NCT01956201

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

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.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 476 (estimated)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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

Conditions

• Mixed Hyperlipidemia

Interventions

Type	Name	Description
DRUG	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)
DRUG	Fenofibrate 160mg	Refer to Intervention Description of Atorvastatin 20mg
OTHER	Placebo (Fenofibrate 160 mg)	Refer to Intervention Description of Atorvastatin 20mg

Timeline

• Start date: 2013-12-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2013-10-08
• Last updated: 2015-02-04

Locations

30 sites across 1 country: South Korea