HypertriglyceridemiaPhase 3OMEELVHTNCT02625870
Omega-3-Acid Ethyl Esters 90 Soft Capsules for Lowering Very High Triglycerides
A Phase 3 study testing Omega-3-Acid Ethyl Esters 90 Soft Capsules and Corn Oil in people with Hypertriglyceridemia, run by Jiangsu HengRui Medicine Co., Ltd..
Trial summary
The trial was a double-blind, randomized, parallel-group study comparing Omega-3-Acid Ethyl Esters 90 Soft Capsules and placebo. The primary objective of the present study was to evaluate the efficacy and safety of Omega-3-Acid Ethyl Esters 90 Soft Capsules in subjects with severe hypertriglyceridemia (TGs ≥500 mg/dL… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertriglyceridemia
- What is being tested?
- Omega-3-Acid Ethyl Esters 90 Soft Capsules and Corn Oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Dec 2016
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -1.At least 2 times of fasting serum TG concentrations≥500 mg/dL but<2000 mg/dL at screening (2and 1 and 0 weeks before random assignment).
- 2.Two times qualified High Triglycerides Dietary Assessment Table at 2 and 0 weeks before random assignment according to the "prevention and treatment of dyslipidemia in Chinese adults Guide ".
Who cannot join
- 1.Unable to discontinue use of other omega-3 fatty acid-containing products, bile acid sequestrants, fibrates ,niacin or any supplement used to alter lipid metabolism throughout the entire study.
- 2.Patients taking bile acid sequestrants, fibrate, niacin or any supplement used to alter lipid metabolism more than 6 weeks before entering the study dietary phase.
- 3.Subjects consuming omega-3 fatty acid-containing products such as cod liver oil, or lipid-decreasing fibers at least 4 weeks before beginning the study.
- 4.Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST)>3 times the upper limit of normal.
- 5.Serum creatinine >176μmol/L. 6.Platelet counts<60×109/L，hemoglobin <100 g/L. 7.Poorly controlled hypertension(resting blood pressure ≥160 mm Hg systolic or ≥100 mm Hg diastolic) 8.Uncontrolled type II diabetes(fasting blood sugar >11.1mmol/L). 9.Type II diabetes, nephrotic syndrome, hypothyroidism. 10.Atrial fibrillation. 11.History of pancreatitis and symptomatic gallstone disease, unless treated with cholecystectomy.
- 12.History of cancer (other than basal cell carcinoma) in the past 2 years. 13.Allergy or intolerance to omega-3 fatty acids, omega-3-acid ethyl esters, or fish.
- 14.History in the past 12 months of drug abuse or alcohol abuse (.14 drinks per week; 1 drink was equivalent to 12 oz beer, 5 oz wine, or 1.5 oz hard liquor) was also exclusionary.
- 15.Exposure to any investigational product, within 30 days prior to Visit. 16.Presence of any other condition the Investigator believes would interfere the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A 12-Week, Randomized, Double-Blind, Corn Oil-Controlled Phase 3 Study to Assess the Efficacy and Safety of Omega-3-Acid Ethyl Esters 90 Soft Capsules in Subjects With Severe Hypertriglyceridemia
The trial was a double-blind, randomized, parallel-group study comparing Omega-3-Acid Ethyl Esters 90 Soft Capsules and placebo. The primary objective of the present study was to evaluate the efficacy and safety of Omega-3-Acid Ethyl Esters 90 Soft Capsules in subjects with severe hypertriglyceridemia (TGs ≥500 mg/dL but <2000 mg/dL).
- Conditions
- Hypertriglyceridemia
- Being tested
- Omega-3-Acid Ethyl Esters 90 Soft Capsules, Corn Oil
- 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 Soft CapsulesDrug
Omega-3-Acid Ethyl Esters 90 Soft Capsules will be provided in 1 g polyacrylate-coated soft gel capsules.Four capsules will be taken with breakfast once per day, for 12 weeks.
Corn OilDrug
Corn Oil will be provided in 1 g polyacrylate-coated soft gel capsules.Four capsules will be taken with breakfast once per day, for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Omega-3-Acid Ethyl Esters 90 Soft Capsules | Experimental | Not described Receives: Drug: Omega-3-Acid Ethyl Esters 90 Soft Capsules |
| Corn Oil | Placebo comparator | Not described Receives: Drug: Corn Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
End-of-treatment Serum Triglycerides percentage change from baseline under fasting conditions
Measured: 12 weeks
Secondary outcomes (8)
End-of-treatment non-HDL-C percentage change from baseline under fasting conditions
Measured: 12 weeks
End-of-treatment TC percentage change from baseline under fasting conditions
Measured: 12 weeks
End-of-treatment VLDL-C percentage change from baseline under fasting conditions
Measured: 12 weeks
End-of-treatment HDL-C percentage change from baseline under fasting conditions
Measured: 12 weeks
End-of-treatment LDL-C percentage change from baseline under fasting conditions
Measured: 12 weeks
End-of-treatment LDL-C/HDL-C percentage change from baseline under fasting conditions
Measured: 12 weeks
End-of-treatment Apo A5 percentage change from baseline under fasting conditions
Measured: 12 weeks
End-of-treatment Apo C3 percentage change from baseline under fasting conditions
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionDec 2016 (estimated)
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.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02625870
- Sponsor's protocol ID
- HROMEE2015
- Acronym
- OMEELVHT
- Status last verified
- Dec 2015
- First submitted
- 7 Dec 2015
- Last updated
- 9 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-Week, Randomized, Double-Blind, Corn Oil-Controlled Phase 3 Study to Assess the Efficacy and Safety of Omega-3-Acid Ethyl Esters 90 Soft Capsules in Subjects With Severe Hypertriglyceridemia
- ClinicalTrials.gov ID
- NCT02625870
- Acronym / sponsor ID
- OMEELVHT / HROMEE2015
- Conditions
- Hypertriglyceridemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Dec 2016 (estimated)
- First posted
- 9 Dec 2015 (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 trial was a double-blind, randomized, parallel-group study comparing Omega-3-Acid Ethyl Esters 90 Soft Capsules and placebo. The primary objective of the present study was to evaluate the efficacy and safety of Omega-3-Acid Ethyl Esters 90 Soft Capsules in subjects with severe hypertriglyceridemia (TGs ≥500 mg/dL but <2000 mg/dL).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega-3-Acid Ethyl Esters 90 Soft Capsules | Experimental | Drug: Omega-3-Acid Ethyl Esters 90 Soft Capsules |
| Corn Oil | Placebo comparator | Drug: Corn Oil |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- -1.At least 2 times of fasting serum TG concentrations≥500 mg/dL but<2000 mg/dL at screening (2and 1 and 0 weeks before random assignment).
- 2.Two times qualified High Triglycerides Dietary Assessment Table at 2 and 0 weeks before random assignment according to the "prevention and treatment of dyslipidemia in Chinese adults Guide ".
Key exclusion criteria (8 listed)
- 1.Unable to discontinue use of other omega-3 fatty acid-containing products, bile acid sequestrants, fibrates ,niacin or any supplement used to alter lipid metabolism throughout the entire study.
- 2.Patients taking bile acid sequestrants, fibrate, niacin or any supplement used to alter lipid metabolism more than 6 weeks before entering the study dietary phase.
- 3.Subjects consuming omega-3 fatty acid-containing products such as cod liver oil, or lipid-decreasing fibers at least 4 weeks before beginning the study.
- 4.Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST)>3 times the upper limit of normal.
- 5.Serum creatinine >176μmol/L. 6.Platelet counts<60×109/L，hemoglobin <100 g/L. 7.Poorly controlled hypertension(resting blood pressure ≥160 mm Hg systolic or ≥100 mm Hg diastolic) 8.Uncontrolled type II diabetes(fasting blood sugar >11.1mmol/L). 9.Type II diabetes, nephrotic syndrome, hypothyroidism. 10.Atrial fibrillation. 11.History of pancreatitis and symptomatic gallstone disease, unless treated with cholecystectomy.
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 Soft CapsulesOmega-3-Acid Ethyl Esters 90 Soft Capsules will be provided in 1 g polyacrylate-coated soft gel capsules.Four capsules will be taken with breakfast once per day, for 12 weeks. | Drug | Omega-3-Acid Ethyl Esters 90 Soft Capsules |
| Corn OilCorn Oil will be provided in 1 g polyacrylate-coated soft gel capsules.Four capsules will be taken with breakfast once per day, for 12 weeks. | Drug | Corn Oil |
Primary outcome
End-of-treatment Serum Triglycerides percentage change from baseline under fasting conditions
Time frame: 12 weeks
8 secondary outcomes
End-of-treatment non-HDL-C percentage change from baseline under fasting conditions
Time frame: 12 weeks
End-of-treatment TC percentage change from baseline under fasting conditions
Time frame: 12 weeks
End-of-treatment VLDL-C percentage change from baseline under fasting conditions
Time frame: 12 weeks
End-of-treatment HDL-C percentage change from baseline under fasting conditions
Time frame: 12 weeks
End-of-treatment LDL-C percentage change from baseline under fasting conditions
Time frame: 12 weeks
End-of-treatment LDL-C/HDL-C percentage change from baseline under fasting conditions
Time frame: 12 weeks
End-of-treatment Apo A5 percentage change from baseline under fasting conditions
Time frame: 12 weeks
End-of-treatment Apo C3 percentage change from baseline under fasting conditions
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2015.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Omega-3-Acid Ethyl Esters 90 Soft Capsules and Corn Oil in people with Hypertriglyceridemia, run by Jiangsu HengRui Medicine Co., Ltd..
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 8 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: status not confirmed, as of the sponsor's last update on 9 Dec 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liang Ni, Graduate (18036618765, niliang@hrs.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
End-of-treatment Serum Triglycerides percentage change from baseline under fasting conditions (time frame: 12 weeks). 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 9 Dec 2015.