Last updated on February 2015

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


Brief description of 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.

Detailed Study 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]

Clinical Study Identifier: NCT01956201

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Kangwon University Hospital

Chuncheon, Korea, Republic of
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Konyang University Hospital

Daejeon, Korea, Republic of
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Asan Medical Center

Seoul, Korea, Republic of
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Eulji General Hospital

Seoul, Korea, Republic of
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Gangnam Severance Hospital

Seoul, Korea, Republic of
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Samsung Medical Center

Seoul, Korea, Republic of
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Severance Hospital

Seoul, Korea, Republic of
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Ajou University hospital

Suwon, Korea, Republic of
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Recruitment Status: Open


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