drugset / Trial / NCT05923281

A Phase III Confirmatory Study of K-877 (Pemafibrate) in Patients With Hypercholesterolemia and Statin Intolerance

NCT05923281

Phase 3 Completed 71 enrolled Kowa Company, Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

To investigate the efficacy and safety of K-877 Extended Release 0.2 mg/day or 0.4 mg/day for 12 weeks in patients with Statin Intolerant\* Hypercholesterolemia,using placebo as a controll. \*Statin Intolerant: Adverse events associated with statin use that cause unacceptable disturbances in the user's daily life, resulting in drug discontinuation or dose reduction.

Timeline

Start
2023-05-01
Primary completion
2024-08-07
Completion
2024-08-07

Drugs

EvaluationDrugModalityDoseRoute
Subject K-877 Unknown 0.2 mg
Subject K-877 Unknown 0.4 mg

Indications