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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™

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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

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hypertriglyceridemia
Intervention Drug: Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters)
Enrollment 93
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lovaza (Formerly Known as Omacor) and Fenofibrate
Hide Arm/Group Description Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
Period Title: Overall Study
Started 93 [1]
Completed 9
Not Completed 84
Reason Not Completed
Adverse Event             2
Protocol Violation             2
Laboratory abnormality             4
Lost to Follow-up             7
Subject withdrew consent             7
Sponsor termination             62
[1]
93 participants were enrolled; baseline data are provided for 89 participants (Safety Population).
Arm/Group Title Lovaza (Formerly Known as Omacor) and Fenofibrate
Hide Arm/Group Description Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
Overall Number of Baseline Participants 89
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 89 participants
52.4  (9.99)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 89 participants
Female
20
  22.5%
Male
69
  77.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 89 participants
White 81
Hispanic or Latino 2
American Indian or Alaska Native 1
Asian 3
Black or African American 2
1.Primary Outcome
Title 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).
Hide Description 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.
Time Frame Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-To-Treat (MITT) Population is defined as subjects who have a baseline assessment in Study LOV111859/OM5 and at least one on-therapy Study LOV111821/OM5XX efficacy assessment.
Arm/Group Title Lovaza (Formerly Known as Omacor) and Fenofibrate
Hide Arm/Group Description:
Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
Overall Number of Participants Analyzed 89
Median (Full Range)
Unit of Measure: Percentage change
LOV111859/OM5 Baseline to LOV111860/OM5X EOT
-60.6
(-85.3 to 55.9)
LOV111859/OM5 Baseline to LOV111821/OM5XX EOT
-62.0
(-88.9 to 115.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lovaza (Formerly Known as Omacor) and Fenofibrate
Comments For the MITT analysis, the method of last observation carried forward (LOCF) was applied. The LOCF is the value of a previous non-baseline visit (post-enrollment) carried forward to the subsequent visit, if missing.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9999
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 3.3
Confidence Interval 95%
-2.8 to 9.4
Parameter Dispersion
Type: Standard Deviation
Value: 29.01
Estimation Comments Difference Between Percent Change from LOV111859/OM5 Baseline to LOV111860/OM5X End-of-Treatment and Percent Change from LOV111859/OM5 Baseline to LOV111821/OM5XX End-of-Treatment
2.Secondary Outcome
Title 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).
Hide Description 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.
Time Frame LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
MITT Population is defined as subjects who have a baseline assessment in Study LOV111859/OM5 and at least one on-therapy Study LOV111821/OM5XX efficacy assessment.
Arm/Group Title Lovaza (Formerly Known as Omacor) and Fenofibrate
Hide Arm/Group Description:
Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
Overall Number of Participants Analyzed 89
Median (Full Range)
Unit of Measure: Percentage change
LOV111859/OM5 Baseline to LOV111860/OM5X EOT
-6.7
(-47.6 to 25.3)
LOV111859/OM5 Baseline to LOV111821/OM5XX EOT
-13.2
(-55.1 to 20.1)
3.Secondary Outcome
Title 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)
Hide Description 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.
Time Frame LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
MITT Population is defined as subjects who have a baseline assessment in Study LOV111859/OM5 and at least one on-therapy Study LOV111821/OM5XX efficacy assessment.
Arm/Group Title Lovaza (Formerly Known as Omacor) and Fenofibrate
Hide Arm/Group Description:
Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
Overall Number of Participants Analyzed 89
Median (Full Range)
Unit of Measure: Percentage change
LOV111859/OM5 Baseline to LOV111860/OM5X EOT
-58.3
(-82.2 to 14.9)
LOV111859/OM5 Baseline to LOV111821/OM5XX EOT
-54.6
(-88.4 to 10.5)
4.Secondary Outcome
Title 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)
Hide Description 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.
Time Frame LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
MITT Population is defined as subjects who have a baseline assessment in Study LOV111859/OM5 and at least one on-therapy Study LOV111821/OM5XX efficacy assessment.
Arm/Group Title Lovaza (Formerly Known as Omacor) and Fenofibrate
Hide Arm/Group Description:
Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
Overall Number of Participants Analyzed 89
Median (Full Range)
Unit of Measure: Percentage change
LOV111859/OM5 Baseline to LOV111860/OM5X EOT
52.8
(-24.8 to 147.7)
LOV111859/OM5 Baseline to LOV111821/OM5XX EOT
37.5
(-49.0 to 159.7)
5.Secondary Outcome
Title 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)
Hide Description 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.
Time Frame LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
MITT Population is defined as subjects who have a baseline assessment in Study LOV111859/OM5 and at least one on-therapy Study LOV111821/OM5XX efficacy assessment.
Arm/Group Title Lovaza (Formerly Known as Omacor) and Fenofibrate
Hide Arm/Group Description:
Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
Overall Number of Participants Analyzed 89
Median (Full Range)
Unit of Measure: Percentage change
LOV111859/OM5 Baseline to LOV111860/OM5X EOT
-3.0
(-62.9 to 44.1)
LOV111859/OM5 Baseline to LOV111821/OM5XX EOT
-11.1
(-47.2 to 175.6)
6.Secondary Outcome
Title 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)
Hide Description 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.
Time Frame LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
MITT Population is defined as subjects who have a baseline assessment in Study LOV111859/OM5 and at least one on-therapy Study LOV111821/OM5XX efficacy assessment.
Arm/Group Title Lovaza (Formerly Known as Omacor) and Fenofibrate
Hide Arm/Group Description:
Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
Overall Number of Participants Analyzed 89
Median (Full Range)
Unit of Measure: Percentage change
LOV111859/OM5 Baseline to LOV111860/OM5X EOT
-4.8
(-45.2 to 234.6)
LOV111859/OM5 Baseline to LOV111821/OM5XX EOT
0
(-72.4 to 74.6)
7.Secondary Outcome
Title 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
Hide Description 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.
Time Frame LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
MITT Population is defined as subjects who have a baseline assessment in Study LOV111859/OM5 and at least one on-therapy Study LOV111821/OM5XX efficacy assessment.
Arm/Group Title Lovaza (Formerly Known as Omacor) and Fenofibrate
Hide Arm/Group Description:
Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
Overall Number of Participants Analyzed 89
Median (Full Range)
Unit of Measure: Percentage change
LOV111859/OM5 Baseline to LOV111860/OM5X EOT
1.7
(-68.6 to 34.4)
LOV111859/OM5 Baseline to LOV111821/OM5XX EOT
2.9
(-20.4 to 179.1)
8.Secondary Outcome
Title 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)
Hide Description 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.
Time Frame LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
MITT Population is defined as subjects who have a baseline assessment in Study LOV111859/OM5 and at least one on-therapy Study LOV111821/OM5XX efficacy assessment.
Arm/Group Title Lovaza (Formerly Known as Omacor) and Fenofibrate
Hide Arm/Group Description:
Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
Overall Number of Participants Analyzed 89
Median (Full Range)
Unit of Measure: Percentage change
LOV111859/OM5 Baseline to LOV111860/OM5X EOT
0.0
(-39.9 to 47.6)
LOV111859/OM5 Baseline to LOV111821/OM5XX EOT
-7.3
(-59.3 to 35.4)
9.Secondary Outcome
Title 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)
Hide Description 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.
Time Frame LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
MITT Population is defined as subjects who have a baseline assessment in Study LOV111859/OM5 and at least one on-therapy Study LOV111821/OM5XX efficacy assessment.
Arm/Group Title Lovaza (Formerly Known as Omacor) and Fenofibrate
Hide Arm/Group Description:
Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
Overall Number of Participants Analyzed 89
Median (Full Range)
Unit of Measure: Percentage change
LOV111859/OM5 Baseline to LOV111860/OM5X EOT
-7.2
(-51.4 to 30.9)
LOV111859/OM5 Baseline to LOV111821/OM5XX EOT
-13.3
(-64.8 to 20.1)
Time Frame [Not Specified]
Adverse Event Reporting Description While 93 subjects were enrolled in the study, information for serious adverse events and other adverse events is provided for 89 subjects. These 89 subjects represent the Safety Population. The Safety Population is defined as all subjects who received a dose of study medication and had at least one post-enrollment safety assessment.
 
Arm/Group Title Lovaza (Formerly Known as Omacor) and Fenofibrate
Hide Arm/Group Description Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
All-Cause Mortality
Lovaza (Formerly Known as Omacor) and Fenofibrate
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Lovaza (Formerly Known as Omacor) and Fenofibrate
Affected / at Risk (%)
Total   4 
Cardiac disorders   
Acute myocardial infarction  1  1/89 (1.12%) 
Infections and infestations   
R lower extremity cellulitus  1  1/89 (1.12%) 
Investigations   
Elevated liver function  1  1/89 (1.12%) 
Musculoskeletal and connective tissue disorders   
L2-3 herniated lumbar disk  1  1/89 (1.12%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lovaza (Formerly Known as Omacor) and Fenofibrate
Affected / at Risk (%)
Total   47 
Endocrine disorders   
Diabetes  1  5/89 (5.62%) 
Gastrointestinal disorders   
Nausea  1  5/89 (5.62%) 
Infections and infestations   
Upper respiratory tract infection  1  15/89 (16.85%) 
Influenza  1  6/89 (6.74%) 
Sinusitis  1  5/89 (5.62%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  5/89 (5.62%) 
Vascular disorders   
Hypertension  1  6/89 (6.74%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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).
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
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 Submitted: April 30, 2009
First Posted: May 1, 2009
Results First Submitted: May 6, 2009
Results First Posted: July 28, 2009
Last Update Posted: January 25, 2011