Study of Pemafibrate to Treat Hypercholesterolemia in Adults Not Responding Well to Statins Using Placebo Control

What this Trial Is About

Researchers are evaluating the effects of Pemafibrate, given at doses of 0.2 mgday or 0.4 mgday, in patients with hypercholesterolemia who do not respond adequately to statin therapy. This post-marketing Phase 4 clinical trial compares these doses to a placebo to assess efficacy and safety over 12 weeks. The study aims to understand how Pemafibrate impacts cholesterol levels, particularly LDL-C, in this patient group. Participants will be randomly assigned to receive either Pemafibrate at one of the two doses or a placebo, all administered orally once daily for 12 weeks. The trial uses a double-blind, parallel group design, meaning neither participants nor researchers know who receives which treatment. The treatment period is structured to monitor changes in cholesterol levels at multiple time points during the 12 weeks. During the trial, participants will have their LDL-C levels measured at baseline and at 4, 8, and 12 weeks after starting the medication. Additional lipid markers will also be assessed at these times. Safety and response to treatment will be closely monitored, including achievement of lipid management goals. The total participation time covers the 12-week treatment phase with scheduled visits and assessments throughout.

A Post-Marketing Clinical Trial of Pemafibrate in Patients ｗith Hypercholesterolemia and Inadequate Response to Statins