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

  • STATUS
    Not Recruiting
  • participants needed
    476
  • sponsor
    Chong Kun Dang Pharmaceutical
Updated on 21 January 2021
Chonbuk National University Hospital (0.0 mi away) Contact

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.

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]

Details
Condition Familial combined hyperlipidemia
Treatment Atorvastatin 20mg, Fenofibrate 160mg, Placebo (Fenofibrate 160 mg)
Clinical Study IdentifierNCT01956201
SponsorChong Kun Dang Pharmaceutical
Last Modified on21 January 2021

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