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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2014 by Kuhnil Pharmaceutical Co., Ltd..
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Kuhnil Pharmaceutical Co., Ltd. Identifier:
First received: January 10, 2014
Last updated: March 19, 2014
Last verified: March 2014
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 Intervention Phase
Hyperlipidemia, Familial Combined
Drug: Atorvastatin 20mg
Drug: Omega-3-acids ethylesters 90 4g
Other: Placebo(Omega-3-acids ethylesters 90)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Further study details as provided by Kuhnil Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • The mean percent change of Triglyceride(TG) [ Time Frame: from baseline at week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The mean percent change of Triglyceride(TG) [ Time Frame: from baseline at week 4 ] [ Designated as safety issue: No ]
  • The mean percent change of Total Cholesterol(TC), LDL-C, HDL-C [ Time Frame: from baseline at week 4,8 ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: January 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)


Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02035215

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

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.
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
  More Information

Responsible Party: Kuhnil Pharmaceutical Co., Ltd. Identifier: NCT02035215     History of Changes
Other Study ID Numbers: 13-OM-8302 
Study First Received: January 10, 2014
Last Updated: March 19, 2014
Health Authority: Korea: Ministry of Food and Drug Safety

Keywords provided by Kuhnil Pharmaceutical Co., Ltd.:
Hyperlipidemia, Familial Combined
Omega 3 acids ethylesters 90

Additional relevant MeSH terms:
Hyperlipidemia, Familial Combined
Genetic Diseases, Inborn
Lipid Metabolism Disorders
Lipid Metabolism, Inborn Errors
Metabolic Diseases
Metabolism, Inborn Errors
Atorvastatin Calcium
Anticholesteremic Agents
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action processed this record on May 22, 2016