HypertriglyceridemiaPhase 4NCT00246636
Evaluation of Efficacy and Safety of Omacor (Omega-3-acid Ethyl Esters) as Add-on Therapy in Hypertriglyceridemic Subjects Treated With Antara (Fenofibrate) Followed by an 8-week Extension
A Phase 4 study testing Antara (fenofibrate) + Lovaza and Antara (fenofibrate) in people with Hypertriglyceridemia, run by GlaxoSmithKline.
Trial summary
The purpose of OM5/LOV111859 was to evaluate efficacy and safety of Omacor (omega-3-acid ethyl esters) as add-on therapy to Antara (fenofibrate) and diet for the treatment of patients with very high triglycerides. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Hypertriglyceridemia
- What is being tested?
- Antara (fenofibrate) + Lovaza and Antara (fenofibrate)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- No sites listed yet
- Study dates
- Oct 2005to Mar 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women ages 18-79 years, inclusive
- Triglyceride levels between 500 mg/dL and <1300 mg/dL
- Body mass index between 25 and 43 kg/m2
- Willingness to follow a low-saturated fat diet during the study period and maintain current physical activity level
- Normally active and in good health on the basis of medical history, brief physical examination, electrocardiogram, and routine laboratory tests
- Provide written informed consent and authorization for protected health information disclosure
Who cannot join
- Sensitivity to fibrate drugs or omega-3 fatty acids
- Lipoprotein lipase impairment or apo C-2 deficiency or Type III hyperlipidemia
- History of pancreatitis
- Recent history of certain kidney, liver, lung, or gastrointestinal disease or cancer (except non-melanoma skin cancer)
- Poorly controlled diabetes mellitus
- Type 1 diabetes
Show all 15Show fewer
- Pregnant or lactating females. Women of childbearing potential who are not using a medically approved method of contraception.
- Use of certain types of hormones, anticonvulsant drugs, immunologic drugs, antibiotic, antifungal and antiviral drugs, and cardiac drugs
- Use of isotretinoin (Accutane)
- Use of warfarin (Coumadin)
- For OM5X/LOV111859 -
- Subjects were included in the study if they met the following criteria:
- Satisfied all inclusion and exclusion criteria prior to and throughout the previous OM5 study or had a corresponding approved protocol deviation
- Successfully completed the previous OM5 double-blind study to Week 8
- Provided written informed consent on or before the Week 8 clinic visit of the OM5 double-blind study (i.e., Visit 1X of the OM5X extension study)
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase IV Study to Assess the Efficacy and Safety of Adjunctive Omacor Therapy in Hypertriglyceridemic Subjects Treated With Antara, Followed by an 8-week Extension
The purpose of OM5/LOV111859 was to evaluate efficacy and safety of Omacor (omega-3-acid ethyl esters) as add-on therapy to Antara (fenofibrate) and diet for the treatment of patients with very high triglycerides.
The purpose of both OM5X/LOV111860 was to assess the continued efficacy and safety of adjunctive Lovaza (omega-3-acid ethyl esters) therapy in hypertriglyceridemic subjects treated with fenofibrate in lowering serum triglyceride (TG) levels.
Read the detailed description
Three studies comprise this OM5 Program
- Study OM5 / LOV111859 (double-blind study) and OM5X / LOV111860 (1st open-label extension) are part of this listing on ClinicalTrials.gov - NCT00246636.
- Study OM5XX / LOV111821 (2nd open-label extension) is listed as a separate listing on ClinicalTrials.gov - NCT00891293
- Conditions
- Hypertriglyceridemia
- Being tested
- Antara (fenofibrate) + Lovaza, Antara (fenofibrate)
- Keywords
- Very high triglycerides, omega-3-acid ethyl esters, fenofibrate, Lovaza
- Medical subject headings
- Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antara (fenofibrate) + LovazaDrug
Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor]
Antara (fenofibrate)Drug
Antara (fenofibrate) + placebo
| Study group | Role | What they receive |
|---|---|---|
| OM5/LOV111859 (double-blind study) - Antara | Active comparator | Antara (fenofibrate) + placebo Receives: Drug: Antara (fenofibrate) |
| OM5X/LOV111860 (extension study) - Open-Label Antara + Lovaza | Experimental | Open-label Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor] Receives: Drug: Antara (fenofibrate) + Lovaza; Drug: Antara (fenofibrate) |
| OM5/LOV111859 (double-blind study) - Antara + Lovaza | Experimental | Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor] Receives: Drug: Antara (fenofibrate) + Lovaza |
What is being measured
The primary outcome is the main question the study is designed to answer.
OM5X/LOV111860 - Difference between double-blind Lovaza (omega-3-acid ethyl esters) + fenofibrate (Group 1) and placebo + fenofibrate (Group 2) treatment groups in percent change in fasting serum TG level from baseline of OM5 to end of OM5X
Measured: 8 weeks
OM5/LOV111859 - Difference between Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor]+ fenofibrate and placebo + fenofibrate treatment groups in percent change in TG level from baseline
Measured: 8 weeks
Secondary outcomes (2)
OM5X/LOV111860 - Difference between double-blind Lovaza (omega-3-acid ethyl esters) + fenofibrate (Group 1) and placebo + fenofibrate (Group 2) treatment groups in percent change for other lipid and biomarkers from baseline of OM5 to end of OM5X
Measured: 8 weeks
OM5/LOV111859 - Difference between Lovaza (omega-3-acid ethyl esters) + fenofibrate and placebo + fenofibrate treatment groups in percent change for other lipid and biomarkers from baseline
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2005 (estimated)
- Study startOct 2005
- Primary completionFeb 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertriglyceridemiaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00246636
- Sponsor's protocol ID
- OM5 program (Reliant)
- Other IDs
- OM5/LOV111859 (original study), OM5X/LOV111860 (1st extension)
- Status last verified
- Dec 2009
- First submitted
- 28 Oct 2005
- Last updated
- 14 Dec 2009
- Results posted
- No
Publications
Bays HE, Maki KC, Doyle RT, Stein E. The effect of prescription omega-3 fatty acids on body weight after 8 to 16 weeks of treatment for very high triglyceride levels. Postgrad Med. 2009 Sep;121(5):145-50. doi: 10.3810/pgm.2009.09.2061.
PubMed 19820283Roth 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.
PubMed 19597368
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase IV Study to Assess the Efficacy and Safety of Adjunctive Omacor Therapy in Hypertriglyceridemic Subjects Treated With Antara, Followed by an 8-week Extension
- ClinicalTrials.gov ID
- NCT00246636
- Acronym / sponsor ID
- OM5 program (Reliant)
- Conditions
- Hypertriglyceridemia
- Keywords
- Very high triglycerides, omega-3-acid ethyl esters, fenofibrate, Lovaza
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Feb 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 31 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of OM5/LOV111859 was to evaluate efficacy and safety of Omacor (omega-3-acid ethyl esters) as add-on therapy to Antara (fenofibrate) and diet for the treatment of patients with very high triglycerides.
The purpose of both OM5X/LOV111860 was to assess the continued efficacy and safety of adjunctive Lovaza (omega-3-acid ethyl esters) therapy in hypertriglyceridemic subjects treated with fenofibrate in lowering serum triglyceride (TG) levels.
Detailed description
Three studies comprise this OM5 Program
- Study OM5 / LOV111859 (double-blind study) and OM5X / LOV111860 (1st open-label extension) are part of this listing on ClinicalTrials.gov - NCT00246636.
- Study OM5XX / LOV111821 (2nd open-label extension) is listed as a separate listing on ClinicalTrials.gov - NCT00891293
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OM5/LOV111859 (double-blind study) - Antara | Active comparator | Drug: Antara (fenofibrate)Antara (fenofibrate) + placebo |
| OM5X/LOV111860 (extension study) - Open-Label Antara + Lovaza | Experimental | Drug: Antara (fenofibrate) + Lovaza, Drug: Antara (fenofibrate)Open-label Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor] |
| OM5/LOV111859 (double-blind study) - Antara + Lovaza | Experimental | Drug: Antara (fenofibrate) + LovazaAntara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor] |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women ages 18-79 years, inclusive
- Triglyceride levels between 500 mg/dL and <1300 mg/dL
- Body mass index between 25 and 43 kg/m2
- Willingness to follow a low-saturated fat diet during the study period and maintain current physical activity level
- Normally active and in good health on the basis of medical history, brief physical examination, electrocardiogram, and routine laboratory tests
Key exclusion criteria (15 listed)
- Sensitivity to fibrate drugs or omega-3 fatty acids
- Lipoprotein lipase impairment or apo C-2 deficiency or Type III hyperlipidemia
- History of pancreatitis
- Recent history of certain kidney, liver, lung, or gastrointestinal disease or cancer (except non-melanoma skin cancer)
- Poorly controlled diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antara (fenofibrate) + LovazaAntara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor] | Drug | OM5/LOV111859 (double-blind study) - Antara + Lovaza, OM5X/LOV111860 (extension study) - Open-Label Antara + Lovaza |
| Antara (fenofibrate)Antara (fenofibrate) + placebo | Drug | OM5/LOV111859 (double-blind study) - Antara, OM5X/LOV111860 (extension study) - Open-Label Antara + Lovaza |
Primary outcome
OM5X/LOV111860 - Difference between double-blind Lovaza (omega-3-acid ethyl esters) + fenofibrate (Group 1) and placebo + fenofibrate (Group 2) treatment groups in percent change in fasting serum TG level from baseline of OM5 to end of OM5X
Time frame: 8 weeks
OM5/LOV111859 - Difference between Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor]+ fenofibrate and placebo + fenofibrate treatment groups in percent change in TG level from baseline
Time frame: 8 weeks
2 secondary outcomes
OM5X/LOV111860 - Difference between double-blind Lovaza (omega-3-acid ethyl esters) + fenofibrate (Group 1) and placebo + fenofibrate (Group 2) treatment groups in percent change for other lipid and biomarkers from baseline of OM5 to end of OM5X
Time frame: 8 weeks
OM5/LOV111859 - Difference between Lovaza (omega-3-acid ethyl esters) + fenofibrate and placebo + fenofibrate treatment groups in percent change for other lipid and biomarkers from baseline
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2009.
- Derived from this study: PubMed 19820283Bays HE, Maki KC, Doyle RT, Stein E. The effect of prescription omega-3 fatty acids on body weight after 8 to 16 weeks of treatment for very high triglyceride levels. Postgrad Med. 2009 Sep;121(5):145-50. doi: 10.3810/pgm.2009.09.2061.
- Derived from this study: PubMed 19597368Roth 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Antara (fenofibrate) + Lovaza and Antara (fenofibrate) in people with Hypertriglyceridemia, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OM5X/LOV111860 - Difference between double-blind Lovaza (omega-3-acid ethyl esters) + fenofibrate (Group 1) and placebo + fenofibrate (Group 2) treatment groups in percent change in fasting serum TG level from baseline of OM5 to end of OM5X (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00246636, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2009; AzTrials last refreshed its copy on 8 Nov 2026.