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news.LifeCycle Pharma has announced that it will initiate a Phase II clinical trial program using LCP-AtorFen, a fixed-dose combination of atorvastatin and fenofibrate, for the treatment of high cholesterol levels.
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LCP-AtorFen will address three primary cardiovascular risk factors: low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C) and triglycerides (TG).
The trial is designed as a double-blind, randomized, active controlled study to compare LCP-AtorFen with Lipitor and Tricor in around 200 patients with mixed dyslipidemia over 12 weeks, followed by an open-label extension study for one year.
“This trial is supposed to give us substantial guidance for planning a Phase III program in different patient populations”, said Dr Michael Beckert, chief medical officer at LifeCycle Pharma.
“LCP-AtorFen, the combination of one of the most potent and safe statins (atorvastatin) plus a safe and efficacious fibrate (fenofibrate), opens the opportunity to address all angles of the atherogenic triad (LDL-C, HDL-C and Triglycerides) in one single pill”, said Dr Michael Davidson, one of the clinical investigators for the study.