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K-924 Phase III Confirmatory Study

NCT04289649 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 293

Last updated 2023-11-29

No results posted yet for this study

Summary

A multicenter, active-controlled, randomized, double-blind comparative study to compare the efficacy and safety of K-924 LD tablet or K-924 HD tablet to pitavastatin 2 mg or 4 mg in patienta with hypercholesterolemia.

Conditions

Interventions

DRUG

K-924 LD

Pitavastatin 2 mg / Ezetimibe 10 mg tables

DRUG

K-924 HD

Pitavastatin 4 mg / Ezetimibe 10 mg tables

DRUG

K-924 LD Placebo

Pitavastain 2 mg

DRUG

K-924 HD Placebo

Pitavastain 4 mg

Sponsors & Collaborators

  • Kowa Company, Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-02
Primary Completion
2020-11-21
Completion
2020-11-21

Countries

  • Japan

Study Locations

More Related Trials

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 NCT04289649 on ClinicalTrials.gov