NCT04714151

A Phase III Confirmatory Study of K-877 Extended Release Tablet

A Phase III Confirmatory Study of K-877 Extended Release Tablet-A Multicenter, Active Controlled, Randomized, Double Blind, Parallel Group Controlled Trial in Patients With Dyslipidemia With High TG-

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 356 (actual)
• Sponsor: Kowa Company, Ltd. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

To investigate the efficacy and safety of K-877 Extended Release (ER) 0.2 mg/day or 0.4 mg/day (once daily) for 12 weeks in dyslipidemia, using K-877 Immediate Release (IR) 0.2 mg/day (twice daily) as a control.

Conditions

• Dyslipidemias

Interventions

Type	Name	Description
DRUG	K-877 ER 0.2 mg/day (once daily)	K-877 ER 0.2 mg tablet
DRUG	K-877 ER 0.4 mg/day (once daily)	K-877 ER 0.4 mg tablet
DRUG	K-877 IR 0.2 mg/day (twice daily)	K-877 IR 0.1 mg tablet

Timeline

• Start date: 2021-02-01
• Primary completion: 2021-09-25
• Completion: 2021-09-25
• First posted: 2021-01-19
• Last updated: 2024-06-20

Locations

11 sites across 1 country: Japan