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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorKowa Company, Ltd.

About this trial

To investigate the efficacy and safety of Pemafibrate 0.2 mg/day or 0.4 mg/day for 12 weeks in patients with hypercholesterolemia and inadequate response to statins, using placebo as a control.

Eligibility criteria

Qualifiers

Patients with hypercholesterolemia aged 18 years or older at the time of obtaining written informed consent

Patients who have taken statins at a fixed dose and regimen within the approved dose range for at least four weeks prior to the first screening assessment.

Patients who have received stable dietary and/or exercise therapy for at least 12 weeks prior to the first screening assessment.

Patients with the fasting serum TG < 150 mg/dL on two consecutive occasions at screening

Disqualifiers

Patients who require administration of prohibited drugs during the post-marketing clinical trial period after written informed consent

Patients with type 1 diabetes and uncontrolled type 2 diabetes [HbA1c(NGSP) >= 10.0 % at Screening]

Patients whose LDL-C level changed by more than +20% or -20% in the second screening test compared to the the first.

Patients with uncontrolled thyroid disease

Trial design

Treatments tested in this trial

  • Pemafibrate 0.2 mg/day
  • Pemafibrate 0.4 mg/day
  • Placebo

Treatment groups

120 Participants
are divided into 3 treatment groups

Sponsors and collaborators