Trial Outcomes & Findings for 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™ (NCT NCT00891293)
NCT ID: NCT00891293
Last Updated: 2011-01-25
Results Overview
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.
COMPLETED
PHASE4
93 participants
Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24
2011-01-25
Participant Flow
Participant milestones
| Measure |
Lovaza (Formerly Known as Omacor) and Fenofibrate
Open-label Lovaza (omega-3-acid ethyl esters)\[formerly known as Omacor\] 4 g/day and open-label fenofibrate 130 mg/day
|
|---|---|
|
Overall Study
STARTED
|
93
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
84
|
Reasons for withdrawal
| Measure |
Lovaza (Formerly Known as Omacor) and Fenofibrate
Open-label Lovaza (omega-3-acid ethyl esters)\[formerly known as Omacor\] 4 g/day and open-label fenofibrate 130 mg/day
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Protocol Violation
|
2
|
|
Overall Study
Laboratory abnormality
|
4
|
|
Overall Study
Lost to Follow-up
|
7
|
|
Overall Study
Subject withdrew consent
|
7
|
|
Overall Study
Sponsor termination
|
62
|
Baseline Characteristics
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™
Baseline characteristics by cohort
| Measure |
Lovaza (Formerly Known as Omacor) and Fenofibrate
n=89 Participants
Open-label Lovaza (omega-3-acid ethyl esters)\[formerly known as Omacor\] 4 g/day and open-label fenofibrate 130 mg/day
|
|---|---|
|
Age Continuous
|
52.4 years
STANDARD_DEVIATION 9.99 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
81 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24Population: 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.
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.
Outcome measures
| Measure |
Lovaza (Formerly Known as Omacor) and Fenofibrate
n=89 Participants
Open-label Lovaza (omega-3-acid ethyl esters)\[formerly known as Omacor\] 4 g/day and open-label fenofibrate 130 mg/day
|
|---|---|
|
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).
LOV111859/OM5 Baseline to LOV111860/OM5X EOT
|
-60.6 Percentage change
Full Range 20.72 • Interval -85.3 to 55.9
|
|
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).
LOV111859/OM5 Baseline to LOV111821/OM5XX EOT
|
-62.0 Percentage change
Full Range 32.33 • Interval -88.9 to 115.0
|
SECONDARY outcome
Timeframe: LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24Population: 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.
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.
Outcome measures
| Measure |
Lovaza (Formerly Known as Omacor) and Fenofibrate
n=89 Participants
Open-label Lovaza (omega-3-acid ethyl esters)\[formerly known as Omacor\] 4 g/day and open-label fenofibrate 130 mg/day
|
|---|---|
|
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 EOT
|
-6.7 Percentage change
Interval -47.6 to 25.3
|
|
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 LOV111821/OM5XX EOT
|
-13.2 Percentage change
Interval -55.1 to 20.1
|
SECONDARY outcome
Timeframe: LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24Population: 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.
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.
Outcome measures
| Measure |
Lovaza (Formerly Known as Omacor) and Fenofibrate
n=89 Participants
Open-label Lovaza (omega-3-acid ethyl esters)\[formerly known as Omacor\] 4 g/day and open-label fenofibrate 130 mg/day
|
|---|---|
|
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 EOT
|
-58.3 Percentage change
Interval -82.2 to 14.9
|
|
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 LOV111821/OM5XX EOT
|
-54.6 Percentage change
Interval -88.4 to 10.5
|
SECONDARY outcome
Timeframe: LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24Population: 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.
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.
Outcome measures
| Measure |
Lovaza (Formerly Known as Omacor) and Fenofibrate
n=89 Participants
Open-label Lovaza (omega-3-acid ethyl esters)\[formerly known as Omacor\] 4 g/day and open-label fenofibrate 130 mg/day
|
|---|---|
|
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 EOT
|
52.8 Percentage change
Interval -24.8 to 147.7
|
|
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 LOV111821/OM5XX EOT
|
37.5 Percentage change
Interval -49.0 to 159.7
|
SECONDARY outcome
Timeframe: LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24Population: 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.
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.
Outcome measures
| Measure |
Lovaza (Formerly Known as Omacor) and Fenofibrate
n=89 Participants
Open-label Lovaza (omega-3-acid ethyl esters)\[formerly known as Omacor\] 4 g/day and open-label fenofibrate 130 mg/day
|
|---|---|
|
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 EOT
|
-3.0 Percentage change
Interval -62.9 to 44.1
|
|
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 LOV111821/OM5XX EOT
|
-11.1 Percentage change
Interval -47.2 to 175.6
|
SECONDARY outcome
Timeframe: LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24Population: 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.
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.
Outcome measures
| Measure |
Lovaza (Formerly Known as Omacor) and Fenofibrate
n=89 Participants
Open-label Lovaza (omega-3-acid ethyl esters)\[formerly known as Omacor\] 4 g/day and open-label fenofibrate 130 mg/day
|
|---|---|
|
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 EOT
|
-4.8 Percentage change
Interval -45.2 to 234.6
|
|
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 LOV111821/OM5XX EOT
|
0 Percentage change
Interval -72.4 to 74.6
|
SECONDARY outcome
Timeframe: LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24Population: 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.
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.
Outcome measures
| Measure |
Lovaza (Formerly Known as Omacor) and Fenofibrate
n=89 Participants
Open-label Lovaza (omega-3-acid ethyl esters)\[formerly known as Omacor\] 4 g/day and open-label fenofibrate 130 mg/day
|
|---|---|
|
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 EOT
|
1.7 Percentage change
Interval -68.6 to 34.4
|
|
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 LOV111821/OM5XX EOT
|
2.9 Percentage change
Interval -20.4 to 179.1
|
SECONDARY outcome
Timeframe: LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24Population: 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.
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.
Outcome measures
| Measure |
Lovaza (Formerly Known as Omacor) and Fenofibrate
n=89 Participants
Open-label Lovaza (omega-3-acid ethyl esters)\[formerly known as Omacor\] 4 g/day and open-label fenofibrate 130 mg/day
|
|---|---|
|
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 EOT
|
0.0 Percentage change
Interval -39.9 to 47.6
|
|
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 LOV111821/OM5XX EOT
|
-7.3 Percentage change
Interval -59.3 to 35.4
|
SECONDARY outcome
Timeframe: LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24Population: 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.
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.
Outcome measures
| Measure |
Lovaza (Formerly Known as Omacor) and Fenofibrate
n=89 Participants
Open-label Lovaza (omega-3-acid ethyl esters)\[formerly known as Omacor\] 4 g/day and open-label fenofibrate 130 mg/day
|
|---|---|
|
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 EOT
|
-7.2 Percentage change
Interval -51.4 to 30.9
|
|
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 LOV111821/OM5XX EOT
|
-13.3 Percentage change
Interval -64.8 to 20.1
|
Adverse Events
Lovaza (Formerly Known as Omacor) and Fenofibrate
Serious adverse events
| Measure |
Lovaza (Formerly Known as Omacor) and Fenofibrate
Open-label Lovaza (omega-3-acid ethyl esters)\[formerly known as Omacor\] 4 g/day and open-label fenofibrate 130 mg/day
|
|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
1.1%
1/89
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.
|
|
Investigations
Elevated liver function
|
1.1%
1/89
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.
|
|
Musculoskeletal and connective tissue disorders
L2-3 herniated lumbar disk
|
1.1%
1/89
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.
|
|
Infections and infestations
R lower extremity cellulitus
|
1.1%
1/89
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.
|
Other adverse events
| Measure |
Lovaza (Formerly Known as Omacor) and Fenofibrate
Open-label Lovaza (omega-3-acid ethyl esters)\[formerly known as Omacor\] 4 g/day and open-label fenofibrate 130 mg/day
|
|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
16.9%
15/89
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.
|
|
Infections and infestations
Influenza
|
6.7%
6/89
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.
|
|
Vascular disorders
Hypertension
|
6.7%
6/89
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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
5/89
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.
|
|
Endocrine disorders
Diabetes
|
5.6%
5/89
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.
|
|
Infections and infestations
Sinusitis
|
5.6%
5/89
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.
|
|
Gastrointestinal disorders
Nausea
|
5.6%
5/89
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.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER