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

February 2, 2015 updated by: Chong Kun Dang Pharmaceutical

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.

The purpose of this study is to evaluate the efficacy and safety of Atorvastatin and Fenofibrate compared with atorvastatin monotherapy in mixed hypercholesterolemic patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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]

Study Type

Interventional

Enrollment (Anticipated)

476

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of
        • Recruiting
        • Pusan National University Hospital
        • Contact:
          • Sangsu Kim
      • Busan, Korea, Republic of
        • Recruiting
        • Inje University Busan Paik Hospital
        • Contact:
          • DaeKyung Kim
      • Chuncheon, Korea, Republic of
        • Recruiting
        • Kangwon University Hospital
        • Contact:
          • Yonghoon Kim
      • Daegu, Korea, Republic of
        • Recruiting
        • Keimyung University Dongsan Medical Center
        • Contact:
          • HoChan Cho
      • Daegu, Korea, Republic of
        • Recruiting
        • Daegu Catholic University Medical Center
        • Contact:
          • Hosang Son
      • Daejeon, Korea, Republic of
        • Recruiting
        • Konyang University Hospital
        • Contact:
          • Jangho Bae
      • Gwangju, Korea, Republic of
        • Recruiting
        • Chonnam National University Hospital
        • Contact:
          • YoungKun Ahn
      • Ilsan, Korea, Republic of
        • Recruiting
        • Inje University Ilsan Paik Hospital
        • Contact:
          • SungYoon Lee
      • Ilsan, Korea, Republic of
        • Recruiting
        • Dongguk University Ilsan Hospital
        • Contact:
          • KyungAh Kim
      • Jeonju, Korea, Republic of
        • Recruiting
        • Chonbuk National University Hospital
        • Contact:
          • Jaegun Chae
      • Kyunggi, Korea, Republic of
        • Recruiting
        • Hanyang University Guri Hospital
        • Contact:
          • Changmum Lee
      • Seongnam, Korea, Republic of
        • Recruiting
        • Seoul National University Hospital, Bundang
        • Contact:
          • Soo Lim
      • Seoul, Korea, Republic of
        • Recruiting
        • Asan Medical Center
        • Contact:
          • Kihoon Han
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Hospital
        • Contact:
          • HyeSeung Jung
      • Seoul, Korea, Republic of
        • Recruiting
        • Gangnam Severance Hospital
        • Contact:
          • Youngwon Yoon
      • Seoul, Korea, Republic of
        • Recruiting
        • Severance Hospital
        • Contact:
          • Sanghak Lee
      • Seoul, Korea, Republic of
        • Recruiting
        • Samsung Medical Center
        • Contact:
          • MoonKyu Lee, M.D., Ph.D.
      • Seoul, Korea, Republic of
        • Recruiting
        • Korea University Anam Hospital
        • Contact:
          • Singon Kim
      • Seoul, Korea, Republic of
        • Recruiting
        • Kyunghee University Medical Center
        • Contact:
          • Woosik Kim
      • Seoul, Korea, Republic of
        • Recruiting
        • The Catholic University of Korea, Yeouido St. Mary's Hospital
        • Contact:
          • HyukSang Kwon
      • Seoul, Korea, Republic of
        • Recruiting
        • Kangdong Sacred Heart Hospital
        • Contact:
          • Duman Kim
      • Seoul, Korea, Republic of
        • Recruiting
        • Kangbuk Samsung Medical Center
        • Contact:
          • KiChul Sung
      • Seoul, Korea, Republic of
        • Recruiting
        • SMG-SNU Boramae Medical Center
        • Contact:
          • SangHyun Kim
      • Seoul, Korea, Republic of
        • Recruiting
        • Eulji General Hospital
        • Contact:
          • KyungAh Han
      • Seoul, Korea, Republic of
        • Recruiting
        • The Catholic University of Korea, St. Mary's Hospital
        • Contact:
          • SangHong Baik
      • Seoul, Korea, Republic of
        • Recruiting
        • Kyunghee University Hospital at Gangdong
        • Contact:
          • Kyujung Ahn
      • Seoul, Korea, Republic of
        • Recruiting
        • Korea University Huro Hospital
        • Contact:
          • KyungMuk Choi
      • Seoul, Korea, Republic of
        • Recruiting
        • The Catholic University of Korea, Uijeongbu ST. Mary's Hospital
        • Contact:
          • HyunSik Son
      • Suwon, Korea, Republic of
        • Recruiting
        • Ajou University Hospital
        • Contact:
          • DaeJung Kim
      • Wonju, Korea, Republic of
        • Recruiting
        • Wonju Severance Christian Hospital
        • Contact:
          • Byungsoo Yoo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Atorvastatin 20mg, Fenofibrate 160mg
Atorvastatin 20mg, Fenofibrate 160mg: po, q.d.
Drug: Atorvastatin 20mg
[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)
Other Names:
  • Lipilou Tab.
Drug: Fenofibrate 160mg
Refer to Intervention Description of Atorvastatin 20mg
ACTIVE_COMPARATOR: Atorvastatin 20mg, Placebo
Atorvastatin 20mg, Placebo for Fenofibrate 160mg po, q.d.
Drug: Atorvastatin 20mg
[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)
Other Names:
  • Lipilou Tab.
Other: Placebo (Fenofibrate 160 mg)
Refer to Intervention Description of Atorvastatin 20mg
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The mean percent change of Non-HDL Cholesterol
Time Frame: from baseline at week 8
from baseline at week 8

Secondary Outcome Measures

Outcome Measure
Time Frame
The achievement rate of LDL-C<100mg/dl, Non-HDL-C<130mg/dl
Time Frame: from baseline at week 8
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
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
from baseline at week 4, 8
The mean percent change of Fibrinogen, hs-CRP
Time Frame: from baseline at week 4, 8
from baseline at week 4, 8
Safety evaluation (Physical examination, Vital sign, Laboratory, AE etc.)
Time Frame: Treatment period (8 weeks) and Extension period (16 weeks)
Treatment period (8 weeks) and Extension period (16 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chong Kun Dang Pharmaceutical

Investigators

  • Principal Investigator: MoonKyu Lee, M.D., Ph.D., Samsung Medical Center - Seoul

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (ANTICIPATED)

August 1, 2016

Study Completion (ANTICIPATED)

August 1, 2016

Study Registration Dates

First Submitted

September 30, 2013

First Submitted That Met QC Criteria

September 30, 2013

First Posted (ESTIMATE)

October 8, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

February 4, 2015

Last Update Submitted That Met QC Criteria

February 2, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 146MHL13011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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