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

NCT07634484 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-07-13

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Pemafibrate 0.2 mg/day

Administered orally once daily

DRUG

Pemafibrate 0.4 mg/day

Administered orally once daily

DRUG

Placebo

Administered orally once daily

Sponsors & Collaborators

  • Kowa Company, Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2027-07-31
Completion
2027-07-31

Countries

  • Japan

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07634484 on ClinicalTrials.gov