Conditions: Dyslipidemia
Keywords: LCP-AtorFen Non-HDL cholesterol Triglycerides HDL cholesterol LDL cholesterol Atorvastatin Fenofibrate
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 220
Healthy volunteers: no

Brief summary:
The current study is designed to test the efficacy, safety and tolerability of LCP-AtorFen, a combination of atorvastatin and fenofibrate.

Detailed description:
This is a multicenter, randomized, double-blind, 12 week study with a 52-week open-label follow-up to evaluate the safety and efficacy of LCP-AtorFen (the combination of atorvastatin and fenofibrate) in the treatment of hyperlipidemia.

After a wash-out phase, eligible patients will be randomized on a 1:1:1 ratio to either LCP-AtorFen, atorvastatin or fenofibrate for 12 weeks. After the completion of the 12-week phase, all eligible patients will be offered to receive open-label LCP-AtorFen for another 52 weeks.

Arms:
arm 1: LCP-AtorFen 40/100mg fixed-dose combination tablet of 40mg atorvastatin and 145mg fenofibrate for treatment of mixed dyslipidemia arm 2: atorvastatin 40mg tablet (Lipitor), as an adjunct to diet and exercise for treatment of mixed dyslipidemia arm 3: fenofibrate 145mg tablet (Tricor), as an adjunct to diet and exercise for treatment of mixed dyslipidemia

Interventions: intervention 1: LCP-AtorFen intervention 2: atorvastatin intervention 3: fenofibrate
Intervention descriptions: intervention 1: 40mg atorvastatin combined with 100mg fenofibrate in a tablet for once daily treatment of dyslipidemia and mixed dyslipidemia intervention 2: dyslipidemia and mixed dyslipidemia intervention 3: dyslipidemia and mixed dyslipidemia

Protocol document: