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Study to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting High Triglyceride Levels and Mild or Moderate Renal Impairment

NCT03011450 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 471

Last updated 2022-10-28

Study results available
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Summary

The purpose of this study is to evaluate the efficacy and safety of K-877 in adult patients With Fasting High Triglyceride Levels ≥500 mg/dL and \<2000 mg/dL and Mild or Moderate Renal Impairment.

Conditions

Interventions

DRUG

K-877

DRUG

Fenofibrate

DRUG

Placebo (for K-877)

Sponsors & Collaborators

  • Kowa Research Institute, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-26
Primary Completion
2019-07-05
Completion
2019-07-05
FDA Drug
Yes

Countries

  • United States
  • Belarus
  • Bulgaria
  • Czechia
  • Georgia
  • Hungary
  • Poland
  • Russia
  • Ukraine

Study Locations

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Entities

Diseases

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 NCT03011450 on ClinicalTrials.gov