Clinical Trial: Efficacy and Safety of Fenofibrate Added on to Atorvastatin Compared With Atorvastatin

Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional

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 Confir

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 Summary:

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]


Sponsor: Chong Kun Dang Pharmaceutical

Current Primary Outcome: The mean percent change of Non-HDL Cholesterol [ Time Frame: from baseline at week 8 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 (Physical examination, Vital sign, Laboratory, AE etc.) [ Time Frame: Treatment period (8 weeks) and Extension period (16 weeks) ]


Original Secondary Outcome:

  • 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 ]


Information By: Chong Kun Dang Pharmaceutical

Dates:
Date Received: September 30, 2013
Date Started: December 2013
Date Completion: August 2016
Last Updated: February 2, 2015
Last Verified: February 2015