasant, South Carolina, United States, 29464
United States, Tennessee
GSK Investigational Site
Bristol, Tennessee, United States, 37620
United States, Texas
GSK Investigational Site
San Antonio, Texas, United States, 78229
United States, Virginia
GSK Investigational Site
Norfolk, Virginia, United States, 23502
GSK Investigational Site
Richmond, Virginia, United States, 23294
GSK Investigational Site
Winchester, Virginia, United States, 22601
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Layout table for investigator information
Study Director: GSK Clinical Trials GlaxoSmithKline
Publications:
Layout table for additonal information
Responsible Party: E.D. Derilus; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00891293    
Other Study ID Numbers: 111821
First Posted: May 1, 2009    Key Record Dates
Results First Posted: July 28, 2009
Last Update Posted: January 25, 2011
Last Verified: November 2010
Keywords provided by GlaxoSmithKline:
omega-3-acid ethyl esters
Very high triglycerides
Lovaza
fenofibrate
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Fenofibrate
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents