Clinical trial NCT02035215: Phase 3 Study to Evaluate the Efficacy and Safety of Omega-3-acids Ethylesters 90 in Type Ⅱb Hyperlipidemia
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hyperlipidemia, Familial Combined
Keywords: Hyperlipidemia, Familial Combined
Omega 3 acids ethylesters 90
Atorvastatin
Lead sponsor: Kuhnil Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-01-14
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: The mean percent change of Triglyceride(TG)
timeFrame: from baseline at week 8
Secondary outcomes:
measure: The mean percent change of Triglyceride(TG)
timeFrame: from baseline at week 4
measure: The mean percent change of Total Cholesterol(TC), LDL-C, HDL-C
timeFrame: from baseline at week 4,8
Other outcomes:
Locations:
city: Anyang, Gyeonggi
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Uijongbu, Gyeonggi
country: Korea, Republic of
facility: Uijongbu St. Mary's Hospital
Study officials:
affiliation: Korea University Guro Hospital
name: Hong Seog Seo, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Uijongbu St. Mary's Hospital
name: Hee Kyoung Cheon, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hallym University Medical Center
name: Sang-Ho Jo, Ph.d.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gachon University Gil Medical Center
name: Mi-Seung Shin, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: