Efficacy and Safety of Fenofibrate Added on to Atorvastatin Compared With Atorvastatin in Mixed Hypercholesterolemic Patient(CKD-337)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Chong Kun Dang Pharmaceutical
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01956201
First received: September 30, 2013
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention Phase
Mixed Hyperlipidemia
Drug: Atorvastatin 20mg
Drug: Fenofibrate 160mg
Other: Placebo (Fenofibrate 160 mg)
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Chong Kun Dang Pharmaceutical:

Primary Outcome Measures:
  • The mean percent change of Non-HDL Cholesterol [ Time Frame: from baseline at week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The achievement rate of LDL-C<100mg/dl, Non-HDL-C<130mg/dl [ Time Frame: from baseline at week 8 ] [ Designated as safety issue: No ]
  • The mean percent change of LDL-C, HDL-C, TG, TC, Apo-AI, Apo-B [ Time Frame: from baseline at week 4, 8 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • The mean percent change of Fibrinogen, hs-CRP [ Time Frame: from baseline at week 4, 8 ] [ Designated as safety issue: No ]

Estimated Enrollment: 476
Study Start Date: December 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Atorvastatin 20mg, Fenofibrate 160mg
Atorvastatin 20mg, Fenofibrate 160mg: po, q.d.
Drug: Atorvastatin 20mg
Other Name: Lipilou Tab.
Drug: Fenofibrate 160mg
Other Name: fenofibrate 160mg
Active Comparator: Atorvastatin 20mg, Placebo
Atorvastatin 20mg, Placebo for Fenofibrate 160mg po, q.d.
Drug: Atorvastatin 20mg
Other Name: Lipilou Tab.
Other: Placebo (Fenofibrate 160 mg)
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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≤8.0%)
    4. 10-year risk of CHD >20%(by Framingham 10-year risk score calculation)
  • At Visit 1(Screening)

    1. 130mg/dl≥LDL-C, 150mg/dl≤TG≤400mg/dl

      • 4weeks of Atorvastatin 20mg monotherapy run-in period
    2. LDL-C<100mg/dl, 150mg/dl≤TG≤400mg/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≤400mg/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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01956201

Contacts
Contact: Hyun-Kyung Oh 82-2-2194-0469 hkoh@ckdpharm.com

Locations
Korea, Republic of
Pusan National University Hospital Not yet recruiting
Busan, Korea, Republic of
Contact: Sangsu Kim         
Inje University Busan Paik Hospital Not yet recruiting
Busan, Korea, Republic of
Contact: DaeKyung Kim         
Kangwon University Hospital Not yet recruiting
Chuncheon, Korea, Republic of
Contact: Yonghoon Kim         
Keimyung University Dongsan Medical Center Not yet recruiting
Daegu, Korea, Republic of
Contact: HoChan Cho         
Daegu Catholic University Medical Center Not yet recruiting
Daegu, Korea, Republic of
Contact: Hosang Son         
Konyang University Hospital Recruiting
Daejeon, Korea, Republic of
Contact: Jangho Bae         
Chonnam National University Hospital Not yet recruiting
Gwangju, Korea, Republic of
Contact: YoungKun Ahn         
Inje University Ilsan Paik Hospital Not yet recruiting
Ilsan, Korea, Republic of
Contact: SungYoon Lee         
Dongguk University Ilsan Hospital Not yet recruiting
Ilsan, Korea, Republic of
Contact: KyungAh Kim         
Chonbuk National University Hospital Not yet recruiting
Jeonju, Korea, Republic of
Contact: Jaegun Chae         
Hanyang University Guri Hospital Not yet recruiting
Kyunggi, Korea, Republic of
Contact: Changmum Lee         
Seoul National University Hospital, Bundang Not yet recruiting
Seongnam, Korea, Republic of
Contact: Soo Lim         
Seoul National University Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: HyeSeung Jung         
The Catholic University of korea, Yeouido St. Mary's Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: HyukSang Kwon         
Eulji General Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: KyungAh Han         
Korea University Anam Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Singon Kim         
Korea University Huro Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: KyungMuk Choi         
Kyunghee University Hospital at Gangdong Not yet recruiting
Seoul, Korea, Republic of
Contact: Jinman Cho         
Kangbuk Samsung Medical Center Not yet recruiting
Seoul, Korea, Republic of
Contact: KiChul Sung         
The Catholic University of Korea, Uijeongbu St. Mary's Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: HyunSik Son         
SMG-SNU Boramae Medical Center Not yet recruiting
Seoul, Korea, Republic of
Contact: SangHyun Kim         
Kyunghee University Medical center Not yet recruiting
Seoul, Korea, Republic of
Contact: Woosik Kim         
The Catholic University of Korea, St. Mary's Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: SangHong Baik         
Samsung Medical Center Not yet recruiting
Seoul, Korea, Republic of
Contact: MoonKyu Lee, M.D., Ph.D.         
Asan Medical Center Not yet recruiting
Seoul, Korea, Republic of
Contact: Kihoon Han         
Kangdong Sacred Heart Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Duman Kim         
Gangnam Severance Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Youngwon Yoon         
Severance Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Sanghak Lee         
Ajou University hospital Not yet recruiting
Suwon, Korea, Republic of
Contact: DaeJung Kim         
Wonju Severance Christian Hospital Not yet recruiting
Wonju, Korea, Republic of
Contact: Byungsoo Yoo         
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
Principal Investigator: MoonKyu Lee, M.D. , Ph.D. Samsung Medical Center - Seoul
  More Information

No publications provided

Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT01956201     History of Changes
Other Study ID Numbers: 146MHL13011
Study First Received: September 30, 2013
Last Updated: April 2, 2014
Health Authority: South Korea: Ministry of Food and Drug Safety

Additional relevant MeSH terms:
Hyperlipidemia, Familial Combined
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Fenofibrate
Atorvastatin
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 24, 2014