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NCT05923281

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

A Phase III Confirmatory Study of K-877 (Pemafibrate) in Patients With Hypercholesterolemia and Statin Intolerance-Multicenter, Placebo Controlled, Randomized, Double Blind, Parallel Group Controlled Trial in Patients With Statin Intolerant Hypercholesterolemia-
Kowa Company, Ltd.·Phase 3·ClinicalTrials.gov·drugRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Hypercholesterolemia
Drug/Device/Intervention
K-877 0.2 mg/day (once daily)
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Kowa Company, Ltd.
Location
Aichi,Chiba,Fukuoka,Hokkaido,Ibaraki,Kanagawa,Osaka,Osaka,Osaka,Saitama,Saitama,Tokyo,Tokyo,Tokyo,Tokyo, Japan
Timeline & enrollment
Phase
Phase 3
Start date
May 01, 2023
End date
Oct 31, 2024
Enrollment
60 participants
Primary outcome

Percent change from baseline in LDL-C (formula F).

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.

ICD-10 classifications
Pure hypercholesterolaemiaLipoprotein deficiencyHyperglycaemia, unspecifiedDisorders of lipoprotein metabolism and other lipidaemiasOther disorders of lipoprotein metabolism
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05923281
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05923281 through Pure Global AI's free database. This Phase 3 trial is sponsored by Kowa Company, Ltd. and is currently Recruiting. The study focuses on Hypercholesterolemia. Target enrollment is 60 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.