LifeCycle Pharma Completes Enrollment in LCP-AtorFen Trial
Danish drugmaker LifeCycle Pharma has completed patient enrollment in its Phase II trial of LCP-AtorFen for the treatment of mixed dyslipidemia.
The study is comparing LCP-AtorFen, the company’s fixed-dose combination product candidate of atorvastatin and lowest dose fenofibrate, with Lipitor (40-mg atorvastatin calcium tablets) and Tricor (145-mg fenofibrate tablets).
The 12-week, multicenter, double-blind, randomized, active-controlled trial enrolled 220 patients in the U.S. It was designed so that after a washout phase, eligible patients were randomized to either LCP-AtorFen, Lipitor or Tricor.
At the conclusion of the trial, each eligible patient will be given the opportunity to participate in an extension study in which patients will be provided a once-daily tablet of LCP-AtorFen for an additional 52 weeks.
LifeCycle said it expects to report top-line results in early 2008.