Phase 3 Study to Evaluate the Efficacy and Safety of Omega-3-acids Ethylesters 90 in Type Ⅱb Hyperlipidemia
NCT ID: NCT02035215
Last Updated: 2014-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
80 participants
INTERVENTIONAL
2014-01-31
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Atorvastatin 20mg, Omega-3-acids ethylesters 90 4g
Atorvastatin calcium 20mg, Omega-3-acids ethylesters 90 4g: po, q.d
Atorvastatin 20mg
Omega-3-acids ethylesters 90 4g
Atorvastatin 20mg, Placebo
Atorvastatin calcium 20mg, Placebo for Omega-3-acids ethylesters 90 4g: po, q.d
Atorvastatin 20mg
Placebo(Omega-3-acids ethylesters 90)
Interventions
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Atorvastatin 20mg
Omega-3-acids ethylesters 90 4g
Placebo(Omega-3-acids ethylesters 90)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
20 Years
80 Years
ALL
No
Sponsors
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Kuhnil Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Hong Seog Seo, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Korea University Guro Hospital
Hee Kyoung Cheon, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Uijongbu St. Mary's Hospital
Sang-Ho Jo, Ph.d.
Role: PRINCIPAL_INVESTIGATOR
Hallym University Medical Center
Mi-Seung Shin, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Gachon University Gil Medical Center
Locations
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Hallym University Sacred Heart Hospital
Anyang, Gyeonggi, , South Korea
Gachon University Gil Hospital
Incheon, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Uijongbu St. Mary's Hospital
Uijongbu, Gyeonggi, , South Korea
Countries
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Central Contacts
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Other Identifiers
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13-OM-8302
Identifier Type: -
Identifier Source: org_study_id
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