Clinical trial NCT01956201: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Mixed Hyperlipidemia
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2013-10-08
Enrollment: 476
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 \[Time Frame: Treatment period and Extension period\]

Eligibility 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≤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

Primary outcomes:
measure: The mean percent change of Non-HDL Cholesterol
timeFrame: from baseline at week 8
Secondary outcomes:
measure: The achievement rate of LDL-C<100mg/dl, Non-HDL-C<130mg/dl
timeFrame: from baseline at week 8
measure: The mean percent change of LDL-C, HDL-C, TG, TC, Apo-AI, Apo-B
timeFrame: from baseline at week 4, 8
measure: The mean percent change of Non-LDL-C/HDL-C, TC/HDL-C, LDL-C/HDL-C, Apo-B/Apo-AI
timeFrame: from baseline at week 4, 8
measure: The mean percent change of Fibrinogen, hs-CRP
timeFrame: from baseline at week 4, 8
measure: Safety evaluation (Physical examination, Vital sign, Laboratory, AE etc.)
timeFrame: Treatment period (8 weeks) and Extension period (16 weeks)
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Chuncheon
country: Korea, Republic of
facility: Kangwon University Hospital
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daejeon
country: Korea, Republic of
facility: Konyang University Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Ilsan
country: Korea, Republic of
facility: Dongguk University Ilsan Hospital
city: Ilsan
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
city: Kyunggi
country: Korea, Republic of
facility: Hanyang University Guri Hospital
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Hospital, Bundang
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Eulji General Hospital
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Kangdong Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Huro Hospital
city: Seoul
country: Korea, Republic of
facility: Kyunghee University Hospital at Gangdong
city: Seoul
country: Korea, Republic of
facility: Kyunghee University Medical center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Uijeongbu St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of korea, Yeouido St. Mary's Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University hospital
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
Study officials:
affiliation: Samsung Medical Center - Seoul
name: MoonKyu Lee, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: