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

Hyperlipidemia, Familial Combined Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02035215
• Other study ID #: 13-OM-8302
• Status: Recruiting
• Phase: Phase 3
• First received: January 10, 2014
• Last updated: March 19, 2014
• Start date: January 2014
• Est. completion date: December 2014

Study information

• Verified date: March 2014
• Source: Kuhnil Pharmaceutical Co., Ltd.
• Contact: Kuhnil Clinical Research Team
• Phone: +82-2-2175-9760
• Email: jmhong[@]kuhnil.com
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperlipidemia, Familial Combined
• Hyperlipidemias

Intervention

Drug:
• Atorvastatin 20mg

• Omega-3-acids ethylesters 90 4g

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

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Sacred Heart Hospital	Anyang, Gyeonggi
Korea, Republic of	Gachon University Gil Hospital	Incheon
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Uijongbu St. Mary`s Hospital	Uijongbu, Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
Kuhnil Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The mean percent change of Triglyceride(TG)		from baseline at week 8	No
Secondary	The mean percent change of Triglyceride(TG)		from baseline at week 4	No
Secondary	The mean percent change of Total Cholesterol(TC), LDL-C, HDL-C		from baseline at week 4,8	No