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

Phase 3

• Conditions: Hyperlipidemia, Familial Combined
• Interventions: Drug: Atorvastatin 20mg; Drug: Omega-3-acids ethylesters 90 4g; Other: Placebo(Omega-3-acids ethylesters 90)

• Registration Number: NCT02035215
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-10
• Study First Submitted QC: 2014-01-10
• Study First Posted: 2014-01-14
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-19
• Last Update Posted: 2014-03-20
• Primary Completion: 2014-10
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atorvastatin 20mg, Omega-3-acids ethylesters 90 4g	Atorvastatin 20mg	Atorvastatin calcium 20mg, Omega-3-acids ethylesters 90 4g: po, q.d
Atorvastatin 20mg, Omega-3-acids ethylesters 90 4g	Omega-3-acids ethylesters 90 4g	Atorvastatin calcium 20mg, Omega-3-acids ethylesters 90 4g: po, q.d
Atorvastatin 20mg, Placebo	Atorvastatin 20mg	Atorvastatin calcium 20mg, Placebo for Omega-3-acids ethylesters 90 4g: po, q.d
Atorvastatin 20mg, Placebo	Placebo(Omega-3-acids ethylesters 90)	Atorvastatin calcium 20mg, Placebo for Omega-3-acids ethylesters 90 4g: po, q.d

Primary Outcome Measures

Name	Time	Method
The mean percent change of Triglyceride(TG)	from baseline at week 8

Secondary Outcome Measures

Name	Time	Method
The mean percent change of Triglyceride(TG)	from baseline at week 4
The mean percent change of Total Cholesterol(TC), LDL-C, HDL-C	from baseline at week 4,8

Trial Locations

Locations (4)

Gachon University Gil Hospital; 🇰🇷 Incheon, Korea, Republic of

Uijongbu St. Mary's Hospital; 🇰🇷 Uijongbu, Gyeonggi, Korea, Republic of

Hallym University Sacred Heart Hospital; 🇰🇷 Anyang, Gyeonggi, Korea, Republic of

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of