search
Back to results

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

Primary Purpose

Hyperlipidemia, Familial Combined

Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Atorvastatin 20mg
Omega-3-acids ethylesters 90 4g
Placebo(Omega-3-acids ethylesters 90)
Sponsored by
Kuhnil Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperlipidemia, Familial Combined focused on measuring Hyperlipidemia, Familial Combined, Omega 3 acids ethylesters 90, Atorvastatin

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hallym University Sacred Heart Hospital
  • Gachon University Gil Hospital
  • Korea University Guro HospitalRecruiting
  • Uijongbu St. Mary's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Atorvastatin 20mg, Omega-3-acids ethylesters 90 4g

Atorvastatin 20mg, Placebo

Arm Description

Atorvastatin calcium 20mg, Omega-3-acids ethylesters 90 4g: po, q.d

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

Outcomes

Primary Outcome Measures

The mean percent change of Triglyceride(TG)

Secondary Outcome Measures

The mean percent change of Triglyceride(TG)
The mean percent change of Total Cholesterol(TC), LDL-C, HDL-C

Full Information

First Posted
January 10, 2014
Last Updated
March 19, 2014
Sponsor
Kuhnil Pharmaceutical Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT02035215
Brief Title
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

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
October 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kuhnil Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia, Familial Combined
Keywords
Hyperlipidemia, Familial Combined, Omega 3 acids ethylesters 90, Atorvastatin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Atorvastatin 20mg, Omega-3-acids ethylesters 90 4g
Arm Type
Experimental
Arm Description
Atorvastatin calcium 20mg, Omega-3-acids ethylesters 90 4g: po, q.d
Arm Title
Atorvastatin 20mg, Placebo
Arm Type
Placebo Comparator
Arm Description
Atorvastatin calcium 20mg, Placebo for Omega-3-acids ethylesters 90 4g: po, q.d
Intervention Type
Drug
Intervention Name(s)
Atorvastatin 20mg
Other Intervention Name(s)
Lipitor 20mg
Intervention Type
Drug
Intervention Name(s)
Omega-3-acids ethylesters 90 4g
Other Intervention Name(s)
Omacor Soft Capsule 4g
Intervention Type
Other
Intervention Name(s)
Placebo(Omega-3-acids ethylesters 90)
Primary Outcome Measure Information:
Title
The mean percent change of Triglyceride(TG)
Time Frame
from baseline at week 8
Secondary Outcome Measure Information:
Title
The mean percent change of Triglyceride(TG)
Time Frame
from baseline at week 4
Title
The mean percent change of Total Cholesterol(TC), LDL-C, HDL-C
Time Frame
from baseline at week 4,8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kuhnil Clinical Research Team
Phone
+82-2-2175-9760
Email
jmhong@kuhnil.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hong Seog Seo, Ph.D.
Organizational Affiliation
Korea University Guro Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hee Kyoung Cheon, Ph.D.
Organizational Affiliation
Uijongbu St. Mary's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sang-Ho Jo, Ph.d.
Organizational Affiliation
Hallym University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mi-Seung Shin, Ph.D
Organizational Affiliation
Gachon University Gil Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hallym University Sacred Heart Hospital
City
Anyang, Gyeonggi
ZIP/Postal Code
431-070
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Gachon University Gil Hospital
City
Incheon
ZIP/Postal Code
405-760
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
152-703
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Uijongbu St. Mary's Hospital
City
Uijongbu, Gyeonggi
ZIP/Postal Code
480-717
Country
Korea, Republic of
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs