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Efficacy and Safety of Fenofibrate Added on to Atorvastatin Compared With Atorvastatin

Primary Purpose

Mixed Hyperlipidemia

Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Atorvastatin 20mg
Fenofibrate 160mg
Placebo (Fenofibrate 160 mg)
Sponsored by
Chong Kun Dang Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mixed Hyperlipidemia

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • >19 years old

  • High risk patient to Coronary Heart Disease (applied to 1 or more CHD risk factor listed below)

    1. Patient with Coronary Heart Disease
    2. Patient with carotid artery disease, peripheral blood vessel disease, abdominal aneurysm
    3. Patient with diabetes(HbA1C≤9.0%)
    4. 10-year risk of CHD >20%(by Framingham 10-year risk score calculation)

  • At Visit 1(Screening)

    1. 100mg/dl≥LDL-C, 150mg/dl≤TG≤500mg/dl

      • 4weeks of Atorvastatin 20mg monotherapy run-in period

    2. LDL-C<100mg/dl, 150mg/dl≤TG≤500mg/dl

      • If treated with Atorvastatin 20mg monotherapy 4weeks prior to this study

  • At Visit 2(After 4weeks of Atorvastatin monotherapy run-in period)

    • LDL<100mg/dl, 150mg/dl≤TG≤500mg/dl

Exclusion Criteria:

  • Patients with acute artery disease within 3 months
  • Patients with congestive heart failure(NYHA class III~IV) or uncontrolled arrhythmia within 6 months
  • Patients with uncontrolled hypertension(SBP>160mmHg or DBP>95mmHg)
  • TSH>1.5X ULN
  • Patients with myopathy, rhabdomyolysis or CK>2X ULN
  • Hypersensitive to Atorvastatin and/or Fenofibrate or had photoallergy or phototoxicity during fibrate and/or ketoprofen treatment
  • Serum Creatinine>2.5mg/dl, AST or ALT > 2X ULN
  • History of drug or alcohol abuse within 6 months
  • History of GI tract surgery or disability to drug absorption
  • Women with pregnant, breast-feeding
  • Patients with gallbladder disease
  • Patients with biliary cirrhosis
  • Patients with pancreatitis(acute pancreatitis is excluded due to severe hypertriglyceridemia)
  • Patients treated with any investigational drugs within 4 weeks at the time consents are obtained
  • History of malignant tumor including leukemia, lymphoma within 5 years
  • Patients must be treated with medications prohibited for concomitant use during study period
  • Not eligible to participate for the study at the discretion of investigator

Sites / Locations

  • Inje University Busan Paik HospitalRecruiting
  • Pusan National University HospitalRecruiting
  • Kangwon University HospitalRecruiting
  • Daegu Catholic University Medical CenterRecruiting
  • Keimyung University Dongsan Medical CenterRecruiting
  • Konyang University HospitalRecruiting
  • Chonnam National University HospitalRecruiting
  • Dongguk University Ilsan HospitalRecruiting
  • Inje University Ilsan Paik HospitalRecruiting
  • Chonbuk National University HospitalRecruiting
  • Hanyang University Guri HospitalRecruiting
  • Seoul National University Hospital, BundangRecruiting
  • Asan Medical CenterRecruiting
  • Eulji General HospitalRecruiting
  • Gangnam Severance HospitalRecruiting
  • Kangbuk Samsung Medical CenterRecruiting
  • Kangdong Sacred Heart HospitalRecruiting
  • Korea University Anam HospitalRecruiting
  • Korea University Huro HospitalRecruiting
  • Kyunghee University Hospital at GangdongRecruiting
  • Kyunghee University Medical centerRecruiting
  • Samsung Medical CenterRecruiting
  • Seoul National University HospitalRecruiting
  • Severance HospitalRecruiting
  • SMG-SNU Boramae Medical CenterRecruiting
  • The Catholic University of Korea, St. Mary's HospitalRecruiting
  • The Catholic University of Korea, Uijeongbu St. Mary's HospitalRecruiting
  • The Catholic University of korea, Yeouido St. Mary's HospitalRecruiting
  • Ajou University hospitalRecruiting
  • Wonju Severance Christian HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Atorvastatin 20mg, Fenofibrate 160mg

Atorvastatin 20mg, Placebo

Arm Description

Atorvastatin 20mg, Fenofibrate 160mg: po, q.d.

Atorvastatin 20mg, Placebo for Fenofibrate 160mg po, q.d.

Outcomes

Primary Outcome Measures

The mean percent change of Non-HDL Cholesterol

Secondary Outcome Measures

The achievement rate of LDL-C<100mg/dl, Non-HDL-C<130mg/dl
The mean percent change of LDL-C, HDL-C, TG, TC, Apo-AI, Apo-B
The mean percent change of Non-LDL-C/HDL-C, TC/HDL-C, LDL-C/HDL-C, Apo-B/Apo-AI
The mean percent change of Fibrinogen, hs-CRP
Safety evaluation (Physical examination, Vital sign, Laboratory, AE etc.)

Full Information

First Posted
September 30, 2013
Last Updated
February 2, 2015
Sponsor
Chong Kun Dang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT01956201
Brief Title
Efficacy and Safety of Fenofibrate Added on to Atorvastatin Compared With Atorvastatin
Official Title
Efficacy and Safety of Fenofibrate Added on to Atorvastatin Compared With Atorvastatin in Mixed Hypercholesterolemic Patient: Multi Center, Randomized, Double-blind, Parallel-group, Therapeutic Confirmatory Study.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
August 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chong Kun Dang Pharmaceutical

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Atorvastatin and Fenofibrate compared with atorvastatin monotherapy in mixed hypercholesterolemic patients.
Detailed Description
Multi center, randomized, double-blind, parallel-group, therapeutic confirmatory study Primary Outcome Measure: The mean percent change of Non-HDL Cholesterol [Time Frame: from baseline at week 8] Secondary Outcome Measures: The achievement rate of LDL-C<100mg/dl, Non-HDL-C<130mg/dl [Time Frame: from baseline at week 8] The mean percent change of LDL-C, HDL-C, TG, TC, Apo-AI, Apo-B [Time Frame: from baseline at week 4, 8] The mean percent change of Non-LDL-C/HDL-C, TC/HDL-C, LDL-C/HDL-C, Apo-B/Apo-AI [Time Frame: from baseline at week 4, 8] The mean percent change of Fibrinogen, hs-CRP [Time Frame: from baseline at week 4, 8] Safety evaluation [Time Frame: Treatment period and Extension period]

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mixed Hyperlipidemia

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Atorvastatin 20mg, Fenofibrate 160mg
Arm Type
Experimental
Arm Description
Atorvastatin 20mg, Fenofibrate 160mg: po, q.d.
Arm Title
Atorvastatin 20mg, Placebo
Arm Type
Active Comparator
Arm Description
Atorvastatin 20mg, Placebo for Fenofibrate 160mg po, q.d.
Intervention Type
Drug
Intervention Name(s)
Atorvastatin 20mg
Other Intervention Name(s)
Lipilou Tab.
Intervention Description
[Atorvastatin Run-in Period] Take Atorvastatin 20mg 1 tablet once a day (after breakfast) [Treatment Period] Take Atrovastatin 20mg/Fenofibrate 160mg or Atorvastiatin 20mg/Placebo of Finofibrate 160mg 2 tablet once a day (after breakfast) [Extension Period] Take Atrovastatin 20mg, Fenofibrate 160mg 2 tablet once a day (after breakfast)
Intervention Type
Drug
Intervention Name(s)
Fenofibrate 160mg
Intervention Description
Refer to Intervention Description of Atorvastatin 20mg
Intervention Type
Other
Intervention Name(s)
Placebo (Fenofibrate 160 mg)
Other Intervention Name(s)
Placebo
Intervention Description
Refer to Intervention Description of Atorvastatin 20mg
Primary Outcome Measure Information:
Title
The mean percent change of Non-HDL Cholesterol
Time Frame
from baseline at week 8
Secondary Outcome Measure Information:
Title
The achievement rate of LDL-C<100mg/dl, Non-HDL-C<130mg/dl
Time Frame
from baseline at week 8
Title
The mean percent change of LDL-C, HDL-C, TG, TC, Apo-AI, Apo-B
Time Frame
from baseline at week 4, 8
Title
The mean percent change of Non-LDL-C/HDL-C, TC/HDL-C, LDL-C/HDL-C, Apo-B/Apo-AI
Time Frame
from baseline at week 4, 8
Title
The mean percent change of Fibrinogen, hs-CRP
Time Frame
from baseline at week 4, 8
Title
Safety evaluation (Physical examination, Vital sign, Laboratory, AE etc.)
Time Frame
Treatment period (8 weeks) and Extension period (16 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: >19 years old High risk patient to Coronary Heart Disease (applied to 1 or more CHD risk factor listed below) Patient with Coronary Heart Disease Patient with carotid artery disease, peripheral blood vessel disease, abdominal aneurysm Patient with diabetes(HbA1C≤9.0%) 10-year risk of CHD >20%(by Framingham 10-year risk score calculation) At Visit 1(Screening) 100mg/dl≥LDL-C, 150mg/dl≤TG≤500mg/dl 4weeks of Atorvastatin 20mg monotherapy run-in period LDL-C<100mg/dl, 150mg/dl≤TG≤500mg/dl If treated with Atorvastatin 20mg monotherapy 4weeks prior to this study At Visit 2(After 4weeks of Atorvastatin monotherapy run-in period) LDL<100mg/dl, 150mg/dl≤TG≤500mg/dl Exclusion Criteria: Patients with acute artery disease within 3 months Patients with congestive heart failure(NYHA class III~IV) or uncontrolled arrhythmia within 6 months Patients with uncontrolled hypertension(SBP>160mmHg or DBP>95mmHg) TSH>1.5X ULN Patients with myopathy, rhabdomyolysis or CK>2X ULN Hypersensitive to Atorvastatin and/or Fenofibrate or had photoallergy or phototoxicity during fibrate and/or ketoprofen treatment Serum Creatinine>2.5mg/dl, AST or ALT > 2X ULN History of drug or alcohol abuse within 6 months History of GI tract surgery or disability to drug absorption Women with pregnant, breast-feeding Patients with gallbladder disease Patients with biliary cirrhosis Patients with pancreatitis(acute pancreatitis is excluded due to severe hypertriglyceridemia) Patients treated with any investigational drugs within 4 weeks at the time consents are obtained History of malignant tumor including leukemia, lymphoma within 5 years Patients must be treated with medications prohibited for concomitant use during study period 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
Hyun-Kyung Oh
Phone
82-2-2194-0469
Email
hkoh@ckdpharm.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MoonKyu Lee, M.D., Ph.D.
Organizational Affiliation
Samsung Medical Center - Seoul
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inje University Busan Paik Hospital
City
Busan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DaeKyung Kim
Facility Name
Pusan National University Hospital
City
Busan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sangsu Kim
Facility Name
Kangwon University Hospital
City
Chuncheon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yonghoon Kim
Facility Name
Daegu Catholic University Medical Center
City
Daegu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hosang Son
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
HoChan Cho
Facility Name
Konyang University Hospital
City
Daejeon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jangho Bae
Facility Name
Chonnam National University Hospital
City
Gwangju
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
YoungKun Ahn
Facility Name
Dongguk University Ilsan Hospital
City
Ilsan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
KyungAh Kim
Facility Name
Inje University Ilsan Paik Hospital
City
Ilsan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SungYoon Lee
Facility Name
Chonbuk National University Hospital
City
Jeonju
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaegun Chae
Facility Name
Hanyang University Guri Hospital
City
Kyunggi
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Changmum Lee
Facility Name
Seoul National University Hospital, Bundang
City
Seongnam
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soo Lim
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kihoon Han
Facility Name
Eulji General Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
KyungAh Han
Facility Name
Gangnam Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Youngwon Yoon
Facility Name
Kangbuk Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
KiChul Sung
Facility Name
Kangdong Sacred Heart Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Duman Kim
Facility Name
Korea University Anam Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Singon Kim
Facility Name
Korea University Huro Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
KyungMuk Choi
Facility Name
Kyunghee University Hospital at Gangdong
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyujung Ahn
Facility Name
Kyunghee University Medical center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Woosik Kim
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MoonKyu Lee, M.D., Ph.D.
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
HyeSeung Jung
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sanghak Lee
Facility Name
SMG-SNU Boramae Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SangHyun Kim
Facility Name
The Catholic University of Korea, St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SangHong Baik
Facility Name
The Catholic University of Korea, Uijeongbu St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
HyunSik Son
Facility Name
The Catholic University of korea, Yeouido St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
HyukSang Kwon
Facility Name
Ajou University hospital
City
Suwon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DaeJung Kim
Facility Name
Wonju Severance Christian Hospital
City
Wonju
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Byungsoo Yoo

12. IPD Sharing Statement

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Efficacy and Safety of Fenofibrate Added on to Atorvastatin Compared With Atorvastatin

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