Efficacy and Safety of Fenofibrate Added on to Atorvastatin Compared With Atorvastatin
NCT ID: NCT01956201
Last Updated: 2015-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
476 participants
INTERVENTIONAL
2013-12-31
2016-08-31
Brief Summary
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Detailed Description
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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 \[Time Frame: Treatment period and Extension period\]
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Atorvastatin 20mg, Fenofibrate 160mg
Atorvastatin 20mg, Fenofibrate 160mg: po, q.d.
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)
Fenofibrate 160mg
Refer to Intervention Description of Atorvastatin 20mg
Atorvastatin 20mg, Placebo
Atorvastatin 20mg, Placebo for Fenofibrate 160mg po, q.d.
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)
Placebo (Fenofibrate 160 mg)
Refer to Intervention Description of Atorvastatin 20mg
Interventions
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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)
Fenofibrate 160mg
Refer to Intervention Description of Atorvastatin 20mg
Placebo (Fenofibrate 160 mg)
Refer to Intervention Description of Atorvastatin 20mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
19 Years
ALL
No
Sponsors
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Chong Kun Dang Pharmaceutical
INDUSTRY
Responsible Party
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Principal Investigators
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MoonKyu Lee, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center - Seoul
Locations
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Inje University Busan Paik Hospital
Busan, , South Korea
Pusan National University Hospital
Busan, , South Korea
Kangwon University Hospital
Chuncheon, , South Korea
Daegu Catholic University Medical Center
Daegu, , South Korea
Keimyung University Dongsan Medical Center
Daegu, , South Korea
Konyang University Hospital
Daejeon, , South Korea
Chonnam National University Hospital
Gwangju, , South Korea
Dongguk University Ilsan Hospital
Ilsan, , South Korea
Inje University Ilsan Paik Hospital
Ilsan, , South Korea
Chonbuk National University Hospital
Jeonju, , South Korea
Hanyang University Guri Hospital
Kyunggi, , South Korea
Seoul National University Hospital, Bundang
Seongnam, , South Korea
Asan Medical Center
Seoul, , South Korea
Eulji General Hospital
Seoul, , South Korea
Gangnam Severance Hospital
Seoul, , South Korea
Kangbuk Samsung Medical Center
Seoul, , South Korea
Kangdong Sacred Heart Hospital
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Korea University Huro Hospital
Seoul, , South Korea
Kyunghee University Hospital at Gangdong
Seoul, , South Korea
Kyunghee University Medical center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
SMG-SNU Boramae Medical Center
Seoul, , South Korea
The Catholic University of Korea, St. Mary's Hospital
Seoul, , South Korea
The Catholic University of Korea, Uijeongbu St. Mary's Hospital
Seoul, , South Korea
The Catholic University of korea, Yeouido St. Mary's Hospital
Seoul, , South Korea
Ajou University hospital
Suwon, , South Korea
Wonju Severance Christian Hospital
Wŏnju, , South Korea
Countries
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Central Contacts
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Facility Contacts
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DaeKyung Kim
Role: primary
Sangsu Kim
Role: primary
Yonghoon Kim
Role: primary
Hosang Son
Role: primary
HoChan Cho
Role: primary
Jangho Bae
Role: primary
YoungKun Ahn
Role: primary
KyungAh Kim
Role: primary
SungYoon Lee
Role: primary
Jaegun Chae
Role: primary
Changmum Lee
Role: primary
Soo Lim
Role: primary
Kihoon Han
Role: primary
KyungAh Han
Role: primary
Youngwon Yoon
Role: primary
KiChul Sung
Role: primary
Duman Kim
Role: primary
Singon Kim
Role: primary
KyungMuk Choi
Role: primary
Kyujung Ahn
Role: primary
Woosik Kim
Role: primary
MoonKyu Lee, M.D., Ph.D.
Role: primary
HyeSeung Jung
Role: primary
Sanghak Lee
Role: primary
SangHyun Kim
Role: primary
SangHong Baik
Role: primary
HyunSik Son
Role: primary
HyukSang Kwon
Role: primary
DaeJung Kim
Role: primary
Byungsoo Yoo
Role: primary
Other Identifiers
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146MHL13011
Identifier Type: -
Identifier Source: org_study_id
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