A Phase III Confirmatory Study of K-877 (Pemafibrate) in Patients With Hypercholesterolemia and Statin Intolerance - Trial NCT05923281
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.
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Study Focus
Sponsor & Location
Kowa Company, Ltd.
Timeline & Enrollment
Phase 3
May 01, 2023
Oct 31, 2024
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
Data Source
ClinicalTrials.gov
NCT05923281
Non-Device Trial