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Phase 3 Study to Evaluate the Efficacy and Safety of Omega-3-acids Ethylesters 90 in Type Ⅱb Hyperlipidemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02035215
Recruitment Status : Unknown
Verified March 2014 by Kuhnil Pharmaceutical Co., Ltd..
Recruitment status was:  Recruiting
First Posted : January 14, 2014
Last Update Posted : March 20, 2014
Information provided by (Responsible Party):
Kuhnil Pharmaceutical Co., Ltd.

Brief 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

Condition or disease Intervention/treatment Phase
Hyperlipidemia, Familial Combined Drug: Atorvastatin 20mg Drug: Omega-3-acids ethylesters 90 4g Other: Placebo(Omega-3-acids ethylesters 90) Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : January 2014
Estimated Primary Completion Date : October 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Atorvastatin 20mg, Omega-3-acids ethylesters 90 4g
Atorvastatin calcium 20mg, Omega-3-acids ethylesters 90 4g: po, q.d
Drug: Atorvastatin 20mg
Other Name: Lipitor 20mg

Drug: Omega-3-acids ethylesters 90 4g
Other Name: Omacor Soft Capsule 4g

Placebo Comparator: Atorvastatin 20mg, Placebo
Atorvastatin calcium 20mg, Placebo for Omega-3-acids ethylesters 90 4g: po, q.d
Drug: Atorvastatin 20mg
Other Name: Lipitor 20mg

Other: Placebo(Omega-3-acids ethylesters 90)

Primary Outcome Measures :
  1. The mean percent change of Triglyceride(TG) [ Time Frame: from baseline at week 8 ]

Secondary Outcome Measures :
  1. The mean percent change of Triglyceride(TG) [ Time Frame: from baseline at week 4 ]
  2. The mean percent change of Total Cholesterol(TC), LDL-C, HDL-C [ Time Frame: from baseline at week 4,8 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02035215

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Contact: Kuhnil Clinical Research Team +82-2-2175-9760

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Korea, Republic of
Hallym University Sacred Heart Hospital Active, not recruiting
Anyang, Gyeonggi, Korea, Republic of, 431-070
Gachon University Gil Hospital Not yet recruiting
Incheon, Korea, Republic of, 405-760
Korea University Guro Hospital Recruiting
Seoul, Korea, Republic of, 152-703
Uijongbu St. Mary's Hospital Active, not recruiting
Uijongbu, Gyeonggi, Korea, Republic of, 480-717
Sponsors and Collaborators
Kuhnil Pharmaceutical Co., Ltd.
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Principal Investigator: Hong Seog Seo, Ph.D. Korea University Guro Hospital
Principal Investigator: Hee Kyoung Cheon, Ph.D. Uijongbu St. Mary's Hospital
Principal Investigator: Sang-Ho Jo, Ph.d. Hallym University Medical Center
Principal Investigator: Mi-Seung Shin, Ph.D Gachon University Gil Medical Center
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Responsible Party: Kuhnil Pharmaceutical Co., Ltd. Identifier: NCT02035215    
Other Study ID Numbers: 13-OM-8302
First Posted: January 14, 2014    Key Record Dates
Last Update Posted: March 20, 2014
Last Verified: March 2014
Keywords provided by Kuhnil Pharmaceutical Co., Ltd.:
Hyperlipidemia, Familial Combined
Omega 3 acids ethylesters 90
Additional relevant MeSH terms:
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Hyperlipidemia, Familial Combined
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors