HypertriglyceridemiaPhase 3NCT01350999
Long-term Efficacy and Safety Study 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) in people with Hypertriglyceridemia, run by Takeda.
Trial summary
The purpose of this study is to determine the safety and efficacy 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)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 503 participants
- Where
- No sites listed yet
- Study dates
- Nov 2009to Jan 2011
- 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
- Visit 1 (Week -4)
- Undergoing lifestyle modification.
- Triglyceride (TG) level (fasting state) 150 mg/dL or higher and less than 750 mg/dL at Visit 1 (Week -4).
- Both genders, aged from 20 to less than 75 years at the time of signing informed consent.
- Outpatient.
- Capable of understanding and complying with protocol requirements.
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- Signed a written, informed consent form prior to the initiation of any study procedures.
- A female with childbearing potential (premenopausal and non-sterilized) must have agreed to use routinely adequate contraception from signing of informed consent throughout the duration of the study.
- Visit 2 (Week -2)
- Fasting TG level 150 mg/dL or higher and less than 750 mg/dL at Visit 2 (Week -2).
- Difference in fasting low density lipoprotein-cholesterol (LDL-C) level between Visit 1 (Week -4) and Visit 2 (Week -2) within 25% of the higher value
Who cannot join
- Visit 1 (Week -4)
- Any coronary artery diseases (CAD, e.g., confirmed myocardial infarction and angina pectoris) within 6 months prior to Visit 1 (Week -4) or a history of revascularization.
- Received aortic aneurysmectomy or had had aortic aneurysm within 6 months prior to Visit 1 (Week -4).
- History or complication of a clinically significant hemorrhagic disease (e.g., hemophilia, capillary fragility illness, digestive tract ulcer, urinary tract haemorrhage, hemoptysis, vitreous haemorrhage) within 6 months prior to Visit 1 (Week -4).
- Diagnosed with pancreatitis.
- Diagnosed with lipoprotein lipase (LPL) deficiency, apolipoprotein C-II deficiency or type III familial hyperlipidemia.
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- Cushing's syndrome, uremia, systemic lupus erythematosus (SLE) or serum dysproteinemia.
- Type 1 diabetes mellitus or with uncontrolled type 2 diabetes mellitus defined by glycosylated hemoglobin (HbA1C) level of 8.0% or higher at Visit 1 (Week -4).
- Stage III hypertension defined by systolic blood pressure of 180 mmHg or higher or diastolic blood pressure of 110 mmHg or higher regardless of the use of antihypertensive medication.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level at Visit 1 (Week -4) was not less than twice the upper limit of the normal reference range.
- If female, was pregnant or lactating.
- Habitual drinking defined by an average daily alcohol intake of 100 mL or more , drug abuse or drug dependency, or a history of any of these conditions.
- Started to take any antihyperlipidemic drugs within 4 weeks prior to Visit 1 (Week -4).
- Received any investigational products (including those for post-marketing clinical study) within 12 weeks prior to Visit 1 (Week -4).
- Received TAK-085 in a clinical study.
- Judged as being ineligible for study participation by the investigator or subinvestigator for any other reasons.
- Visit 2 (Week -2)
- ALT or AST level at Visit 2 (Week -2) was twice the upper limit of the normal reference range or higher.
- Needed a change in the dose of antihyperlipidemic drugs or antidiabetic drugs, addition of a new drug or a change in the type of the drugs during the screening period.
- Judged as being ineligible for study participation by the investigator or subinvestigator for any other reasons.
- Visit 3 (Week 0)
- Needed a change in the dose of antihyperlipidemic drugs or antidiabetic drugs, addition of a new drug or a change in the type of the drugs during the screening period.
- Judged as being ineligible for study participation by the investigator or subinvestigator for any other reasons
About this study
Official title: A Phase 3 Long-term Study of TAK-085 in Subjects With Hypertriglyceridemia
The purpose of this study is to determine the safety and efficacy 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 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, open-label, randomized study to evaluate the efficacy and safety of TAK-085. In addition, EPA-E is also administered for 52 weeks for reference to evaluate the safety of TAK-085 in participants with hypertriglyceridemia who are undergoing lifestyle modification.
The study period is a total of 56 weeks, comprised of a 4- week screening period and 52 weeks of treatment.
- Conditions
- Hypertriglyceridemia
- Being tested
- omega-3-acid ethyl esters 90 (TAK-085), Eicosapentaenoic acid-ethyl (EPA)
- 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)Drug
EPA-E capsules
| Study group | Role | What they receive |
|---|---|---|
| TAK-085 2 g | Experimental | TAK-085 2 g, orally, once daily for up to 52 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 52 weeks. Receives: Drug: omega-3-acid ethyl esters 90 (TAK-085) |
| EPA-E 1.8 g | Active comparator | Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks. Receives: Drug: Eicosapentaenoic acid-ethyl (EPA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Measured: 52 Weeks
Number of Participants With TEAEs Associated With Abnormal Changes in Vital Signs
Measured: 52 Weeks
Number of Participants With TEAEs Associated With Abnormal Changes in Body Weight
Measured: 52 Weeks
Number of Participants With Clinically Significant Findings in Electrocardiogram After Study Drug Administration
Participants whose results of electrocardiograms were judged as abnormal and clinically significant by investigator after study drug administration were counted in this measure.
Measured: 52 Weeks
Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis
Measured: 52 Weeks
Secondary outcomes (5)
Percent Change From Baseline in Triglyceride Level
Measured: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Percent Change From Baseline in Low-Density Lipoprotein - Cholesterol (LDL-C)
Measured: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Percent Change From Baseline in Total Cholesterol
Measured: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Percent Change From Baseline in High-Density Lipoprotein - Cholesterol (HDL-C)
Measured: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Percent Change From Baseline in Non-High-Density Lipoprotein - Cholesterol
Non-high-density lipoprotein cholesterol was calculated by subtracting high-density lipoprotein cholesterol from total cholesterol.
Measured: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2011 (estimated)
- Study startNov 2009
- Primary completionJan 2011
- Study completionJan 2011
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
- None (open label)
- Enrolment
- 503 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Associate Professor, Clinical Cell Biology and Medicine, Study director, Graduate School of Medicine, Chiba University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01350999
- Sponsor's protocol ID
- TAK-085/OCT-001
- Other IDs
- JapicCTI-090936, U1111-1120-7892, JapicCTI-R140451
- 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
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 Long-term Study of TAK-085 in Subjects With Hypertriglyceridemia
- ClinicalTrials.gov ID
- NCT01350999
- Acronym / sponsor ID
- TAK-085/OCT-001
- Conditions
- Hypertriglyceridemia
- Keywords
- Drug Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 503 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (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.
The purpose of this study is to determine the safety and efficacy 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.
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, open-label, randomized study to evaluate the efficacy and safety of TAK-085. In addition, EPA-E is also administered for 52 weeks for reference to evaluate the safety of TAK-085 in participants with hypertriglyceridemia who are undergoing lifestyle modification.
The study period is a total of 56 weeks, comprised of a 4- week screening period and 52 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- 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 52 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 52 weeks. |
| EPA-E 1.8 g | Active comparator | Drug: Eicosapentaenoic acid-ethyl (EPA)Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks. |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Visit 1 (Week -4)
- Undergoing lifestyle modification.
- Triglyceride (TG) level (fasting state) 150 mg/dL or higher and less than 750 mg/dL at Visit 1 (Week -4).
- Both genders, aged from 20 to less than 75 years at the time of signing informed consent.
- Outpatient.
Key exclusion criteria (23 listed)
- Visit 1 (Week -4)
- Any coronary artery diseases (CAD, e.g., confirmed myocardial infarction and angina pectoris) within 6 months prior to Visit 1 (Week -4) or a history of revascularization.
- Received aortic aneurysmectomy or had had aortic aneurysm within 6 months prior to Visit 1 (Week -4).
- History or complication of a clinically significant hemorrhagic disease (e.g., hemophilia, capillary fragility illness, digestive tract ulcer, urinary tract haemorrhage, hemoptysis, vitreous haemorrhage) within 6 months prior to Visit 1 (Week -4).
- Diagnosed with pancreatitis.
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)EPA-E capsules | Drug | EPA-E 1.8 g |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: 52 Weeks
Number of Participants With TEAEs Associated With Abnormal Changes in Vital Signs
Time frame: 52 Weeks
Number of Participants With TEAEs Associated With Abnormal Changes in Body Weight
Time frame: 52 Weeks
Number of Participants With Clinically Significant Findings in Electrocardiogram After Study Drug Administration
Time frame: 52 Weeks
Participants whose results of electrocardiograms were judged as abnormal and clinically significant by investigator after study drug administration were counted in this measure.
Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis
Time frame: 52 Weeks
5 secondary outcomes
Percent Change From Baseline in Triglyceride Level
Time frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Percent Change From Baseline in Low-Density Lipoprotein - Cholesterol (LDL-C)
Time frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Percent Change From Baseline in Total Cholesterol
Time frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Percent Change From Baseline in High-Density Lipoprotein - Cholesterol (HDL-C)
Time frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Percent Change From Baseline in Non-High-Density Lipoprotein - Cholesterol
Time frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Results and safety
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.
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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.
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) 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 11 inclusion and 23 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?
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (time frame: 52 Weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.