Hyperlipidemia, Familial CombinedPhase 3NCT02035215
Phase 3 Study to Evaluate the Efficacy and Safety of Omega-3-acids Ethylesters 90 in Type Ⅱb Hyperlipidemia
A Phase 3 study testing Atorvastatin 20mg and Omega-3-acids ethylesters 90 4g in people with Hyperlipidemia, Familial Combined, run by Kuhnil Pharmaceutical Co., Ltd. at 4 sites in South Korea.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of combination therapy of omega-3-acids ethylesters 90/Atorvastatin calcium in type Ⅱb hyperlipidemia Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Hyperlipidemia, Familial Combined
- What is being tested?
- Atorvastatin 20mg and Omega-3-acids ethylesters 90 4g
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 4 sitesSouth Korea
- Study dates
- Jan 2014to Dec 2014
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- LDL≥160mg/dl, 200mg/dl≤TG<500mg/dl
- In the case of smokers, he agrees should be smoke-free
- In the case of women of childbearing age, urine pregnancy test must be negative
Who cannot join
- Patients with acute artery disease within 3 months
- History of revascularization procedure or aneurism operation within 6months
- Patients with myopathy, rhabdomyolysis
- Patients with pancreatitis
- Patients with HIV positive
- History of malignant tumor within 2 years
Show all 18Show fewer
- Patients must be treated with medications prohibited for concomitant use during study period
- Patients with uncontrolled hypertension(SBP>180mmHg or DBP>110mmHg)
- Serum Creatinine>1.2mg/dl(female), >1.4mg/dl(male)
- AST or ALT > 2X ULN
- CPK > 2X ULN
- Patients with galactose intolerance or Lapp lactase deficiency, glucose-galactose malabsorption
- Allergy or Hypersensitive to investigational drug
- History of drug or alcohol abuse within 2 years
- In the case of smokers, who do not intend to non smoking
- Women with pregnant, breast-feeding
- Patients treated with any investigational drugs within 1 month at the time consents are obtained
- Not eligible to participate for the study at the discretion of investigator
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites, 2 recruiting
- Active, not recruiting
Hallym University Sacred Heart Hospital
Anyang, Gyeonggi, 431-070
- Not yet recruiting
Gachon University Gil Hospital
Incheon, 405-760
- Recruiting
Korea University Guro Hospital
Seoul, 152-703
- Active, not recruiting
Uijongbu St. Mary's Hospital
Uijongbu, Gyeonggi, 480-717
About this study
Official title: Efficacy and Safety of Co-administration of Omacor Plus Atorvastatin Compared With Atorvastatin Monotherapy in Patients With Type Ⅱb Dyslipidemia: a Multicenter, Double-blind, Randomized, Active-controlled, Parallel, Phase Ⅲ Study
The purpose of this study is to evaluate the efficacy and safety of combination therapy of omega-3-acids ethylesters 90/Atorvastatin calcium in type Ⅱb hyperlipidemia
- Conditions
- Hyperlipidemia, Familial Combined
- Being tested
- Atorvastatin 20mg, Omega-3-acids ethylesters 90 4g, Placebo(Omega-3-acids ethylesters 90)
- Keywords
- Hyperlipidemia, Familial Combined, Omega 3 acids ethylesters 90, Atorvastatin
- Medical subject headings
- Hyperlipidemia, Familial Combined
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin 20mgDrug
Also called Lipitor 20mg
Omega-3-acids ethylesters 90 4gDrug
Also called Omacor Soft Capsule 4g
Placebo(Omega-3-acids ethylesters 90)Other
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin 20mg, Omega-3-acids ethylesters 90 4g | Experimental | Atorvastatin calcium 20mg, Omega-3-acids ethylesters 90 4g: po, q.d Receives: Drug: Atorvastatin 20mg; Drug: Omega-3-acids ethylesters 90 4g |
| Atorvastatin 20mg, Placebo | Placebo comparator | Atorvastatin calcium 20mg, Placebo for Omega-3-acids ethylesters 90 4g: po, q.d Receives: Drug: Atorvastatin 20mg; Other: Placebo(Omega-3-acids ethylesters 90) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean percent change of Triglyceride(TG)
Measured: from baseline at week 8
Secondary outcomes (2)
The mean percent change of Triglyceride(TG)
Measured: from baseline at week 4
The mean percent change of Total Cholesterol(TC), LDL-C, HDL-C
Measured: from baseline at week 4,8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionOct 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperlipidemia, Familial CombinedStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kuhnil Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hong Seog Seo, Ph.D., Principal investigator, Korea University Guro HospitalHee Kyoung Cheon, Ph.D., Principal investigator, Uijongbu St. Mary's HospitalSang-Ho Jo, Ph.d., Principal investigator, Hallym University Medical CenterMi-Seung Shin, Ph.D, Principal investigator, Gachon University Gil Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02035215
- Sponsor's protocol ID
- 13-OM-8302
- Status last verified
- Mar 2014
- First submitted
- 10 Jan 2014
- Last updated
- 20 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Co-administration of Omacor Plus Atorvastatin Compared With Atorvastatin Monotherapy in Patients With Type Ⅱb Dyslipidemia: a Multicenter, Double-blind, Randomized, Active-controlled, Parallel, Phase Ⅲ Study
- ClinicalTrials.gov ID
- NCT02035215
- Acronym / sponsor ID
- 13-OM-8302
- Conditions
- Hyperlipidemia, Familial Combined
- Keywords
- Hyperlipidemia, Familial Combined, Omega 3 acids ethylesters 90, Atorvastatin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Kuhnil Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 14 Jan 2014 (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 purpose of this study is to evaluate the efficacy and safety of combination therapy of omega-3-acids ethylesters 90/Atorvastatin calcium in type Ⅱb hyperlipidemia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin 20mg, Omega-3-acids ethylesters 90 4g | Experimental | Drug: Atorvastatin 20mg, Drug: Omega-3-acids ethylesters 90 4gAtorvastatin calcium 20mg, Omega-3-acids ethylesters 90 4g: po, q.d |
| Atorvastatin 20mg, Placebo | Placebo comparator | Drug: Atorvastatin 20mg, Other: Placebo(Omega-3-acids ethylesters 90)Atorvastatin calcium 20mg, Placebo for Omega-3-acids ethylesters 90 4g: po, q.d |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- LDL≥160mg/dl, 200mg/dl≤TG<500mg/dl
- In the case of smokers, he agrees should be smoke-free
- In the case of women of childbearing age, urine pregnancy test must be negative
Key exclusion criteria (18 listed)
- Patients with acute artery disease within 3 months
- History of revascularization procedure or aneurism operation within 6months
- Patients with myopathy, rhabdomyolysis
- Patients with pancreatitis
- Patients with HIV positive
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 |
|---|---|---|
| Atorvastatin 20mgAlso: Lipitor 20mg | Drug | Atorvastatin 20mg, Omega-3-acids ethylesters 90 4g, Atorvastatin 20mg, Placebo |
| Omega-3-acids ethylesters 90 4gAlso: Omacor Soft Capsule 4g | Drug | Atorvastatin 20mg, Omega-3-acids ethylesters 90 4g |
| Placebo(Omega-3-acids ethylesters 90) | Other | Atorvastatin 20mg, Placebo |
Primary outcome
The mean percent change of Triglyceride(TG)
Time frame: from baseline at week 8
2 secondary outcomes
The mean percent change of Triglyceride(TG)
Time frame: from baseline at week 4
The mean percent change of Total Cholesterol(TC), LDL-C, HDL-C
Time frame: from baseline at week 4,8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 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.
Hong Seog Seo, Ph.D. principal investigator
Korea University Guro Hospital
Hee Kyoung Cheon, Ph.D. principal investigator
Uijongbu St. Mary's Hospital
Sang-Ho Jo, Ph.d. principal investigator
Hallym University Medical Center
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 Atorvastatin 20mg and Omega-3-acids ethylesters 90 4g in people with Hyperlipidemia, Familial Combined, run by Kuhnil Pharmaceutical Co., Ltd. at 4 sites in South Korea.
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 18 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 20 Mar 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kuhnil Clinical Research Team (+82-2-2175-9760, jmhong@kuhnil.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean percent change of Triglyceride(TG) (time frame: from baseline at week 8). 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 Mar 2014.