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A Phase III Long Term Study of K-877 Extended Release Tablet

NCT04716595 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2025-11-24

No results posted yet for this study

Summary

To investigate the safety and efficacy of K-877 Extended Release (ER) once daily for 52 weeks in the morning or evening in dyslipidema.The starting dose of the ER tablet will be 0.2 mg/day. If the efficacy is insufficient, it will investigate the safety and efficacy of 0.4 mg/day.

Conditions

  • Dyslipidemias

Interventions

DRUG

K-877 ER 0.2 mg/day morning administration (once daily)

K-877 ER 0.2 mg tablet

DRUG

K-877 ER 0.2 mg/day evening administration (once daily)

K-877 ER 0.2 mg tablet

Sponsors & Collaborators

  • Kowa Company, Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2022-06-13
Completion
2022-06-13

Countries

  • Japan

Study Locations

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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 NCT04716595 on ClinicalTrials.gov