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

NCT04714151 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 356

Last updated 2024-06-20

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Kowa Company, Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2021-09-25
Completion
2021-09-25

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 NCT04714151 on ClinicalTrials.gov