HypertriglyceridemiaPhase 3NCT01725646
An Efficacy and Safety Study of Omacor® in Taiwanese Hypertriglyceridemic Patients
A Phase 3 study testing Omacor® in people with Hypertriglyceridemia, run by Excelsior at 4 sites in Taiwan.
Trial summary
1. Evaluation of the efficacy of Omacor® in Taiwanese hypertriglyceridemia patients 2. Evaluation of the safety of Omacor® in Taiwanese hypertriglyceridemia patients Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Hypertriglyceridemia
- What is being tested?
- Omacor®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 253 participants
- Where
- 4 sitesTaiwan
- Study dates
- Jul 2011to Aug 2013
- 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 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has fasting serum TG ≥ 200 mg/dL but no more than 1000 mg/dL
Who cannot join
- Patients had a history of pancreatitis or considered to be at risk of developing pancreatitis
- Patient had history of a severe cardiovascular event or a revascularization procedure within 6 months prior to randomization
Trial locations and contacts
4 sites in 1 country.
Taiwan4 sites
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
National Cheng Kung University Hospital
Tainan, Taiwan, 704
National Taiwan University Hospital
Taipei, Taiwan, 100
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
About this study
Official title: A Randomized, Double-blinded, Placebo-controlled Study to Assess the Efficacy and Safety of Omacor® in Taiwanese Hypertriglyceridemic Patients
- Evaluation of the efficacy of Omacor® in Taiwanese hypertriglyceridemia patients
- Evaluation of the safety of Omacor® in Taiwanese hypertriglyceridemia patients
Read the detailed description
The primary end point is to evaluate the efficacy and safety of Omacor in Taiwanese hypertriglyceridemia patients.
- Conditions
- Hypertriglyceridemia
- Being tested
- Omacor®, Placebo
- Keywords
- Hypertriglyceridemia, omega-3-acid ethyl ester
- Medical subject headings
- Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omacor®Drug
Also called Omega-3-acid ethyl ester 90
Subjects in 4 g and 2 g Omacor® will take this drug
PlaceboDrug
Also called Olive oil
Subjects in placebo group will take this drug
| Study group | Role | What they receive |
|---|---|---|
| Omacor® 4 g | Active comparator | Subjects in this group will take 4 g of Omacor® everyday. Receives: Drug: Omacor® |
| Omacor® 2 g | Active comparator | Subjects in this group will take 2 g of Omacor® and 2 g of placebo everyday. Receives: Drug: Omacor® |
| Placebo | Placebo comparator | Subjects in this group will take 4 g of placebo everyday. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Triglycerides from baseline
Measured: baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2012 (estimated)
- Study startJul 2011
- Primary completionJul 2013
- Study completionAug 2013
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- Excelsior
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chuen-Den Tseng, M.D., PhD., Principal investigator, NTUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01725646
- Sponsor's protocol ID
- OM3-99001
- Status last verified
- May 2014
- First submitted
- 29 Oct 2012
- Last updated
- 19 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded, Placebo-controlled Study to Assess the Efficacy and Safety of Omacor® in Taiwanese Hypertriglyceridemic Patients
- ClinicalTrials.gov ID
- NCT01725646
- Acronym / sponsor ID
- OM3-99001
- Conditions
- Hypertriglyceridemia
- Keywords
- Hypertriglyceridemia, omega-3-acid ethyl ester
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- ExcelsiorIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 14 Nov 2012 (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.
- Evaluation of the efficacy of Omacor® in Taiwanese hypertriglyceridemia patients
- Evaluation of the safety of Omacor® in Taiwanese hypertriglyceridemia patients
Detailed description
The primary end point is to evaluate the efficacy and safety of Omacor in Taiwanese hypertriglyceridemia patients.
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 |
|---|---|---|
| Omacor® 4 g | Active comparator | Drug: Omacor®Subjects in this group will take 4 g of Omacor® everyday. |
| Omacor® 2 g | Active comparator | Drug: Omacor®Subjects in this group will take 2 g of Omacor® and 2 g of placebo everyday. |
| Placebo | Placebo comparator | Drug: PlaceboSubjects in this group will take 4 g of placebo everyday. |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient has fasting serum TG ≥ 200 mg/dL but no more than 1000 mg/dL
Key exclusion criteria (2 listed)
- Patients had a history of pancreatitis or considered to be at risk of developing pancreatitis
- Patient had history of a severe cardiovascular event or a revascularization procedure within 6 months prior to randomization
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 |
|---|---|---|
| Omacor®Also: Omega-3-acid ethyl ester 90Subjects in 4 g and 2 g Omacor® will take this drug | Drug | Omacor® 2 g, Omacor® 4 g |
| PlaceboAlso: Olive oilSubjects in placebo group will take this drug | Drug | Placebo |
Primary outcome
Change in Triglycerides from baseline
Time frame: baseline and 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 19 May 2014.
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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.
Chuen-Den Tseng, M.D., PhD. principal investigator
NTUH
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Omacor® in people with Hypertriglyceridemia, run by Excelsior at 4 sites in Taiwan.
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 1 inclusion and 2 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 19 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change in Triglycerides from baseline (time frame: baseline and 8 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 19 May 2014.