HypertriglyceridemiaPhase 3NCT01350973

Efficacy of TAK-085 in Participants With Hypertriglyceridemia

A Phase 3 study testing Omega-3-acid ethyl esters 90 (TAK-085) and Eicosapentaenoic acid-ethyl (EPA-E) in people with Hypertriglyceridemia, run by Takeda.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study was to determine the efficacy and safety of TAK-085, once daily (QD) or twice daily (BID), compared to ethyl eicosapentaenoate (EPA-E), three times daily (TID) in participants with hypertriglyceridemia undergoing lifestyle modification. Read more about this study

Who is it for?: Ages 20 to 74 years
Conditions the study is for: Hypertriglyceridemia
What is being tested?: Omega-3-acid ethyl esters 90 (TAK-085) and Eicosapentaenoic acid-ethyl (EPA-E)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 611 participants
Where: No sites listed yet
Study dates: Nov 2009to Dec 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 20 to 74 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participants with values of fasting triglyceride level at Visit 2 (Week -4) and Visit 3 (Week -2) are 150 mg/dL or higher and less than 750 mg/dL, and the difference between these 2 values is within 30% of the higher one.
Participants with differences between 2 values of fasting Low density lipoprotein - cholesterol level measured at Visit 2 (Week -4) and Visit 3 (Week -2) are within 25% of the higher one.

Who cannot join

Participants who have coronary artery diseases (eg, confirmed myocardial infarction and angina pectoris) within 6 months prior to Visit 1 (Week -8) or participants with a history of revascularization.
Participants who received aortic aneurysmectomy or is complicated with aortic aneurysm within 6 months prior to Visit 1 (Week -8).
Participants who have a history or complication of a clinically significant hemorrhagic disease (eg, hemophilia, capillary fragility illness, digestive tract ulcer, urinary tract hemorrhage, hemoptysis, vitreous haemorrhage and so forth) within 6 months prior to Visit 1 (Week -8).
Participants who have been diagnosed with pancreatitis.
Participants who have been diagnosed with lipoprotein lipase (LPL) deficiency, apolipoprotein C-II deficiency or type III familial hyperlipidemia.
Participants with complication of Cushing's syndrome, uremia, systemic lupus erythematosus (SLE) or serum dysproteinemia.

About this study

Official title: A Phase 3, Multicenter, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of TAK-085 in Subjects With Hypertriglyceridemia.

Read the detailed description

TAK-085 is an oral capsule medicine licensed to Takeda Pharmaceutical Company Ltd. TAK-085 contains omega-3 fatty acid ethyl (mainly, ethyl eicosapentaenoate (EPA-E) and ethyl docosahexaenoic acid (DHA-E)).

This is a phase 3, double-blind, randomized study to evaluate the efficacy and safety of TAK-085 compared to EPA-E in participants with hypertriglyceridemia who are undergoing lifestyle modification.

The study period is a total of 20 weeks, comprised of an 8- week screening period and 12 weeks of treatment.

Conditions: Hypertriglyceridemia
Being tested: Omega-3-acid ethyl esters 90 (TAK-085), Eicosapentaenoic acid-ethyl (EPA-E)
Keywords: Drug Therapy
Medical subject headings: Hypertriglyceridemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Omega-3-acid ethyl esters 90 (TAK-085)Drug
Also called LOVAZA, Omacor
Omega-3-acid ethyl esters 90 (TAK-085) capsules. Each one gram of fatty acid in TAK-085 contains approximately 465 mg of EPA plus 375 mg of docosahexaenoic acid-ethyl as ethyl esters.
Eicosapentaenoic acid-ethyl (EPA-E)Drug
Also called Atheropan®
EPA-E, 0.6 g, orally, three-times daily for up to 12 weeks.

Study groups in NCT01350973
Study group	Role	What they receive
TAK-085 2 g	Experimental	TAK-085 2 g, orally, once daily for up to 12 weeks. Receives: Drug: Omega-3-acid ethyl esters 90 (TAK-085)
TAK-085 4 g	Experimental	TAK-085 2 g, orally, twice daily for up to 12 weeks. Receives: Drug: Omega-3-acid ethyl esters 90 (TAK-085)
EPA-E 1.8 g	Experimental	Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks. Receives: Drug: Eicosapentaenoic acid-ethyl (EPA-E)

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Change From Baseline in Triglyceride Level at the Final Visit
The percentage change between triglycerides collected at the end of study drug administration (the end of treatment period or discontinuation) relative to Baseline. Analysis of Covariance (ANCOVA) model was employed, using the Baseline triglyceride level as covariate and the treatment group as an independent variable.
Measured: Baseline and 12 weeks

Secondary outcomes (9)

Percent Change From Baseline in Triglyceride Level Over Time
The percentage change between triglycerides collected at each study visit relative to Baseline.
Measured: Baseline and Weeks 4, 8, 10 and 12
Percent Change From Baseline in Low-Density Lipoprotein - Cholesterol (LDL-C) Level Over Time
The percentage change between low-density lipoprotein cholesterol collected at each study visit relative to Baseline. Low-density lipoprotein cholesterol particles measured directly by nuclear magnetic resonance.
Measured: Baseline and Weeks 4, 8, 10 and 12
Percent Change From Baseline in Total Cholesterol Over Time
The percentage change between total cholesterol measured at each study visit relative to Baseline.
Measured: Baseline and Weeks 4, 8, 10 and 12
Percent Change From Baseline in High-Density Lipoprotein - Cholesterol (HDL-C) Level Over Time
The percentage change between high-density lipoprotein cholesterol collected at each study visit relative to Baseline.
Measured: Baseline and Weeks 4, 8, 10 and 12
Percent Change From Baseline in Non-High-Density Lipoprotein - Cholesterol Level Over Time
The percentage change between non-high-density lipoprotein cholesterol collected at each study visit relative to Baseline. Non-high-density lipoprotein cholesterol calculated by subtracting high-density lipoprotein cholesterol from total cholesterol.
Measured: Baseline and Weeks 4, 8, 10 and 12
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Measured: 12 Weeks
Number of Participants With TEAEs Associated With Abnormal Changes in Vital Signs
Measured: 12 Weeks
Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis
Measured: 12 Weeks
Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings After Study Drug Administration
Measured: 12 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2009Dec 2010

First posted10 May 2011 (estimated)
Study startNov 2009
Primary completionDec 2010
Study completionDec 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HypertriglyceridemiaStudies of the same condition, open and under way.
More trials run by TakedaThe 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 611 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01350973
Sponsor's protocol ID: TAK-085/CCT-002
Other IDs: JapicCTI-090937, U1111-1120-7801, JapicCTI-R140452
Status last verified: Jul 2016
First submitted: 9 May 2011
Last updated: 20 Sep 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Not yet recruitingPhase 4
Effectiveness and Tolerability of a Treat-to-Target Versus Fixed-Dose Statin Strategy in Patients With Atherosclerotic Cardiovascular Disease
Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia, Stroke (CVA) or TIA
RecruitingPhase 2
A Study of Solbinsiran (LY3561774) in Participants With Severe Hypertriglyceridemia
Severe Hypertriglyceridemia
Recruiting
Pemafibrate for Symptomatic ICAS RCT
Intracranial Atherosclerotic Disease (ICAD), Hypertriglyceridaemia
RecruitingPhase 2
A Study to Assess the Safety, Tolerability and Efficacy of ION775
Hypertriglyceridemia, Severe Hypertriglyceridemia

All Hypertriglyceridemia trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Multicenter, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of TAK-085 in Subjects With Hypertriglyceridemia.
ClinicalTrials.gov ID: NCT01350973
Acronym / sponsor ID: TAK-085/CCT-002
Conditions: Hypertriglyceridemia
Keywords: Drug Therapy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 611 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: Nov 2009
Primary completion: Dec 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 10 May 2011 (estimated)
Results: Posted 20 Sep 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This is a phase 3, double-blind, randomized study to evaluate the efficacy and safety of TAK-085 compared to EPA-E in participants with hypertriglyceridemia who are undergoing lifestyle modification.

The study period is a total of 20 weeks, comprised of an 8- week screening period and 12 weeks of treatment.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
TAK-085 2 g	Experimental	Drug: Omega-3-acid ethyl esters 90 (TAK-085)TAK-085 2 g, orally, once daily for up to 12 weeks.
TAK-085 4 g	Experimental	Drug: Omega-3-acid ethyl esters 90 (TAK-085)TAK-085 2 g, orally, twice daily for up to 12 weeks.
EPA-E 1.8 g	Experimental	Drug: Eicosapentaenoic acid-ethyl (EPA-E)Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.

Who may qualify

Ages: 20 to 74 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Participants with values of fasting triglyceride level at Visit 2 (Week -4) and Visit 3 (Week -2) are 150 mg/dL or higher and less than 750 mg/dL, and the difference between these 2 values is within 30% of the higher one.
Participants with differences between 2 values of fasting Low density lipoprotein - cholesterol level measured at Visit 2 (Week -4) and Visit 3 (Week -2) are within 25% of the higher one.

Key exclusion criteria (6 listed)

Participants who have coronary artery diseases (eg, confirmed myocardial infarction and angina pectoris) within 6 months prior to Visit 1 (Week -8) or participants with a history of revascularization.
Participants who received aortic aneurysmectomy or is complicated with aortic aneurysm within 6 months prior to Visit 1 (Week -8).
Participants who have a history or complication of a clinically significant hemorrhagic disease (eg, hemophilia, capillary fragility illness, digestive tract ulcer, urinary tract hemorrhage, hemoptysis, vitreous haemorrhage and so forth) within 6 months prior to Visit 1 (Week -8).
Participants who have been diagnosed with pancreatitis.
Participants who have been diagnosed with lipoprotein lipase (LPL) deficiency, apolipoprotein C-II deficiency or type III familial hyperlipidemia.

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
Omega-3-acid ethyl esters 90 (TAK-085)Also: LOVAZA, OmacorOmega-3-acid ethyl esters 90 (TAK-085) capsules. Each one gram of fatty acid in TAK-085 contains approximately 465 mg of EPA plus 375 mg of docosahexaenoic acid-ethyl as ethyl esters.	Drug	TAK-085 2 g, TAK-085 4 g
Eicosapentaenoic acid-ethyl (EPA-E)Also: Atheropan®EPA-E, 0.6 g, orally, three-times daily for up to 12 weeks.	Drug	EPA-E 1.8 g

Primary outcome

Percent Change From Baseline in Triglyceride Level at the Final Visit
Time frame: Baseline and 12 weeks
The percentage change between triglycerides collected at the end of study drug administration (the end of treatment period or discontinuation) relative to Baseline. Analysis of Covariance (ANCOVA) model was employed, using the Baseline triglyceride level as covariate and the treatment group as an independent variable.

9 secondary outcomes

Percent Change From Baseline in Triglyceride Level Over Time
Time frame: Baseline and Weeks 4, 8, 10 and 12
Percent Change From Baseline in Low-Density Lipoprotein - Cholesterol (LDL-C) Level Over Time
Time frame: Baseline and Weeks 4, 8, 10 and 12
Percent Change From Baseline in Total Cholesterol Over Time
Time frame: Baseline and Weeks 4, 8, 10 and 12
Percent Change From Baseline in High-Density Lipoprotein - Cholesterol (HDL-C) Level Over Time
Time frame: Baseline and Weeks 4, 8, 10 and 12
Percent Change From Baseline in Non-High-Density Lipoprotein - Cholesterol Level Over Time
Time frame: Baseline and Weeks 4, 8, 10 and 12
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: 12 Weeks
Number of Participants With TEAEs Associated With Abnormal Changes in Vital Signs
Time frame: 12 Weeks
Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis
Time frame: 12 Weeks
Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings After Study Drug Administration
Time frame: 12 Weeks

Results and safety

Results posted to the registry on 20 Sep 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TAK-085 2 g	206	200
TAK-085 4 g	210	202
EPA-E 1.8 g	195	187

Primary outcome: Percent Change From Baseline in Triglyceride Level at the Final Visit

Time frame: Baseline and 12 weeks. Least squares mean (Standard Error). Unit: percent change

Measure	TAK-085 2 g n = 203	TAK-085 4 g n = 208	EPA-E 1.8 g n = 194
Value	-10.93 (1.6434)	-22.65 (1.6238)	-11.30 (1.6807)

TAK-085 2 g vs EPA-E 1.8 g: LS Mean Difference: 0.37 (95% CI -4.2491 to 4.9830), p = 0.8760, ANCOVA
TAK-085 4 g vs EPA-E 1.8 g: LS Mean Difference: -11.35 (95% CI -15.9442 to -6.7637), p < 0.0001, ANCOVA

Population analysed: Full analysis set including all participants who were randomized and received at least one dose of the investigational product and with available data.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Collection of AEs commenced from the time that the subject was first administered investigational product (Week 0). Routine collection of AEs continued until the completion of study treatment (12 weeks of administration). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TAK-085 2 g	1 of 205 (0.5%)	22 of 205 (10.7%)	Not reported
TAK-085 4 g	4 of 210 (1.9%)	9 of 210 (4.3%)	Not reported
EPA-E 1.8 g	2 of 195 (1%)	20 of 195 (10.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hypertriglyceridemia

Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Not yet recruitingPhase 4
Effectiveness and Tolerability of a Treat-to-Target Versus Fixed-Dose Statin Strategy in Patients With Atherosclerotic Cardiovascular Disease
Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia, Stroke (CVA) or TIA
RecruitingPhase 2
A Study of Solbinsiran (LY3561774) in Participants With Severe Hypertriglyceridemia
Severe Hypertriglyceridemia
Recruiting
Pemafibrate for Symptomatic ICAS RCT
Intracranial Atherosclerotic Disease (ICAD), Hypertriglyceridaemia
RecruitingPhase 2
A Study to Assess the Safety, Tolerability and Efficacy of ION775
Hypertriglyceridemia, Severe Hypertriglyceridemia

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.

Associate Professor, Clinical Cell Biology and Medicine study director

Graduate School of Medicine, Chiba University

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Omega-3-acid ethyl esters 90 (TAK-085) and Eicosapentaenoic acid-ethyl (EPA-E) in people with Hypertriglyceridemia, run by Takeda.

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 2 inclusion and 6 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 20 Sep 2016. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percent Change From Baseline in Triglyceride Level at the Final Visit (time frame: Baseline and 12 weeks). 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 NCT01350973.

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 20 Sep 2016.