HypertriglyceridemiaPhase 3NCT04756180
An Efficacy and Safety Study of Omega-3-acid Ethyl Ester in Chinese Subjects With Hypertriglyceridemia.
A Phase 3 study of Hypertriglyceridemia, run by Abbott.
Trial summary
The primary objective was to investigate the effect of 12-week treatment of Omacor on fasting serum triglycerides (TG) in Chinese subjects with hypertriglyceridemia (HTG). The secondary objectives were to investigate the safety and tolerability and effect of Omacor on lipid parameters after 12 weeks treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypertriglyceridemia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 248 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Apr 2019
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Baseline fasting serum TG level > 200mg/dL and <1000mg/dL, in subjects treated for HTG.
- If on previous statin therapy, the treatment should have been kept stable in the last 3 months before entering the study.
- Able and willing to give written informed consent.
Who cannot join
- Subjects taking fish oil capsules 8 weeks prior to inclusion in this study.
- Known allergy to the active ingredient, or fish, soya, corn or olive oild (placebos).
- Pregnant of lactating females.
- Known increased risk of hemorrhage such as recent surgery, gastrointestinal hemorrhagic disease.
- Significant hepatic disease.
- Significantly reduced renal function.
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- Alcohol consumption >30g for male and 20g for female daily.
- Concomitant use of other investigational drugs.
- Subject related to the investigator.
- Subject expected to be not compliant.
About this study
Official title: A Placebo-Controlled, Multicenter, Randomized, Double-Blind, Parallel Group Study to Investigate the Efficacy and Safety of Omega-3-acid Ethyl Ester Over 12 Weeks in Chinese Subjects With Hypertriglyceridemia
The primary objective was to investigate the effect of 12-week treatment of Omacor on fasting serum triglycerides (TG) in Chinese subjects with hypertriglyceridemia (HTG). The secondary objectives were to investigate the safety and tolerability and effect of Omacor on lipid parameters after 12 weeks treatment.
Read the detailed description
This was a multicenter, randomized, double-blind, parallel-group study of twice daily treatment of Omacor or matching placebo in subjects with moderate or severe HTG.
- Conditions
- Hypertriglyceridemia
- Being tested
- Omega-3-acid ethyl ester or Placebo
- 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 ester or PlaceboDrug
Omega-3-acid ethyl ester 2 gm/day for first 4 week followed by 4gm/day for 8 week
| Study group | Role | What they receive |
|---|---|---|
| Omacor | Experimental | Omacor 2gm/day for first 4 week followed by 4gms/day for 8 weeks Receives: Drug: Omega-3-acid ethyl ester or Placebo |
| Placebo | Placebo comparator | Omacor Placebo 2gm/day for first 4 week followed by 4gms/day for 8 weeks Receives: Drug: Omega-3-acid ethyl ester or Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in fasting serum TG
Percent change from baseline in fasting serum TG
Measured: Baseline to end of treatment at treatment week 12
Secondary outcomes (1)
Change in total cholesterol, LDL-cholesterol, HDL cholesterol, non-HDL-cholesterol and the LDL/HDL ratio
Change from baseline in total cholesterol, LDL-cholesterol, HDL cholesterol, non-HDL-cholesterol and the LDL/HDL ratio
Measured: Between baseline and end of treatment week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study startOct 2016
- Primary completionApr 2019
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertriglyceridemiaStudies of the same condition, open and under way.
- 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
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pooi Lee Chin, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04756180
- Sponsor's protocol ID
- PUFA3001
- Status last verified
- Mar 2021
- First submitted
- 12 Jan 2021
- Last updated
- 5 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-Controlled, Multicenter, Randomized, Double-Blind, Parallel Group Study to Investigate the Efficacy and Safety of Omega-3-acid Ethyl Ester Over 12 Weeks in Chinese Subjects With Hypertriglyceridemia
- ClinicalTrials.gov ID
- NCT04756180
- Acronym / sponsor ID
- PUFA3001
- Conditions
- Hypertriglyceridemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Oct 2016 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 16 Feb 2021 (actual)
- 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 primary objective was to investigate the effect of 12-week treatment of Omacor on fasting serum triglycerides (TG) in Chinese subjects with hypertriglyceridemia (HTG). The secondary objectives were to investigate the safety and tolerability and effect of Omacor on lipid parameters after 12 weeks treatment.
Detailed description
This was a multicenter, randomized, double-blind, parallel-group study of twice daily treatment of Omacor or matching placebo in subjects with moderate or severe HTG.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omacor | Experimental | Drug: Omega-3-acid ethyl ester or PlaceboOmacor 2gm/day for first 4 week followed by 4gms/day for 8 weeks |
| Placebo | Placebo comparator | Drug: Omega-3-acid ethyl ester or PlaceboOmacor Placebo 2gm/day for first 4 week followed by 4gms/day for 8 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Baseline fasting serum TG level > 200mg/dL and <1000mg/dL, in subjects treated for HTG.
- If on previous statin therapy, the treatment should have been kept stable in the last 3 months before entering the study.
- Able and willing to give written informed consent.
Key exclusion criteria (10 listed)
- Subjects taking fish oil capsules 8 weeks prior to inclusion in this study.
- Known allergy to the active ingredient, or fish, soya, corn or olive oild (placebos).
- Pregnant of lactating females.
- Known increased risk of hemorrhage such as recent surgery, gastrointestinal hemorrhagic disease.
- Significant hepatic disease.
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 ester or PlaceboOmega-3-acid ethyl ester 2 gm/day for first 4 week followed by 4gm/day for 8 week | Drug | Omacor, Placebo |
Primary outcome
Percent change in fasting serum TG
Time frame: Baseline to end of treatment at treatment week 12
Percent change from baseline in fasting serum TG
1 secondary outcome
Change in total cholesterol, LDL-cholesterol, HDL cholesterol, non-HDL-cholesterol and the LDL/HDL ratio
Time frame: Between baseline and end of treatment week 12
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 5 Mar 2021.
- Individual participant dataSharing planned: No
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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.
Pooi Lee Chin study director
Abbott
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Hypertriglyceridemia, run by Abbott.
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 3 inclusion and 10 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 5 Mar 2021. 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. Some participants in this study may receive a placebo. 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?
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?
Percent change in fasting serum TG (time frame: Baseline to end of treatment at treatment week 12). 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 5 Mar 2021.