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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02035215

Enrollment

Registered

2014-01-14

Start date

2014-01-31

Completion date

2014-12-31

Last updated

2014-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperlipidemia, Familial Combined

Keywords

Hyperlipidemia, Familial Combined, Omega 3 acids ethylesters 90, Atorvastatin

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

Interventions

DRUGAtorvastatin 20mg

DRUGOmega-3-acids ethylesters 90 4g

OTHERPlacebo(Omega-3-acids ethylesters 90)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The mean percent change of Triglyceride(TG)	from baseline at week 8

Secondary

Measure	Time frame
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

Countries

South Korea

Contacts

Primary ContactKuhnil Clinical Research Team

jmhong@kuhnil.com+82-2-2175-9760

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026