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news.LifeCycle Pharma has completed patient enrollment in a Phase II trial for the treatment of mixed dyslipidemia to compare AtorFen, the company’s fixed-dose combination product candidate of atorvastatin and lowest dose fenofibrate, with Lipitor and Tricor.
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The 12-week Phase II multicenter, double-blind, randomized, active controlled clinical trial enrolled a total of 220 patients with mixed dyslipidemia, across 14 centers in the US. The clinical trial was designed so that after a wash-out phase, eligible patients were randomized on a 1:1:1 ratio to either LCP-AtorFen, atorvastatin (Lipitor) or fenofibrate (Tricor) for 12 weeks.
At the conclusion of the clinical trial each eligible patient will be given the opportunity to rollover to, and participate in, the extension study whereby patients will be provided a once-daily tablet of LCP-AtorFen for an additional 52 weeks.
Primary endpoints include assessing the non-HDL cholesterol and triglyceride lowering efficacy as well as the HDL cholesterol increasing efficacy of LCP-AtorFen versus atorvastatin (Lipitor). Secondary endpoints include assessing the non-HDL and LDL cholesterol lowering efficacy as well as the HDL cholesterol increasing efficacy of LCP-AtorFen versus fenofibrate (Tricor).
The company expects to report top-line results from the Phase II clinical trial at the end of the first quarter or early in the second quarter of 2008. The company has also initiated a 52-week, open-label extension study in order to capture additional safety and efficacy data on the use of LCP AtorFen in patients with mixed dyslipidemia.