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™

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00891293
• Collaborator: (none)
• Enrollment: 93
• Locations: 32
• Arm: 1
• Duration (Months): 26
• Patients Per Site: 2.9
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Study Design

• Study Type: Interventional
• 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: Mar 1, 2006
• Actual Primary Completion Date: May 1, 2008
• Actual Study Completion Date: May 1, 2008

Arms and Interventions

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]

Outcome Measures

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). [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). [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) [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) [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) [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) [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 [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) [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) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 79 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Spring Valley	California	United States	91978
2	GSK Investigational Site	Washington	District of Columbia	United States	20037
3	GSK Investigational Site	Coral Gables	Florida	United States	33134
4	GSK Investigational Site	Hollywood	Florida	United States	33023
5	GSK Investigational Site	Jacksonville	Florida	United States	32216
6	GSK Investigational Site	Jacksonville	Florida	United States	32259
7	GSK Investigational Site	Longwood	Florida	United States	32779
8	GSK Investigational Site	Pinellas Park	Florida	United States	33781
9	GSK Investigational Site	Duhwoody	Georgia	United States	30338
10	GSK Investigational Site	Chicago	Illinois	United States	60610
11	GSK Investigational Site	Bloomington	Indiana	United States	47403
12	GSK Investigational Site	Louisville	Kentucky	United States	40213
13	GSK Investigational Site	Auburn	Maine	United States	04210
14	GSK Investigational Site	Scarborough	Maine	United States	04074
15	GSK Investigational Site	Baltimore	Maryland	United States	21209
16	GSK Investigational Site	Wentzville	Minnesota	United States	62285
17	GSK Investigational Site	Kansas City	Missouri	United States	64111
18	GSK Investigational Site	St. Louis	Missouri	United States	63110
19	GSK Investigational Site	Hickory	North Carolina	United States	28601
20	GSK Investigational Site	Salisbury	North Carolina	United States	28144
21	GSK Investigational Site	Statesville	North Carolina	United States	28677
22	GSK Investigational Site	Winston-Salem	North Carolina	United States	27106
23	GSK Investigational Site	Cincinnati	Ohio	United States	45212
24	GSK Investigational Site	Cincinnati	Ohio	United States	45219
25	GSK Investigational Site	Oklahoma City	Oklahoma	United States	73103
26	GSK Investigational Site	Cumberland	Rhode Island	United States	02864
27	GSK Investigational Site	Mount Pleasant	South Carolina	United States	29464
28	GSK Investigational Site	Bristol	Tennessee	United States	37620
29	GSK Investigational Site	San Antonio	Texas	United States	78229
30	GSK Investigational Site	Norfolk	Virginia	United States	23502
31	GSK Investigational Site	Richmond	Virginia	United States	23294
32	GSK Investigational Site	Winchester	Virginia	United States	22601

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• ClinicalTrials.gov Identifier: NCT00891293
• Other Study ID Numbers: 111821
• First Posted: May 1, 2009
• Last Update Posted: Jan 25, 2011
• Last Verified: Nov 1, 2010

• Keywords provided by , ,: omega-3-acid ethyl esters; Very high triglycerides; Lovaza; fenofibrate
• Additional relevant MeSH terms: Hypertriglyceridemia; Fenofibrate

Study Results

Participant Flow

Arm/Group Title	Lovaza (Formerly Known as Omacor) and Fenofibrate
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
COMPLETED	9
NOT COMPLETED	84

Baseline Characteristics

Arm/Group Title	Lovaza (Formerly Known as Omacor) and Fenofibrate
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 Participants	89
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	52.4 (9.99)
Sex: Female, Male (Count of Participants)
Female	20 22.5%
Male	69 77.5%
Race/Ethnicity, Customized (participants) [Number]
White	81 91%
Hispanic or Latino	2 2.2%
American Indian or Alaska Native	1 1.1%
Asian	3 3.4%
Black or African American	2 2.2%

Outcome Measures

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).
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

Outcome Measure Data

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
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
Measure Participants	89
LOV111859/OM5 Baseline to LOV111860/OM5X EOT	-60.6 (20.72)
LOV111859/OM5 Baseline to LOV111821/OM5XX EOT	-62.0 (32.33)

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
Statistical Test of Hypothesis	p-Value	0.9999
	Comments
	Method	ANOVA
	Comments
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).
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

Outcome Measure Data

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
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
Measure Participants	89
LOV111859/OM5 Baseline to LOV111860/OM5X EOT	-6.7
LOV111859/OM5 Baseline to LOV111821/OM5XX EOT	-13.2

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)
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

Outcome Measure Data

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
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
Measure Participants	89
LOV111859/OM5 Baseline to LOV111860/OM5X EOT	-58.3
LOV111859/OM5 Baseline to LOV111821/OM5XX EOT	-54.6

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)
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

Outcome Measure Data

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
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
Measure Participants	89
LOV111859/OM5 Baseline to LOV111860/OM5X EOT	52.8
LOV111859/OM5 Baseline to LOV111821/OM5XX EOT	37.5

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)
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

Outcome Measure Data

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
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
Measure Participants	89
LOV111859/OM5 Baseline to LOV111860/OM5X EOT	-3.0
LOV111859/OM5 Baseline to LOV111821/OM5XX EOT	-11.1

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)
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

Outcome Measure Data

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
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
Measure Participants	89
LOV111859/OM5 Baseline to LOV111860/OM5X EOT	-4.8
LOV111859/OM5 Baseline to LOV111821/OM5XX EOT	0

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
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

Outcome Measure Data

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
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
Measure Participants	89
LOV111859/OM5 Baseline to LOV111860/OM5X EOT	1.7
LOV111859/OM5 Baseline to LOV111821/OM5XX EOT	2.9

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)
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

Outcome Measure Data

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
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
Measure Participants	89
LOV111859/OM5 Baseline to LOV111860/OM5X EOT	0.0
LOV111859/OM5 Baseline to LOV111821/OM5XX EOT	-7.3

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)
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

Outcome Measure Data

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
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
Measure Participants	89
LOV111859/OM5 Baseline to LOV111860/OM5X EOT	-7.2
LOV111859/OM5 Baseline to LOV111821/OM5XX EOT	-13.3

Adverse Events

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
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 (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Lovaza (Formerly Known as Omacor) and Fenofibrate
	Affected / at Risk (%)	# Events
Total	4/ (NaN)
Cardiac disorders
Acute myocardial infarction	1/89 (1.1%)
Infections and infestations
R lower extremity cellulitus	1/89 (1.1%)
Investigations
Elevated liver function	1/89 (1.1%)
Musculoskeletal and connective tissue disorders
L2-3 herniated lumbar disk	1/89 (1.1%)
Other (Not Including Serious) Adverse Events
	Lovaza (Formerly Known as Omacor) and Fenofibrate
	Affected / at Risk (%)	# Events
Total	47/ (NaN)
Endocrine disorders
Diabetes	5/89 (5.6%)
Gastrointestinal disorders
Nausea	5/89 (5.6%)
Infections and infestations
Upper respiratory tract infection	15/89 (16.9%)
Influenza	6/89 (6.7%)
Sinusitis	5/89 (5.6%)
Musculoskeletal and connective tissue disorders
Back pain	5/89 (5.6%)
Vascular disorders
Hypertension	6/89 (6.7%)

Limitations/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).

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.